Medicine guide

Ticagrelor

90 mg · Tablet, Film Coated

  • Prescription only
  • P2Y12 Platelet Inhibitor
Active substance
Ticagrelor
Made by
Hisun Pharmaceuticals USA, Inc.

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2026-08-06

What it is

P2Y12 Platelet Inhibitor

Used for
  • Ticagrelor is a P2Y 12 platelet inhibitor indicated to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events.
The label’s usual adult dose

Patients with CAD and No Prior Stroke or MI Administer 60 mg ticagrelor tablets twice daily.

Full directions ↓
Serious warning

BLEEDING RISK Ticagrelor, like other antiplatelet agents, can cause significant, sometimes fatal bleeding ( 5.1 , 6.1 ).

All warnings ↓
Good to know
  • Prescription only
  • FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
54other products contain Ticagrelor — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

  • Ticagrelor is a P2Y 12 platelet inhibitor indicated to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events.
  • While use is not limited to this setting, the efficacy of Ticagrelor was established in a population with type 2 diabetes mellitus (T2DM).
  • ( 1.2 ) to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score ≤5) or high-risk transient ischemic attack (TIA).
  • ( 1.3 )
  • 1.2 Coronary Artery Disease but No Prior Stroke or Myocardial Infarction Ticagrelor is indicated to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events [see Clinical Studies ( 14.2 )] .
  • While use is not limited to this setting, the efficacy of Ticagrelor was established in a population with type 2 diabetes mellitus (T2DM).
  • 1.3 Acute Ischemic Stroke or Transient Ischemic Attack (TIA) Ticagrelor is indicated to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score ≤5) or high-risk transient ischemic attack (TIA) [see Clinical Studies ( 14.3 )] .
  • 1.2 Coronary Artery Disease but No Prior Stroke or Myocardial Infarction Ticagrelor is indicated to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events [see Clinical Studies ( 14.2 )] .
  • While use is not limited to this setting, the efficacy of Ticagrelor was established in a population with type 2 diabetes mellitus (T2DM).
  • 1.3 Acute Ischemic Stroke or Transient Ischemic Attack (TIA) Ticagrelor is indicated to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score ≤5) or high-risk transient ischemic attack (TIA) [see Clinical Studies ( 14.3 )] .

From the official label · 2026-08-06 · DailyMed

How it works

From this product’s own US prescribing label.

Ticagrelor and its major metabolite reversibly interact with the platelet P2Y 12 ADP-receptor to prevent signal transduction and platelet activation.

Ticagrelor and its active metabolite are approximately equipotent.

How the body breaks it down

Effects of Ticagrelor Tablets on Other Drugs In vitro metabolism studies demonstrate that ticagrelor and its major active metabolite are weak inhibitors of CYP3A4, potential activators of CYP3A5 and inhibitors of the P-gp transporter.

With food

Ticagrelor can be taken with or without food.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-08-06

Serious warning

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

  • BLEEDING RISK Ticagrelor, like other antiplatelet agents, can cause significant, sometimes fatal bleeding ( 5.1 , 6.1 ).
  • Do not use ticagrelor in patients with active pathological bleeding or a history of intracranial hemorrhage ( 4.1 , 4.2 ).
  • Do not start ticagrelor in patients undergoing urgent coronary artery bypass graft surgery (CABG) ( 5.1 , 6.1 ).
  • If possible, manage bleeding without discontinuing ticagrelor.
  • Stopping ticagrelor increases the risk of subsequent cardiovascular events ( 5.2 ).
  • See full prescribing information for complete boxed warning.
  • Ticagrelor, like other antiplatelet agents, can cause significant, sometimes fatal bleeding.
  • ( 5.1 , 6.1 )
  • Do not use ticagrelor in patients with active pathological bleeding or a history of intracranial hemorrhage.
  • ( 4.1 , 4.2 ) Do not start ticagrelor in patients undergoing urgent coronary artery bypass graft surgery (CABG).
  • ( 5.1 , 6.1 ) If possible, manage bleeding without discontinuing ticagrelor.
  • Stopping ticagrelor increases the risk of subsequent cardiovascular events.
  • ( 5.2 )

