Oxycodone Hydrochloride

Serious warning

The strongest warning the FDA requires. It is printed in a box at the top of the label.

Quoted from the official label, section “Boxed Warning”.

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• Oxycodone Hydrochloride Capsules should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks.
• (2.1) Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals.
• Reserve titration to higher doses of Oxycodone Hydrochloride Capsules for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks.
• (2.1, 5) Many acute pain conditions (e.g., the pain that occurs with a number of surgical procedures or acute musculoskeletal injuries) require no more than a few days of an opioid analgesic.
• Clinical guidelines on opioid prescribing for some acute pain conditions are available.
• (2.1) Initiate the dosing regimen for each patient individually, taking into account the patient’s underlying cause and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse.
• (2.1, 5.1) Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with Oxycodone Hydrochloride Capsules.
• Consider this risk when selecting an initial dose and when making dose adjustments.
• (2.1, 5.2) Discuss opioid overdose reversal agents and options for acquiring them with the patient and/or caregiver, both when initiating and renewing treatment with Oxycodone Hydrochloride Capsules, especially if the patient has additional risk factors for overdose, or close contacts at risk for exposure and overdose.
• (2.2, 5.2, 5.3, 5.4) Initiate treatment with Oxycodone Hydrochloride Capsules in a dosing range of 5 to 15 mg every 4 to 6 hours as needed for pain, and at the lowest dose necessary to achieve adequate analgesia.
• Titrate the dose based upon the individual patient’s response to their initial dose of Oxycodone Hydrochloride Capsules.
• (2.1, 2.4) Periodically reassess patients receiving Oxycodone Hydrochloride Capsules to evaluate the continued need for opioid analgesics to maintain pain control, for the signs and symptoms of adverse reactions, and for the development of addiction, abuse, or misuse (2.4) Do not rapidly reduce or abruptly discontinue Oxycodone Hydrochloride Capsules in a physically dependent patient because rapid reduction or abrupt discontinuation of opioid analgesics has resulted in serious withdrawal symptoms, uncontrolled pain, and suicide.
• (2.5)
• 2.1 Important Dosage and Administration Instructions Oxycodone Hydrochloride Capsules should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks.
• Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals [see Warnings and Precautions (5)] .
• Because the risk of overdose increases as opioid doses increase, reserve titration to higher doses of Oxycodone Hydrochloride Capsules for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks.
• Many acute pain conditions (e.g., the pain that occurs with a number of surgical procedures or acute musculoskeletal injuries) require no more than a few days of an opioid analgesic.
• Clinical guidelines on opioid prescribing for some acute pain conditions are available.
• There is variability in the opioid analgesic dose and duration needed to adequately manage pain due both to the cause of pain and to individual patient factors.
• Initiate the dosing regimen for each patient individually, taking into account the patient’s underlying cause and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, misuse [see Warnings and Precautions (5.1)] .
• Respiratory depression can occur at any time during opioid therapy, especially when,initiating and following dosage increases with Oxycodone Hydrochloride Capsules.
• Consider this risk when selecting an initial dose and when making dose adjustments [see Warnings and Precautions (5)] .
• 2.2 Patient Access to an Opioid Overdose Reversal Agent for the Emergency Treatment of Opioid Overdose Inform patients and caregivers about opioid overdose reversal agents (e.g., naloxone, nalmefene).
• Discuss the importance of having access to an opioid overdose reversal agent, especially if the patient has risk factors for overdose (e.g., concomitant use of CNS depressants, a history of opioid use disorder, or prior opioid overdose) or if there are household members (including children) or other close contacts at risk for accidental ingestion or opioid overdose.
• The presence of risk factors for overdose should not prevent the management of pain in any patient [see Warnings and Precautions (5.1, 5.2, 5.3)].
• Discuss the options for obtaining an opioid overdose reversal agent (e.g., prescription, over-the-counter, or as part of a community-based program) [see Warnings and Precautions (5.2)] .
• There are important differences among the opioid overdose reversal agents, such as route of administration, product strength, approved patient age range, and pharmacokinetics.
• Be familiar with these differences, as outlined in the approved labeling for those products, prior to recommending or prescribing such an agent.
• 2.3 Initial Dosage Although it is not possible to list every condition that is important to the selection of the initial dose of Oxycodone Hydrochloride Capsules, attention must be given to:
