Trazodone 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.

• Starting dose: 150 mg in divided doses daily.
• May be increased by 50 mg per day every three to four days.
• Maximum dose: 400 mg per day in divided doses ( 2.1 ).
• Trazodone hydrochloride tablets should be taken shortly after a meal or light snack ( 2.2 ).
• Tablets should be swallowed whole or broken in half along the score line ( 2.2 ).
• When discontinued, gradual dose reduction is recommended ( 2.6 ).
• 2.1 Dose Selection An initial dose of 150 mg/day in divided doses is suggested.
• The dosage should be initiated at a low-dose and increased gradually, noting the clinical response and any evidence of intolerance.
• Occurrence of drowsiness may require the administration of a major portion of the daily dose at bedtime or a reduction of dosage.
• The dose may be increased by 50 mg/day every 3 to 4 days.
• The maximum dose for outpatients usually should not exceed 400 mg/day in divided doses.
• Inpatients (i.e., more severely depressed patients) may be given up to but not in excess of 600 mg/day in divided doses.
• Once an adequate response has been achieved, dosage may be gradually reduced, with subsequent adjustment depending on therapeutic response.
• 2.2 Important Administration Instructions Trazodone hydrochloride tablets can be swallowed whole or administered as a half tablet by breaking the tablet along the score line.
• Trazodone hydrochloride tablets should be taken shortly after a meal or light snack.
• 2.3 Screen for Bipolar Disorder Prior to Starting Trazodone Hydrochloride Tablets Prior to initiating treatment with trazodone hydrochloride tablets or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions (5.7) ].
• 2.4 Switching to or from Monoamine Oxidase Inhibitor Antidepressant At least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI) antidepressant and initiation of trazodone hydrochloride tablets.
• In addition, at least 14 days must elapse after stopping trazodone hydrochloride tablets before starting an MAOI antidepressant [see Contraindications (4) , Warnings and Precautions (5.2) ].
• 2.5 Dosage Recommendations for Concomitant Use with Strong CYP3A4 Inhibitors or Inducers Coadministration with Strong CYP3A4 Inhibitors Consider reducing trazodone hydrochloride tablets dose based on tolerability when trazodone hydrochloride tablets is coadministered with a strong CYP3A4 inhibitor [see Drug Interactions (7.1) ].
• Coadministration with Strong CYP3A4 Inducers Consider increasing trazodone hydrochloride tablets dose based on therapeutic response when trazodone hydrochloride tablets is coadministered with a strong CYP3A4 inducer [see Drug Interactions (7.1) ].
• 2.6 Discontinuation of Treatment with Trazodone Hydrochloride Tablets Adverse reactions may occur upon discontinuation of trazodone hydrochloride tablets [see Warnings and Precautions (5.8) ].
• Gradually reduce the dosage rather than stopping trazodone hydrochloride tablets abruptly whenever possible.

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

Safety and effectiveness in the pediatric population have not been established. Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric patients [see Boxed Warning, Warnings and Precautions (5.1) ].

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

Use in older people

• Reported clinical literature and experience with trazodone has not identified differences in responses between elderly and younger patients.
• However, as experience in the elderly with trazodone hydrochloride is limited, it should be used with caution in geriatric patients.
• Serotonergic antidepressants have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse reaction [see Warnings and Precautions (5.11) ] .