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

Do not take it if

  • History of intracranial hemorrhage ( 4.1 ) Active pathological bleeding ( 4.2 ) Hypersensitivity to ticagrelor or any component of the product ( 4.3 )
  • 4.1 History of Intracranial Hemorrhage Ticagrelor is contraindicated in patients with a history of intracranial hemorrhage (ICH) because of a high risk of recurrent ICH in this population [see Clinical Studies ( 14.1 , 14.2 )] .
  • 4.2 Active Bleeding Ticagrelor is contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 )].
  • 4.3 Hypersensitivity Ticagrelor is contraindicated in patients with hypersensitivity (e.g., angioedema) to ticagrelor or any component of the product.

Quoted from the official label, section “Contraindications”.

How to take it

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

  • Patients with CAD and No Prior Stroke or MI Administer 60 mg ticagrelor tablets twice daily.
  • ( 2.3 ) Acute Ischemic Stroke Initiate treatment with 180 mg loading dose of ticagrelor tablets then continue with 90 mg twice daily for up to 30 days.
  • ( 2.4 ) Use ticagrelor tablets with a daily maintenance dose of aspirin of 75-100 mg.
  • ( 2 )
  • 2.1 General Instructions Advise patients who miss a dose of ticagrelor tablets to take their next dose at its scheduled time.
  • For patients who are unable to swallow tablets whole, ticagrelor tablets can be crushed, mixed with water, and drunk.
  • The mixture can also be administered via a nasogastric tube (CH8 or greater) [see Clinical Pharmacology ( 12.3 )].
  • Do not administer ticagrelor tablets with another oral P2Y 12 platelet inhibitor.
  • Avoid aspirin at doses higher than recommended [see Clinical Studies ( 14.1 )].
  • 2.3 Coronary Artery Disease but No Prior Stroke or Myocardial Infarction Administer 60 mg of ticagrelor tablets twice daily.
  • Generally, use ticagrelor tablets with a daily maintenance dose of aspirin of 75 mg to 100 mg [see Clinical Studies ( 14 )] .
  • 2.4 Acute Ischemic Stroke or Transient Ischemic Attack (TIA) Initiate treatment with a 180 mg loading dose of ticagrelor tablets and then continue with 90 mg twice daily for up to 30 days.
  • Administer the first maintenance dose 6 to 12 hours after the loading dose.
  • Use ticagrelor tablets with a loading dose of aspirin (300 mg to 325 mg) and a daily maintenance dose of aspirin of 75 mg to 100 mg [see Clinical Studies ( 14 )] .
  • 2.4 Administration A patient who misses a dose of ticagrelor tablets should take one tablet (their next dose) at its scheduled time.
  • For patients who are unable to swallow tablets whole, ticagrelor tablets can be crushed, mixed with water and drunk.
  • The mixture can also be administered via a nasogastric tube (CH8 or greater) [see Clinical Pharmacology ( 12.3 )].
  • Do not administer ticagrelor tablets with another oral P2Y 12 platelet inhibitor.