• 1. the daily dose, potency and characteristics of a full agonist or mixed agonist/antagonist the patient has been taking previously 2. the reliability of the relative potency estimate to calculate the dose of oxycodone HCl needed 3. the degree of opioid tolerance 4. the general condition and medical status of the patient, including the patient’s weight and age 5. the balance between pain management and adverse reactions 6. the type and severity of the patient’s pain 7. risk factors for abuse or addiction, including a prior history of abuse or addiction Use of Oxycodone Hydrochloride Capsules as the First Opioid Analgesic Initiate treatment with Oxycodone Hydrochloride Capsules in a dosing range of 5 to 15 mg every 4 to 6 hours as needed for pain, and at the lowest dose necessary to achieve adequate analgesia.
• Titrate the dose based upon the individual patient’s response to their initial dose of Oxycodone Hydrochloride Capsules.
• Conversion from Other Opioids to Oxycodone Hydrochloride Capsules There is inter-patient variability in the potency of opioid drugs and opioid formulations.
• Therefore, a conservative approach is advised when determining the total daily dosage of Oxycodone Hydrochloride Capsules.
• It is safer to underestimate a patient’s 24-hour Oxycodone Hydrochloride Capsules dosage than to overestimate the 24-hour Oxycodone Hydrochloride Capsules dosage and manage an adverse reaction due to overdose.
• If a patient has been receiving opioid-containing medications prior to taking Oxycodone Hydrochloride Capsules, the potency of the prior opioid relative to oxycodone should be factored into the selection of the total daily dose (TDD) of oxycodone.
• In converting patients from other opioids to Oxycodone Hydrochloride Capsules, close observation and adjustment of dosage based upon the patient’s response to Oxycodone Hydrochloride Capsules is imperative.
• Administration of supplemental analgesia for breakthrough or incident pain and titration of the total daily dose of Oxycodone Hydrochloride Capsules may be necessary, especially in patients who have disease states that are changing rapidly.
• Conversion from Oxycodone Hydrochloride Capsules to Extended-Release Oxycodone The relative bioavailability of Oxycodone Hydrochloride Capsules compared to extended-release oxycodone is unknown, so conversion to extended-release oxycodone may lead to increased risk of excessive sedation and respiratory depression.
• 2.4 Titration and Maintenance of Therapy Individually titrate Oxycodone Hydrochloride Capsules to a dose that provides adequate analgesia and minimizes adverse reactions.
• Continually reevaluate patients receiving Oxycodone Hydrochloride Capsules to assess the maintenance of pain control, signs and symptoms of opioid withdrawal, and other adverse reactions, as well as to reassessfor the development of addiction, abuse, or misuse [see Warnings and Precautions (5.1)] .
• Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration.
• If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the Oxycodone Hydrochloride Capsules dosage.
• If after increasing the dosage, unacceptable opioid-related adverse reactions are observed (including an increase in pain after a dosage increase), consider reducing the dosage [see Warnings and Precautions (5)] .
• Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions.
• 2.5 Safe Reduction or Discontinuation of Oxycodone Hydrochloride Capsules Do not rapidly reduce or abruptly discontinue Oxycodone Hydrochloride Capsules in patients who may be physically dependent on opioids.
• Rapid reduction or abrupt discontinuation of opioid analgesics in patients who are physically dependent on opioids has resulted in serious withdrawal symptoms, uncontrolled pain, and suicide.
• Rapid reduction or abrupt discontinuation has also been associated with attempts to find other sources of opioid analgesics, which may be confused with drug-seeking for abuse.
• Patients may also attempt to treat their pain or withdrawal symptoms with illicit opioids, such as heroin, and other substances.
• When a decision has been made to decrease the dose or discontinue therapy in an opioid-dependent patient taking Oxycodone Hydrochloride Capsules, there are a variety of factors that should be considered, including the total daily of opioid (including Oxycodone Hydrochloride Capsules) the patient has been taking, the duration of treatment, the type of pain being treated, and the physical and psychological attributes of the patient.
• It is important to ensure ongoing care of the patient and to agree on an appropriate tapering schedule and follow-up plan so that patient and provider goals and expectations are clear and realistic.
• When opioid analgesics are being discontinued due to a suspected substance use disorder, evaluate and treat the patient, or refer for evaluation and treatment of the substance use disorder.
• Treatment should include evidence-based approaches, such as medication assisted treatment of opioid use disorder.
• Complex patients with co-morbid pain and substance use disorders may benefit from referral to a specialist.
• There are no standard opioid tapering schedules that are suitable for all patients.
• Good clinical practice dictates a patient-specific plan to taper the dose of the opioid gradually.
• For patients on Oxycodone Hydrochloride Capsules who are physically opioid-dependent, initiate the taper by a small enough increment (e.g., no greater than 10% to 25% of the total daily dose) to
• avoid withdrawal symptoms, and proceed with dose-lowering at an interval of every 2 to 4 weeks.
• Patients who have been taking opioids for briefer periods of time may tolerate a more rapid taper.