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

Side effects

• The following serious adverse reactions are described elsewhere in the labeling:
• Suicidal Thoughts and Behavior in Children, Adolescents and Young
• Adults [see Boxed Warning and Warnings and Precautions (5.1) ] Serotonin Syndrome [see Warnings and Precautions (5.2) ] Cardiac Arrhythmias [see Warnings and Precautions (5.3) ] Orthostatic Hypotension and Syncope [see Warnings and Precautions (5.4) ] Increased Risk of Bleeding [see Warnings and Precautions (5.5) ] Priapism [see Warnings and Precautions (5.6) ] Activation of Mania or Hypomania [see Warnings and Precautions (5.7) ] Discontinuation Syndrome [see Warnings and Precautions (5.8) ] Potential for Cognitive and Motor Impairment [see Warnings and Precautions (5.9) ] Angle-Closure Glaucoma [see Warnings and Precautions (5.10) ] Hyponatremia [see Warnings and Precautions (5.11) ] Most common adverse reactions (incidence ≥ 5% and twice that of placebo) are:
• edema, blurred vision, syncope, drowsiness, fatigue, diarrhea, nasal congestion, weight loss ( 6 ).
• To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-406-7984 or drugsafety@sunpharma.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
• 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
• Table 2:
• Common Adverse Reactions Occurring in ≥ 2% of Trazodone Hydrochloride Tablets-treated Patients and Greater than the Rate of Placebo-Treated Patients as Observed in Controlled Clinical Studies Inpatients Outpatients Trazodone Hydrochloride Tablets N = 142 Placebo N=95 Trazodone Hydrochloride Tablets N=157 Placebo N=158 Allergic Skin Condition/Edema 3% 1% 7% 1% Autonomic Blurred Vision 6% 4% 15% 4% Constipation 7% 4% 8% 6% Dry Mouth 15% 8% 34% 20% Cardiovascular Hypertension 20% 1% 1% * Hypotension 7% 1% 4% 0 Syncope 3% 2% 5% 1% CNS Confusion 5% 0 6% 8% Decreased Concentration 3% 2% 1% 0 Disorientation 2% 0 * 0 Dizziness/Light-Headedness 20% 5% 28% 15% Drowsiness 24% 6% 41% 20% Fatigue 11% 4% 6% 3% Headache 10% 5% 20% 16% Nervousness 15% 11% 6% 8% Gastrointestinal Abdominal/Gastric Disorder 4% 4% 6% 4% Diarrhea 0 1% 5% 1% Nausea/Vomiting 10% 1% 13% 10% Musculoskeletal Aches/Pains 6% 3% 5% 3% Neurological Incoordination 5% 0 2% * Tremors 3% 1% 5% 4% Other Eyes Red/Tired/Itching 3% 0 0 0 Head Full-Heavy 3% 0 0 0 Malaise 3% 0 0 0 Nasal/Sinus Congestion 3% 0 6% 3% Weight Gain 1% 0 5% 2% Weight Loss * 3% 6% 3% Other adverse reactions occurring at an incidence of <2% with the use of trazodone hydrochloride in the controlled clinical studies:
• akathisia, allergic reaction, anemia, chest pain, delayed urine flow, early menses, flatulence, hallucinations/delusions, hematuria, hypersalivation, hypomania, impaired memory, impaired speech, impotence, increased appetite, increased libido, increased urinary frequency, missed periods, muscle twitches, numbness, paresthesia, retrograde ejaculation, shortness of breath, and tachycardia/palpitations.
• Occasional sinus bradycardia has occurred in long-term studies.
• 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of trazodone hydrochloride tablets.
• Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure:
• Blood and lymphatic system disorders:
• hemolytic anemia, leukocytosis Cardiac disorders:
• cardiospasm, congestive heart failure, conduction block, orthostatic hypotension and syncope, palpitations, bradycardia, atrial fibrillation, myocardial infarction, cardiac arrest, arrhythmia, ventricular ectopic activity, including ventricular tachycardia and QT prolongation.
• Prolonged QT interval, torsade de pointes, and ventricular tachycardia have been reported at doses of 100 mg per day or less [see Warnings and Precautions (5.3) ].
• Endocrine disorders:
• inappropriate ADH syndrome Eye disorders:
• diplopia Gastrointestinal disorders:
• increased salivation, nausea/vomiting General disorders and administration site conditions:
• chills, edema, unexplained death, weakness Hepatobiliary disorders:
• cholestasis, jaundice, hyperbilirubinemia, liver enzyme alterations Investigations:
• increased amylase Metabolism and nutrition disorders:
• methemoglobinemia Nervous system disorders:
• aphasia, ataxia, cerebrovascular accident, extrapyramidal symptoms, grand mal seizures, paresthesia, tardive dyskinesia, vertigo Psychiatric disorders:
• abnormal dreams, agitation, anxiety, hallucinations, insomnia, paranoid reaction, psychosis, stupor Renal and urinary disorders:
• urinary incontinence, urinary retention Reproductive system and breast disorders:
• breast enlargement or engorgement, clitorism, lactation, priapism [see Warnings and Precautions (5.6) ] Respiratory, thoracic and mediastinal disorders:
• apnea Skin and subcutaneous tissue disorders:
• alopecia, hirsutism, leukonychia, pruritus, psoriasis, rash, urticaria Vascular disorders:
• vasodilation