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

Other warnings

  • Dyspnea was reported more frequently with ticagrelor than with control agents in clinical trials.
  • Dyspnea from ticagrelor is self-limiting.
  • ( 5.3 ) Severe Hepatic Impairment: Likely increase in exposure to ticagrelor.
  • ( 5.5 ) Laboratory Test Interference:
  • False negative platelet functional test results have been reported for Heparin Induced Thrombocytopenia (HIT).
  • Ticagrelor is not expected to impact PF4 antibody testing for HIT ( 5.7 ).
  • 5.1 Risk of Bleeding Drugs that inhibit platelet function including ticagrelor increase the risk of bleeding [see Warnings and Precautions ( 5.2 ) and Adverse Reactions ( 6.1 )] .
  • Patients treated for acute ischemic stroke or TIA Patients at NIHSS >5 and patients receiving thrombolysis were excluded from THALES and use of ticagrelor in such patients is not recommended.
  • 5.2 Discontinuation of Ticagrelor in Patients Treated for Coronary Artery Disease Discontinuation of ticagrelor will increase the risk of myocardial infarction, stroke, and death in patients being treated for coronary artery disease.
  • If ticagrelor must be temporarily discontinued (e.g., to treat bleeding or for significant surgery), restart it as soon as possible.
  • When possible, interrupt therapy with ticagrelor for five days prior to surgery that has a major risk of bleeding.
  • Resume ticagrelor as soon as hemostasis is achieved.
  • 5.3 Dyspnea In clinical trials, about 21% (THEMIS) of patients treated with ticagrelor developed dyspnea.
  • Dyspnea was usually mild to moderate in intensity and often resolved during continued treatment but led to study drug discontinuation in 1.0% (THALES) and 6.9% (THEMIS) of patients.
  • If a patient develops new, prolonged, or worsened dyspnea that is determined to be related to ticagrelor, no specific treatment is required; continue ticagrelor without interruption if possible.
  • In the case of intolerable dyspnea requiring discontinuation of ticagrelor, consider prescribing another antiplatelet agent.
  • 5.4 Bradyarrhythmias Ticagrelor can cause ventricular pauses [see Adverse Reactions ( 6.1 )] .
  • Bradyarrhythmias including AV block have been reported in the postmarketing setting.
  • Patients with a history of sick sinus syndrome, 2 nd or 3 rd degree AV block or bradycardia-related syncope not protected by a pacemaker were excluded from clinical studies and may be at increased risk of developing bradyarrhythmias with ticagrelor.
  • Severe Hepatic Impairment
  • Severe hepatic impairment is likely to increase serum concentration of ticagrelor.
  • There are no studies of ticagrelor patients with severe hepatic impairment [see Clinical Pharmacology ( 12.3 )] .
  • 5.6 Central Sleep Apnea Central sleep apnea (CSA) including Cheyne-Stokes respiration (CSR) has been reported in the post-marketing setting in patients taking ticagrelor, including recurrence or worsening of CSA/CSR following rechallenge.
  • If central sleep apnea is suspected, consider further clinical assessment.
  • 5.7 Laboratory Test Interferences False negative functional tests for Heparin Induced Thrombocytopenia (HIT) Ticagrelor has been reported to cause false negative results in platelet functional tests (including the heparin-induced platelet aggregation (HIPA) assay) for patients with Heparin Induced Thrombocytopenia (HIT).
  • This is related to inhibition of the P2Y 12 -receptor on the healthy donor platelets in the test by ticagrelor in the affected patient’s serum/plasma.
  • Information on concomitant treatment with ticagrelor is required for interpretation of HIT functional tests.
  • Based on the mechanism of ticagrelor interference, ticagrelor is not expected to impact PF4 antibody testing for HIT.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