• It may be necessary to provide the patient with lower dosage strengths to accomplish a successful taper.
• Reassess the patient frequently to manage pain and withdrawal symptoms, should they emerge.
• Common withdrawal symptoms include restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis.
• Other signs and symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate.
• If withdrawal symptoms arise, it may be necessary to pause the taper for a period of time or raise the dose of the opioid analgesic to the previous dose, and then proceed with a slower taper.
• In addition, evaluate patients for any changes in mood, emergence of suicidal thoughts, or use of other substances.
• When managing patients taking opioid analgesics, particularly those who have been treated for an extended period of time, and/or with high doses for chronic pain, ensure that a multimodal approach to pain management, including mental health support (if needed), is in place prior to initiating an opioid analgesic taper.
• A multimodal approach to pain management may optimize the treatment of chronic pain, as well as assist with the successful tapering of the opioid analgesic [see Warnings and Precautions (5.14), Drug Abuse and Dependence (9.3)] .
• 2.1 Important Dosage and Administration Instructions Oxycodone Hydrochloride Capsules should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks.
• Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals [see Warnings and Precautions (5)] .
• Because the risk of overdose increases as opioid doses increase, reserve titration to higher doses of Oxycodone Hydrochloride Capsules for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks.
• Many acute pain conditions (e.g., the pain that occurs with a number of surgical procedures or acute musculoskeletal injuries) require no more than a few days of an opioid analgesic.
• Clinical guidelines on opioid prescribing for some acute pain conditions are available.
• There is variability in the opioid analgesic dose and duration needed to adequately manage pain due both to the cause of pain and to individual patient factors.
• Initiate the dosing regimen for each patient individually, taking into account the patient’s underlying cause and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, misuse [see Warnings and Precautions (5.1)] .
• Respiratory depression can occur at any time during opioid therapy, especially when,initiating and following dosage increases with Oxycodone Hydrochloride Capsules.
• Consider this risk when selecting an initial dose and when making dose adjustments [see Warnings and Precautions (5)] .
• 2.2 Patient Access to an Opioid Overdose Reversal Agent for the Emergency Treatment of Opioid Overdose Inform patients and caregivers about opioid overdose reversal agents (e.g., naloxone, nalmefene).
• Discuss the importance of having access to an opioid overdose reversal agent, especially if the patient has risk factors for overdose (e.g., concomitant use of CNS depressants, a history of opioid use disorder, or prior opioid overdose) or if there are household members (including children) or other close contacts at risk for accidental ingestion or opioid overdose.
• The presence of risk factors for overdose should not prevent the management of pain in any patient [see Warnings and Precautions (5.1, 5.2, 5.3)].
• Discuss the options for obtaining an opioid overdose reversal agent (e.g., prescription, over-the-counter, or as part of a community-based program) [see Warnings and Precautions (5.2)] .
• There are important differences among the opioid overdose reversal agents, such as route of administration, product strength, approved patient age range, and pharmacokinetics.
• Be familiar with these differences, as outlined in the approved labeling for those products, prior to recommending or prescribing such an agent.
• 2.3 Initial Dosage Although it is not possible to list every condition that is important to the selection of the initial dose of Oxycodone Hydrochloride Capsules, attention must be given to:
• 1. the daily dose, potency and characteristics of a full agonist or mixed agonist/antagonist the patient has been taking previously 2. the reliability of the relative potency estimate to calculate the dose of oxycodone HCl needed 3. the degree of opioid tolerance 4. the general condition and medical status of the patient, including the patient’s weight and age 5. the balance between pain management and adverse reactions 6. the type and severity of the patient’s pain 7. risk factors for abuse or addiction, including a prior history of abuse or addiction Use of Oxycodone Hydrochloride Capsules as the First Opioid Analgesic Initiate treatment with Oxycodone Hydrochloride Capsules in a dosing range of 5 to 15 mg every 4 to 6 hours as needed for pain, and at the lowest dose necessary to achieve adequate analgesia.
• Titrate the dose based upon the individual patient’s response to their initial dose of Oxycodone Hydrochloride Capsules.
• Conversion from Other Opioids to Oxycodone Hydrochloride Capsules There is inter-patient variability in the potency of opioid drugs and opioid formulations.
• Therefore, a conservative approach is advised when determining the total daily dosage of Oxycodone Hydrochloride Capsules.
• It is safer to underestimate a patient’s 24-hour Oxycodone Hydrochloride Capsules dosage than to overestimate the 24-hour Oxycodone Hydrochloride Capsules dosage and manage an adverse reaction due to overdose.