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).
• Suicidal Thoughts and Behaviors Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dosage is adjusted up or down and instruct them to report such symptoms to the healthcare provider [ see Box Warning and Warnings and Precautions (5.1) ].
• Dosage and Administration Advise patients that trazodone hydrochloride tablets should be taken shortly after a meal or light snack.
• Advise patients regarding the importance of following dosage titration instructions [see Dosage and Administration (2) ] .
• Serotonin Syndrome Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of trazodone hydrochloride tablets with other serotonergic drugs including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St.
• John’s Wort, and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid).
• Patients should contact their health care provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome [see Warnings and Precautions (5.2) and Drug Interactions (7) ] .
• Activation of Mania/Hypomania Advise patients and their caregivers to observe for signs of activation of mania/hypomania and instruct them to report such symptoms to the healthcare provider [see Warnings and Precautions (5.7) ] .
• Increased Risk of Bleeding Inform patients about the concomitant use of trazodone hydrochloride tablets with aspirin, NSAIDs, other antiplatelet drugs, warfarin, or other anticoagulants because the combined use of drugs that interfere with serotonin reuptake and these medications has been associated with an increased risk of bleeding.
• Advise them to inform their health care providers if they are taking or planning to take any prescription or over-the-counter medications that increase the risk of bleeding [see Warnings and Precautions (5.5) ] .
• Discontinuation Syndrome Advise patients not to abruptly discontinue trazodone hydrochloride tablets and to discuss any tapering regimen with their healthcare provider.
• Adverse reactions can occur when trazodone hydrochloride tablets are discontinued [see Warnings and Precautions (5.8) ].
• Concomitant Medications Advise patients to inform their health care providers if they are taking, or plan to take any prescription or over-the-counter medications since there is a potential for interactions [see Drug Interactions (7.1) ].
• Pregnancy Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during therapy with trazodone hydrochloride tablets.
• Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to trazodone hydrochloride tablets during pregnancy [ see Use in Special Populations (8.1) ].
• Repackaged By / Distributed By:
• RemedyRepack Inc. 625 Kolter Drive, Indiana, PA 15701 (724) 465-8762

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

Strengths and forms

• FORMS AND STRENGTHS Trazodone hydrochloride tablets, USP are available in the following strengths:
• Trazodone hydrochloride tablets, USP 50 mg are white, round, convex, bisected, film-coated tablets, debossed ‘S/14’ on one side and having ‘break-line’ on other side Bisectable tablets of 50 mg ( 3 ).

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

What it looks like and how it is packed

• Trazodone hydrochloride tablets, USP are available as follows:
• Trazodone hydrochloride tablets, USP 50 mg are white, round, convex, bisected, film-coated tablets, debossed 'S/14' on one side and having break-line on other side.
• NDC:
• 70518-4363-00 NDC:
• 70518-4363-01 PACKAGING:
• 60 in 1 BOTTLE PLASTIC PACKAGING:
• 30 in 1 BOTTLE PLASTIC
• Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.
• Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr.
• Suite #4 Indiana, PA 1-724-465-8762

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

What is in it

• Trazodone hydrochloride tablets, USP for oral administration contain trazodone hydrochloride, a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist.
• Trazodone hydrochloride is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-1,2,4-triazolo[4,3-a]pyridin-3(2 H )-one hydrochloride.
• It is a white, odorless crystalline powder which is freely soluble in water.
• The structural formula is represented as follows:
• Molecular Formula:
• C 19 H 22 ClN 5 O ∙ HCl Molecular Weight:
• 408.33 Each tablet, for oral administration, contains 50 mg, 100 mg or 150 mg of trazodone hydrochloride, USP.
• Trazodone hydrochloride tablets, USP, 50 mg and 100 mg, contain the following inactive ingredients:
• anhydrous lactose, carnauba wax, colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, and titanium dioxide.
• Trazodone hydrochloride tablets, USP, 150 mg, contain the following inactive ingredients:
• anhydrous lactose, colloidal silicon dioxide, crospovidone, magnesium stearate, and microcrystalline cellulose. 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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Same active substance

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