  • Risk Summary Available data from case reports with ticagrelor use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
  • Ticagrelor given to pregnant rats and pregnant rabbits during organogenesis caused structural abnormalities in the offspring at maternal doses about 5 to 7 times the maximum recommended human dose (MRHD) based on body surface area.
  • When ticagrelor was given to rats during late gestation and lactation, pup death and effects on pup growth were seen at approximately 10 times the MRHD (see Data).
  • The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
  • All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
  • In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
  • Data Animal Data In reproductive toxicology studies, pregnant rats received ticagrelor during organogenesis at doses from 20 to 300 mg/kg/day. 20 mg/kg/day is approximately the same as the MRHD of 90 mg twice daily for a 60 kg human on a mg/m 2 basis.
  • Adverse outcomes in offspring occurred at doses of 300 mg/kg/day (16.5 times the MRHD on a mg/m 2 basis) and included supernumerary liver lobe and ribs, incomplete ossification of sternebrae, displaced articulation of pelvis, and misshapen/misaligned sternebrae.
  • At the mid-dose of 100 mg/kg/day (5.5 times the MRHD on a mg/m 2 basis), delayed development of liver and skeleton was seen.
  • When pregnant rabbits received ticagrelor during organogenesis at doses from 21 to 63 mg/kg/day, fetuses exposed to the highest maternal dose of 63 mg/kg/day (6.8 times the MRHD on a mg/m 2 basis) had delayed gall bladder development and incomplete ossification of the hyoid, pubis and sternebrae occurred.
  • In a prenatal/postnatal study, pregnant rats received ticagrelor at doses of 10 to 180 mg/kg/day during late gestation and lactation.
  • Pup death and effects on pup growth were observed at 180 mg/kg/day (approximately 10 times the MRHD on a mg/m 2 basis).
  • Relatively minor effects such as delays in pinna unfolding and eye opening occurred at doses of 10 and 60 mg/kg (approximately one-half and 3.2 times the MRHD on a mg/m 2 basis).
  • IN SPECIFIC POPULATIONS Lactation: Breastfeeding not recommended ( 8.2 )
  • 8.1 Pregnancy Risk Summary Available data from case reports with ticagrelor use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
  • Ticagrelor given to pregnant rats and pregnant rabbits during organogenesis caused structural abnormalities in the offspring at maternal doses about 5 to 7 times the maximum recommended human dose (MRHD) based on body surface area.
  • When ticagrelor was given to rats during late gestation and lactation, pup death and effects on pup growth were seen at approximately 10 times the MRHD (see Data).
  • The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
  • All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
  • In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
  • Data Animal Data In reproductive toxicology studies, pregnant rats received ticagrelor during organogenesis at doses from 20 to 300 mg/kg/day. 20 mg/kg/day is approximately the same as the MRHD of 90 mg twice daily for a 60 kg human on a mg/m 2 basis.
  • Adverse outcomes in offspring occurred at doses of 300 mg/kg/day (16.5 times the MRHD on a mg/m 2 basis) and included supernumerary liver lobe and ribs, incomplete ossification of sternebrae, displaced articulation of pelvis, and misshapen/misaligned sternebrae.
  • At the mid-dose of 100 mg/kg/day (5.5 times the MRHD on a mg/m 2 basis), delayed development of liver and skeleton was seen.
  • When pregnant rabbits received ticagrelor during organogenesis at doses from 21 to 63 mg/kg/day, fetuses exposed to the highest maternal dose of 63 mg/kg/day (6.8 times the MRHD on a mg/m 2 basis) had delayed gall bladder development and incomplete ossification of the hyoid, pubis and sternebrae occurred.
  • In a prenatal/postnatal study, pregnant rats received ticagrelor at doses of 10 to 180 mg/kg/day during late gestation and lactation.
  • Pup death and effects on pup growth were observed at 180 mg/kg/day (approximately 10 times the MRHD on a mg/m 2 basis).
  • Relatively minor effects such as delays in pinna unfolding and eye opening occurred at doses of 10 and 60 mg/kg (approximately one-half and 3.2 times the MRHD on a mg/m 2 basis).
  • 8.2 Lactation Risk Summary There are no data on the presence of ticagrelor or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production.
  • Ticagrelor and its metabolites were present in rat milk at higher concentrations than in maternal plasma.
  • When a drug is present in animal milk, it is likely that the drug will be present in human milk.
  • Breastfeeding is not recommended during treatment with ticagrelor.
  • 8.4 Pediatric Use The safety and effectiveness of ticagrelor have not been established in pediatric patients.
  • Pediatric use information describing a clinical study in which efficacy was not demonstrated is approved for AstraZeneca Pharmaceuticals LP’s BRILINTA® (ticagrelor) tablets.
  • However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights, this drug product is not labeled with that information.
  • 8.5 Geriatric Use About half of the patients in THEMIS and THALES were ≥65 years of age and at least 15% were ≥75 years of age.
  • No overall differences in safety or effectiveness were observed between elderly and younger patients.
  • 8.6 Hepatic Impairment Ticagrelor is metabolized by the liver and impaired hepatic function can increase risks for bleeding and other adverse events.
  • Avoid use of ticagrelor in patients with severe hepatic impairment.
  • There is limited experience with ticagrelor in patients with moderate hepatic impairment; consider the risks and benefits of treatment, noting the probable increase in exposure to ticagrelor.
  • No dosage adjustment is needed in patients with mild hepatic impairment [see Warnings and Precautions ( 5.5 ) and Clinical Pharmacology ( 12.3 )] .
  • 8.7 Renal Impairment No dosage adjustment is needed in patients with renal impairment [see Clinical Pharmacology ( 12.3 )] .
  • Patients with End-Stage Renal Disease on dialysis Clinical efficacy and safety studies with ticagrelor did not enroll patients with end-stage renal disease (ESRD) on dialysis.
  • In patients with ESRD maintained on intermittent hemodialysis, no clinically significant difference in concentrations of ticagrelor and its metabolite and platelet inhibition are expected compared to those observed in patients with normal renal function [see Clinical Pharmacology ( 12.3 )] .
  • It is not known whether these concentrations will lead to similar efficacy and safety in patients with ESRD on dialysis as were seen in THEMIS and THALES.