• If a patient has been receiving opioid-containing medications prior to taking Oxycodone Hydrochloride Capsules, the potency of the prior opioid relative to oxycodone should be factored into the selection of the total daily dose (TDD) of oxycodone.
• In converting patients from other opioids to Oxycodone Hydrochloride Capsules, close observation and adjustment of dosage based upon the patient’s response to Oxycodone Hydrochloride Capsules is imperative.
• Administration of supplemental analgesia for breakthrough or incident pain and titration of the total daily dose of Oxycodone Hydrochloride Capsules may be necessary, especially in patients who have disease states that are changing rapidly.
• Conversion from Oxycodone Hydrochloride Capsules to Extended-Release Oxycodone The relative bioavailability of Oxycodone Hydrochloride Capsules compared to extended-release oxycodone is unknown, so conversion to extended-release oxycodone may lead to increased risk of excessive sedation and respiratory depression.
• 2.4 Titration and Maintenance of Therapy Individually titrate Oxycodone Hydrochloride Capsules to a dose that provides adequate analgesia and minimizes adverse reactions.
• Continually reevaluate patients receiving Oxycodone Hydrochloride Capsules to assess the maintenance of pain control, signs and symptoms of opioid withdrawal, and other adverse reactions, as well as to reassessfor the development of addiction, abuse, or misuse [see Warnings and Precautions (5.1)] .
• Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration.
• If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the Oxycodone Hydrochloride Capsules dosage.
• If after increasing the dosage, unacceptable opioid-related adverse reactions are observed (including an increase in pain after a dosage increase), consider reducing the dosage [see Warnings and Precautions (5)] .
• Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions.
• 2.5 Safe Reduction or Discontinuation of Oxycodone Hydrochloride Capsules Do not rapidly reduce or abruptly discontinue Oxycodone Hydrochloride Capsules in patients who may be physically dependent on opioids.
• Rapid reduction or abrupt discontinuation of opioid analgesics in patients who are physically dependent on opioids has resulted in serious withdrawal symptoms, uncontrolled pain, and suicide.
• Rapid reduction or abrupt discontinuation has also been associated with attempts to find other sources of opioid analgesics, which may be confused with drug-seeking for abuse.
• Patients may also attempt to treat their pain or withdrawal symptoms with illicit opioids, such as heroin, and other substances.
• When a decision has been made to decrease the dose or discontinue therapy in an opioid-dependent patient taking Oxycodone Hydrochloride Capsules, there are a variety of factors that should be considered, including the total daily of opioid (including Oxycodone Hydrochloride Capsules) the patient has been taking, the duration of treatment, the type of pain being treated, and the physical and psychological attributes of the patient.
• It is important to ensure ongoing care of the patient and to agree on an appropriate tapering schedule and follow-up plan so that patient and provider goals and expectations are clear and realistic.
• When opioid analgesics are being discontinued due to a suspected substance use disorder, evaluate and treat the patient, or refer for evaluation and treatment of the substance use disorder.
• Treatment should include evidence-based approaches, such as medication assisted treatment of opioid use disorder.
• Complex patients with co-morbid pain and substance use disorders may benefit from referral to a specialist.
• There are no standard opioid tapering schedules that are suitable for all patients.
• Good clinical practice dictates a patient-specific plan to taper the dose of the opioid gradually.
• For patients on Oxycodone Hydrochloride Capsules who are physically opioid-dependent, initiate the taper by a small enough increment (e.g., no greater than 10% to 25% of the total daily dose) to
• avoid withdrawal symptoms, and proceed with dose-lowering at an interval of every 2 to 4 weeks.
• Patients who have been taking opioids for briefer periods of time may tolerate a more rapid taper.
• It may be necessary to provide the patient with lower dosage strengths to accomplish a successful taper.
• Reassess the patient frequently to manage pain and withdrawal symptoms, should they emerge.
• Common withdrawal symptoms include restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis.
• Other signs and symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate.
• If withdrawal symptoms arise, it may be necessary to pause the taper for a period of time or raise the dose of the opioid analgesic to the previous dose, and then proceed with a slower taper.
• In addition, evaluate patients for any changes in mood, emergence of suicidal thoughts, or use of other substances.
• When managing patients taking opioid analgesics, particularly those who have been treated for an extended period of time, and/or with high doses for chronic pain, ensure that a multimodal approach to pain management, including mental health support (if needed), is in place prior to initiating an opioid analgesic taper.
• A multimodal approach to pain management may optimize the treatment of chronic pain, as well as assist with the successful tapering of the opioid analgesic [see Warnings and Precautions (5.14), Drug Abuse and Dependence (9.3)] .

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Misuse and dependence

Quoted from the official label, section “Drug Abuse and Dependence”.

Use in children

• The safety and effectiveness of Oxycodone Hydrochloride Capsules have not been established in pediatric patients.
• The safety and pharmacokinetics of a single-dose of an Oxycodone Hydrochloride Oral Solution were evaluated in an open-label clinical trial in 89 pediatric patients 2 years to less than 17 years of age with postoperative pain.
• However, definitive conclusions are not possible because of insufficient information.

Quoted from the official label, section “Pediatric Use”.

Use in older people

• Elderly patients (aged 65 years or older) may have increased sensitivity to oxycodone.
• In general, use caution when selecting a dose for an elderly patient, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.
• Respiratory depression is the chief risk for elderly patients treated with opioids, and has occurred after large initial doses were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration.
• Titrate the dosage of Oxycodone Hydrochloride Capsules slowly in geriatric patients and frequently reevaluate the patient for signs of central nervous system and respiratory depression [see Warnings and Precautions (5.2)].
• Oxycodone is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function.
• Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to regularly evaluate renal function.

Quoted from the official label, section “Geriatric Use”.

Side effects

• The following serious adverse reactions are described, or described in greater detail, in other sections:
• Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1)] Life-Threatening Respiratory Depression [see Warnings and Precautions (5.2)] Interactions with Benzodiazepines or Other CNS Depressants [see Warnings and Precautions (5.3)] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.4)] Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions (5.7)] Adrenal Insufficiency [see Warnings and Precautions (5.9)] Severe Hypotension [see Warnings and Precautions (5.10)] Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.12)] Seizures [see Warnings and Precautions (5.13)] Withdrawal [see Warnings and Precautions (5.14)] The following adverse reactions associated with the use of oxycodone were identified in clinical studies or postmarketing reports.
• Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
• Serious adverse reactions associated with oxycodone use included:
• respiratory depression, respiratory arrest, circulatory depression, cardiac arrest, hypotension, and/or shock.
• The common adverse reactions seen on initiation of therapy with oxycodone are dose-related and are typical opioid-related adverse reactions.
• The most frequent adverse events include nausea, constipation, vomiting, headache, and pruritus.
• The frequency of these reactions depended on several factors, including clinical setting, the patient’s level of opioid tolerance, and host factors specific to the individual.
• In all patients for whom dosing information was available (n=191) from the open-label and double-blind studies involving another formulation of immediate-release oxycodone, the following adverse events were recorded in oxycodone treated patients with an incidence ≥ 3%.
• In descending order of frequency, they were:
• nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia, and somnolence.
• The other less frequently observed adverse reactions from opioid analgesics, including Oxycodone Hydrochloride Capsules included:
• Body as a Whole:
• abdominal pain, accidental injury, allergic reaction, back pain, chills and fever, fever, flu syndrome, infection, neck pain, pain, photosensitivity reaction, and sepsis.
• Cardiovascular:
• deep thrombophlebitis, heart failure, hemorrhage, hypotension, migraine, palpitation, and tachycardia.
• Digestive:
• anorexia, diarrhea, dyspepsia, dysphagia, gingivitis, glossitis, and nausea and vomiting.
• Hemic and Lymphatic: anemia and leukopenia.
• Metabolic and Nutritional:
• edema, gout, hyperglycemia, iron deficiency anemia and peripheral edema.
• Musculoskeletal: arthralgia, arthritis, bone pain, myalgia and pathological fracture.
• Nervous:
• agitation, anxiety, confusion, dry mouth, hypertonia, hypesthesia, nervousness, neuralgia, personality disorder, tremor, and vasodilation.
• Respiratory:
• bronchitis, cough increased, dyspnea, epistaxis, laryngismus, lung disorder, pharyngitis, rhinitis, and sinusitis.
• Skin and Appendages: herpes simplex, rash, sweating, and urticaria.
• Special Senses: amblyopia.
• Urogenital:
• urinary tract infection Serotonin syndrome:
• Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.
• Adrenal insufficiency:
• Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.
• Anaphylaxis:
• Anaphylaxis has been reported with ingredients contained in Oxycodone Hydrochloride Capsules.
• Androgen deficiency:
• Cases of androgen deficiency have occurred with chronic use of opioids for an extended period of time [see Clinical Pharmacology (12.2)] .
• Hyperalgesia and Allodynia :
• Cases of hyperalgesia and allodynia have been reported with opioid therapy of any duration [see Warnings and Precautions (5.7)].
• Hypoglycemia : Cases of hypoglycemia have been reported in patients taking opioids.
• Most reports were in patients with at least one predisposing risk factor (e.g., diabetes).
• Opioid-induced esophageal dysfunction (OIED) :
• Cases of OIED have been reported in patients taking opioids and may occur more frequently in patients taking higher doses of opioid, and/or in patients taking opioids longer term [see Warnings and Precautions (5.12)] .