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

Other medicines

  • Avoid use with strong CYP3A inhibitors or CYP3A inducers.
  • ( 7.1 , 7.2 ) Opioids: Decreased exposure to ticagrelor.
  • Consider use of parenteral anti-platelet agent.
  • ( 7.3 ) Patients receiving more than 40 mg per day of simvastatin or lovastatin, or more than 20 mg per day of rosuvastatin may be at increased risk of statin-related adverse effects.
  • ( 7.4 ) Monitor digoxin levels with initiation of or any change in ticagrelor.
  • ( 7.5 )
  • 7.1 Strong CYP3A Inhibitors Strong CYP3A inhibitors substantially increase ticagrelor exposure and so increase the risk of dyspnea, bleeding, and other adverse events.
  • Avoid use of strong inhibitors of CYP3A (e.g., ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir and telithromycin) [see Clinical Pharmacology (12.3) ].
  • 7.2 Strong CYP3A Inducers Strong CYP3A inducers substantially reduce ticagrelor exposure and so decrease the efficacy of ticagrelor.
  • Avoid use with strong inducers of CYP3A (e.g., rifampin, phenytoin, carbamazepine and phenobarbital) [see Clinical Pharmacology (12.3) ].
  • 7.3 Opioids As with other oral P2Y 12 inhibitors, co-administration of opioid agonists delay and reduce the absorption of ticagrelor and its active metabolite presumably because of slowed gastric emptying [see Clinical Pharmacology (12.3) ]. .
  • Consider the use of a parenteral anti-platelet agent in acute coronary syndrome patients requiring co-administration of morphine or other opioid agonists.
  • 7.4 Simvastatin, Lovastatin, Rosuvastatin Ticagrelor increases serum concentrations of simvastatin and lovastatin because these drugs are metabolized by CYP3A4.
  • Avoid simvastatin and lovastatin doses greater than 40 mg [see Clinical Pharmacology ( 12.3 )] .
  • Ticagrelor increases serum concentration of rosuvastatin because rosuvastatin is a BCRP substrate.
  • Avoid rosuvastatin doses greater than 20 mg [see Clinical Pharmacology ( 12.3 )] .
  • In patients at increased risk for rhabdomyolysis, consider rosuvastatin dosages less than 20 mg per day.
  • 7.5 Digoxin Ticagrelor inhibits the P-glycoprotein transporter; monitor digoxin levels with initiation of or change in ticagrelor therapy [see Clinical Pharmacology ( 12.3 )].