• Adverse Reactions from Observational Studies A prospective, observational cohort study estimated the risks of addiction, abuse, and misuse in patients initiating long-term use of Schedule II opioid analgesics between 2017 and 2021.
• Study participants included in one or more analyses had been enrolled in selected insurance plans or health systems for at least one year, were free of at least one outcome at baseline, completed a minimum number of follow-up assessments, and either, 1) filled multiple extended-release/long-acting opioid analgesic prescriptions during a 90-day period (n=978); or 2) filled any Schedule II opioid analgesic prescriptions covering at least 70 of 90 days (n=1,244).
• Those included also had no dispensing of the qualifying opioids in the previous 6 months.
• Over 12 months:
• Approximately 1% to 6% of participants across the two cohorts newly met criteria for addiction, as assessed with two validated interview-based measures of moderate-to¬-severe opioid use disorder based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria, and Approximately 9% and 22% of participants across the two cohorts newly met criteria for prescription opioid abuse and misuse [defined in Drug Abuse and Dependence (9.2)]. respectively, as measured with a validated self-reported instrument.
• A retrospective, observational cohort study estimated the risk of opioid involved overdose or opioid overdose-related death in patients with new long-term use of Schedule II opioid analgesics from 2006 through 2016 (n=220,249).
• Included patients had been enrolled in either one of two commercial insurance programs, one managed care program, or one Medicaid program for at least 9 months.
• New long-term use was defined as having Schedule II opioid analgesic prescriptions covering at least 70 days’ supply over the 3 months prior to study entry and none during the preceding 6 months.
• Patients were excluded if they had an opioid-involved overdose in the 9 months prior to study entry.
• Overdose was measured using a validated medical code-based algorithm with linkage to the National Death Index database.
• The 5-year cumulative incidence estimates for opioid-involved overdose or opioid overdose-related death ranged from approximately 1.5% to 4% across study sites, counting only the first event during follow-up.
• Approximately 17% of first opioid overdoses observed over the entire study period (5-11 years, depending on the study site) were fatal.
• Higher baseline opioid dose was the strongest and most consistent predictor of opioid-involved overdose or opioid overdose-related death.
• Study exclusion criteria may have selected patients at lower risk of overdose, and substantial loss to follow-up (approximately 80%) also may have biased estimates.
• The risk estimates from the studies described above may not be generalizable to all patients receiving opioid analgesics, such as those with exposures shorter or longer than the duration evaluated in the studies.
• Most common adverse reactions are nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia, and somnolence.
• (6) To report SUSPECTED ADVERSE REACTIONS, contact KVK-TECH, INC. at 1-800-862-3895 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Advise the patient to read the FDA-approved patient labeling (Medication Guide). Storage and Disposal :
• Because of the risks associated with accidental ingestion, misuse, and abuse, advise patients to store Oxycodone Hydrochloride Capsules securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home. Inform patients that leaving Oxycodone Hydrochloride Capsules unsecured can pose a deadly risk to others in the home [see Warnings and Precautions (5.1, 5.2), Drug Abuse and Dependence (9.2)]. Advise patients and caregivers that when medicines are no longer needed, they should be disposed of promptly. Expired, unwanted, or unused Oxycodone Hydrochloride Capsules should be disposed of by flushing the unused medication down the toilet if a drug take-back option is not readily available. Inform patients that they can visit www.fda.gov/drugdisposal for a complete list of medicines recommended for disposal by flushing, as well as additional information on disposal of unused medicines. Addiction, Abuse, and Misuse Inform patients that the use of Oxycodone Hydrochloride Capsules, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death [see Warnings and Precautions (5.1)] . Instruct patients not to share Oxycodone Hydrochloride Capsules with others and to take steps to protect Oxycodone Hydrochloride Capsules from theft or misuse. Life-Threatening Respiratory Depression Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting Oxycodone Hydrochloride Capsules or when the dosage is increased, and that it can occur even at recommended dosages. Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling 911 or getting emergency medical help right away in the event of a known or suspected overdose [see Warnings and Precautions (5.2)]. Accidental Ingestion Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death [see Warnings and Precautions (5.2)]. Interactions with Benzodiazepines and Other CNS Depressants Inform patients and caregivers that potentially fatal additive effects may occur if Oxycodone Hydrochloride Capsules are used with benzodiazepines or other CNS depressants, including alcohol (e.g., non-benzodiazepine sedative/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids [gabapentin or pregabalin], and other opioids), and not to use these concomitantly unless supervised by a health care provider [see Warnings and Precautions (5.3), Drug Interactions (7)]. Patient Access to an Opioid Overdose Reversal Agent for the Emergency Treatment of Opioid Overdose Inform patients and caregivers about opioid overdose reversal agents (e.g., naloxone, nalmefene). Discuss the importance of having access to an opioid overdose reversal agent, especially if the patient has risk factors for overdose (e.g., concomitant use of CNS depressants, a history of opioid use disorder, or prior opioid overdose) or if there are household members (including children) or other close contacts at risk for accidental ingestion or opioid overdose. Discuss with the patient the options for obtaining an opioid overdose reversal agent (e.g., prescription, over-the-counter, or as part of a community-based program) [see Dosage and Administration (2.2), Warnings and Precautions (5.2)]. Educate patients and caregivers on how to recognize the signs and symptoms of an overdose. Explain to patients and caregivers that naloxone’s effects of opioid overdose reversal agents like naloxone and nalmefene are temporary, and that they must call 911 or get emergency medical help right away in all cases of known or suspected opioid overdose, even if an opioid overdose reversal agent is administered [see Overdosage (10)] . Advise patients and caregivers:
• how to treat with the overdose reversal agent in the event of an opioid overdose
• to tell family and friends about the opioid overdose reversal agent, and to keep it in a place where family and friends can access it in emergency
• to read the Patient Information (or other educational material) that will come with their opioid overdose reversal agent. Emphasize the importance of doing this before an opioid emergency happens, so the patient and caregiver will know what to do. Hyperalgesia and Allodynia Inform patients and caregivers not to increase opioid dosage without first consulting a clinician. Advise patients to seek medical attention if they experience symptoms of hyperalgesia, including worsening pain, increased sensitivity to pain, or new pain [see Warnings and Precautions (5.7), Adverse Reactions (6)]. Serotonin Syndrome Inform patients that opioids could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away
• if symptoms develop. Instruct patients to inform their healthcare providers if they are taking, or plan to take serotonergic medications [see Drug Interactions (7)]. MAOI Interaction Inform patients to
• avoid taking Oxycodone Hydrochloride Capsules while using any drugs that inhibit monoamine oxidase. Patients should not start MAOIs while taking Oxycodone Hydrochloride Capsules [see Drug Interactions (7)]. Important Administration Instructions Instruct patients how to properly take Oxycodone Hydrochloride Capsules. Patients should be advised not to adjust the dose of Oxycodone Capsules without consulting the prescribing healthcare provider [see Dosage and Administration (2)]. Important Discontinuation Instructions In order to
• avoid developing withdrawal symptoms, instruct patients not to discontinue Oxycodone Hydrochloride Capsules without first discussing a tapering plan with the prescriber [see Dosage and Administration (2.5)]. Driving or Operating Heavy Machinery Inform patients that Oxycodone Hydrochloride Capsules may impair the ability to perform potentially hazardous activities such as driving a car or operating heavy machinery. Advise patients not to perform such tasks until they know how they will react to the medication [see Warnings and Precautions (5.15)]. Constipation Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention [see Adverse Reactions (6), Clinical Pharmacology (12.2)]. Adrenal Insufficiency Inform patients that opioids could cause adrenal insufficiency, a potentially life- threatening condition. Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. Advise patients to seek medical attention if they experience a constellation of these symptoms [see Warnings and Precautions (5.9)]. Hypotension Inform patients that Oxycodone Hydrochloride Capsules may cause orthostatic hypotension and syncope. Instruct patients how to recognize symptoms of low blood pressure and how to reduce the risk of serious consequences should hypotension occur (e.g., sit or lie down, carefully rise from a sitting or lying position) [see Warnings and Precautions (5.10)]. Anaphylaxis Inform patients that anaphylaxis has been reported with ingredients contained in Oxycodone Hydrochloride Capsules. Advise patients how to recognize such a reaction and when to seek medical attention [see Adverse Reactions (6)] . Pregnancy Neonatal Opioid Withdrawal Syndrome Inform female patients of reproductive potential that use of Oxycodone Hydrochloride Capsules for an extended period of time during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated [see Warnings and Precautions (5.4), Use in Specific Populations (8.1)]. Embryo-Fetal Toxicity Inform female patients of reproductive potential that Oxycodone Hydrochloride Capsules can cause fetal harm and to inform the healthcare provider of a known or suspected pregnancy [see Use in Specific Populations (8.1)]. Lactation Advise breastfeeding women using Oxycodone Hydrochloride Capsules to carefully observe infants for increased sleepiness (more than usual), breathing difficulties, or limpness. Instruct breastfeeding women to seek immediate medical care if they notice these signs [see Use in Specific Populations (8.2)]. Infertility Inform patients that use of opioids for an extended period of time may cause reduced fertility. It is not known whether these effects on fertility are reversible [see Use in Specific Populations (8.3)]. Manufactured by:
• KVK-Tech, Inc. 110 Terry Drive Newtown, PA 18940 Item ID#:
• 6046/07 04/2026 Manufacturer’s Code:
• 10702 company logo