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.

  • There is currently no known treatment to reverse the effects of ticagrelor, and ticagrelor is not dialyzable.
  • Treatment of overdose should follow local standard medical practice.
  • Bleeding is the expected pharmacologic effect of overdosing.
  • If bleeding occurs, appropriate supportive measures should be taken.
  • Platelet transfusion did not reverse the antiplatelet effect of ticagrelor in healthy volunteers and is unlikely to be of clinical benefit in patients with bleeding.
  • Other effects of overdose may include gastrointestinal effects (nausea, vomiting, diarrhea) or ventricular pauses.
  • Monitor the ECG.

Quoted from the official label, section “Overdosage”.

Use in children

  • The safety and effectiveness of ticagrelor have not been established in pediatric patients.
  • Pediatric use information describing a clinical study in which efficacy was not demonstrated is approved for AstraZeneca Pharmaceuticals LP’s BRILINTA® (ticagrelor) tablets.
  • However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights, this drug product is not labeled with that information.

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

Use in older people

About half of the patients in THEMIS and THALES were ≥65 years of age and at least 15% were ≥75 years of age. No overall differences in safety or effectiveness were observed between elderly and younger patients.

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

Side effects

  • The following adverse reactions are also discussed elsewhere in the labeling:
  • Bleeding [see Warnings and Precautions ( 5.1 )] Dyspnea [see Warnings and Precautions ( 5.3 )] Most common adverse reactions (>5%) are bleeding and dyspnea.
  • ( 5.1 , 5.3 , 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Hisun Pharmaceuticals USA, Inc. at 1-855-554-4786 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.
  • Ticagrelor has been evaluated for safety in more than 58,000 patients.
  • Bleeding in THEMIS (Prevention of major CV events in patients with CAD and Type 2 Diabetes Mellitus) The Kaplan-Meier curve of time to first TIMI Major bleeding event is presented in Figure 3.
  • Figure 3 - Time to first TIMI Major bleeding event (THEMIS) T = Ticagrelor;
  • P = Placebo;
  • N = Number of patients The bleeding events in THEMIS are shown below in Table 6.
  • Table 6 – Bleeding events (THEMIS) Ticagrelor N=9562 Placebo N=9531 Events / 1000 patient years Events / 1000 patient years TIMI Major 9 4 TIMI Major or Minor 12 5 TIMI Major or Minor or Requiring medical attention 46 18 Fatal bleeding 1 0 Intracranial hemorrhage 3 2 Bleeding in THALES (Reduction in risk of stroke in patients with acute ischemic stroke or TIA) The Kaplan-Meier curve of time course of GUSTO severe bleeding events is presented in Figure 4.
  • Figure 4 - Time course of GUSTO severe bleeding events KM%:
  • Kaplan-Meier percentage evaluated at Day 30;
  • T = Ticagrelor;
  • P = placebo;
  • N = Number of patients GUSTO Severe :
  • Any one of the following:
  • fatal bleeding, intracranial bleeding (excluding asymptomatic hemorrhagic transformations of ischemic brain infarctions and excluding microhemorrhages < 10 mm evident only on gradient-echo magnetic resonance imaging), bleeding that caused hemodynamic compromise requiring intervention (eg, systolic blood pressure <90 mmg Hg that required blood or fluid replacement, or vasopressor/inotropic support, or surgical intervention).
  • Intracranial bleeding and fatal bleeding in THALES:
  • In total, there were 21 intracranial hemorrhages (ICHs) for ticagrelor and 6 ICHs for placebo.
  • Fatal bleedings, almost all ICH, occurred in 11 for ticagrelor and in 2 for placebo.
  • Bradycardia THEMIS and THALES excluded patients at increased risk of bradycardic events (e.g., patients who have sick sinus syndrome, 2 nd or 3 rd degree AV block, or bradycardic-related syncope and not protected with a pacemaker). 15 16
  • 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of ticagrelor.
  • Because these reactions are reported voluntarily from a population of an unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
  • Blood and lymphatic system disorders:
  • Thrombotic Thrombocytopenic Purpura (TTP) has been rarely reported with the use of ticagrelor.
  • TTP is a serious condition which can occur after a brief exposure (<2 weeks) and requires prompt treatment.
  • Immune system disorders:
  • Hypersensitivity reactions including angioedema [see Contraindications ( 4.3 )].
  • Respiratory Disorders:
  • Central sleep apnea, Cheyne-Stokes respiration Skin and subcutaneous tissue disorders:
  • Rash