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS Oxycodone Hydrochloride Capsules, USP Capsules 5 mg:
• Each capsule has a light brown opaque cap, peach opaque body with black imprint “K 23” on both cap and body, filled with powder containing 5 mg of oxycodone hydrochloride, USP.
• Immediate-release capsules: 5 mg (3)

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• Oxycodone Hydrochloride Capsule 5 mg is a hard gelatin capsule with a light brown opaque cap, peach opaque body with black imprint “K 23” on both cap and body, filled with powder, supplied as:
• NDC# 10702-023-06:
• Bottle of 60 Capsules NDC# 10702-023-01:
• Bottle of 100 Capsules Dispense in a tight, light-resistant container.
• Protect from moisture and light.
• Store at 25°C (77°F); excursions are permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
• Store Oxycodone Hydrochloride Capsules securely and dispose of properly [see Patient Counseling Information 17)].

Quoted from the official label, section “How Supplied”.

What is in it

• Oxycodone Hydrochloride Capsule are an agonist, available as a hard gelatin capsule 5 mg for oral administration. The chemical name is (5R,9R,13S,14S)-4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 351.82. Its molecular formula is C 18 H 21 NO 4
• HCl, and it has the following chemical structure. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. It is soluble in water and slightly soluble in alcohol. The inactive ingredients in Oxycodone Hydrochloride Capsules, 5 mg include:
• black iron oxide, colloidal silicon dioxide, FD&C Yellow #6, gelatin, red iron oxide, starch pregelatinized (corn), stearic acid, titanium dioxide, and yellow iron oxide. The imprinting on the hard gelatin capsule is black ink. figure-01-chemical-structure

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Same active substance, strength and form in other countries

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

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Same active substance

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