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) Advise patients daily doses of aspirin should not exceed 100 mg and to
  • avoid taking any other medications that contain aspirin.
  • Advise patients that they:
  • Will bleed and bruise more easily Will take longer than usual to stop bleeding Should report any unanticipated, prolonged or excessive bleeding, or blood in their stool or urine.
  • Advise patients to contact their doctor if they experience unexpected shortness of breath, especially if severe.
  • Advise patients to inform physicians and dentists that they are taking ticagrelor tablets before any surgery or dental procedure.
  • Advise women that breastfeeding is not recommended during treatment with ticagrelor [see Use in Specific Populations ( 8.2 )].
  • Distributed by: Hisun Pharmaceuticals USA, Inc.
  • Bridgewater, NJ 08807 Manufactured in China.
  • Revised: 07/2026

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

Strengths and forms

FORMS AND STRENGTHS Ticagrelor tablets 90 mg are supplied as a round, biconvex, yellow, film-coated tablet debossed with a “HU” on one side and “90” on the other side. 90 mg tablets ( 3 )

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

What it looks like and how it is packed

  • Ticagrelor tablets 90 mg are supplied as a round, biconvex, yellow, film-coated tablet debossed with “HU” on one side and “90” on the other side.
  • Bottles of 60 NDC 42658-115-03 Bottles of 180 NDC 42658-115-10 Bottles of 500 NDC 42658-115-07 Storage and Handling
  • Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].

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

What is in it

  • Ticagrelor tablets contain ticagrelor, a cyclopentyltriazolopyrimidine, inhibitor of platelet activation and aggregation mediated by the P2Y 12 ADP-receptor.
  • Chemically it is (1 S ,2 S ,3 R ,5 S )-3-[7-{[(1 R ,2 S )-2-(3,4-difluorophenyl)cyclopropyl]amino}-5-(propylthio)-3 H -[1,2,3]-triazolo[4,5- d ]pyrimidin-3-yl]-5-(2-hydroxyethoxy)cyclopentane-1,2-diol.
  • The empirical formula of ticagrelor is C 23 H 28 F 2 N 6 O 4 S and its molecular weight is 522.57.
  • The chemical structure of ticagrelor is:
  • Ticagrelor is a crystalline powder with an aqueous solubility of approximately 10 μg/mL at room temperature.
  • Ticagrelor 90 mg tablets for oral administration contain 90 mg of ticagrelor and the following ingredients:
  • microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, hypromellose E5, polyethylene glycol 4000, colloidal silicon dioxide, magnesium stearate, hypromellose 2910, titanium dioxide, polyethylene glycol 400, ferric oxide yellow, ferric oxide red, and ferrosoferric oxide. 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.

The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

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Details

Made byHisun Pharmaceuticals USA, Inc.
Active substanceTicagrelor
Used inBlood, clotting and anaemia
Strength90 mg
FormTablet, Film Coated
RouteOral
Packs60 TABLET, FILM COATED in 1 BOTTLE
NDC42658-115

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).

Other strengths and forms

51 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.