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Adverse reactions in stroke patients were relatively frequent with over 50% of patients reporting at least one. Most (30% to 40%) involved the gastrointestinal tract. Most adverse effects are mild, but 21% of patients discontinued therapy because of an adverse event, principally diarrhea, rash, nausea, vomiting, GI pain and neutropenia. Most adverse effects occur early in the course of treatment, but a new onset of adverse effects can occur after several months.
The incidence rates of adverse events listed in the following table were derived from multicenter, controlled clinical trials in stroke patients described above comparing TICLID (ticlopidine hcl) , placebo and aspirin over study periods of up to 5.8 years. Adverse events considered by the investigator to be probably drug-related that occurred in at least 1% of patients treated with TICLID (ticlopidine hcl) are shown in the following table:
Percent of Patients With Adverse Events in Controlled Studies
(TASS and CATS)
|Event||TICLID (ticlopidine hcl)
(n = 2048)
(n = 1527)
(n = 536)
|Any Events||60.0 (20.9)||53.2 (14.5)||34.3 (6.1)|
|Diarrhea||12.5 (6.3)||5.2 (1.8)||4.5 (1.7)|
|Nausea||7.0 (2.6)||6.2 (1.9)||1.7 (0.9)|
|Dyspepsia||7.0 (1.1)||9.0 (2.0)||0.9 (0.2)|
|Rash||5.1 (3.4)||1.5 (0.8)||0.6 (0.9)|
|GI Pain||3.7 (1.9)||5.6 (2.7)||1.3 (0.4)|
|Neutropenia||2.4 (1.3)||0.8 (0.1)||1.1 (0.4)|
|Purpura||2.2 (0.2)||1.6 (0.1)||0.0 (0.0)|
|Vomiting||1.9 (1.4)||1.4 (0.9)||0.9 (0.4)|
|Flatulence||1.5 (0.1)||1.4 (0.3)||0.0 (0.0)|
|Pruritus||1.3 (0.8)||0.3 (0.1)||0.0 (0.0)|
|Dizziness||1.1 (0.4)||0.5 (0.4)||0.0 (0.0)|
|Anorexia||1.0 (0.4)||0.5 (0.3)||0.0 (0.0)|
|Abnormal Liver Function Test||1.0 (0.7)||0.3 (0.3)||0.0 (0.0)|
Incidence of discontinuation, regardless of relationship to therapy, is shown in parentheses.
Hematological: Neutropenia/thrombocytopenia, TTP, aplastic anemia (see BOXED WARNING and WARNINGS), leukemia, agranulocytosis, eosinophilia, pancytopenia, thrombocytosis and bone-marrow depression have been reported.
Gastrointestinal: TICLID (ticlopidine hcl) therapy has been associated with a variety of gastrointestinal complaints including diarrhea and nausea. The majority of cases are mild, but about 13% of patients discontinued therapy because of these. They usually occur within 3 months of initiation of therapy and typically are resolved within 1 to 2 weeks without discontinuation of therapy. If the effect is severe or persistent, therapy should be discontinued. In some cases of severe or bloody diarrhea, colitis was later diagnosed.
Hemorrhagic: TICLID (ticlopidine hcl) has been associated with increased bleeding, spontaneous posttraumatic bleeding and perioperative bleeding including, but not limited to, gastrointestinal bleeding. It has also been associated with a number of bleeding complications such as ecchymosis, epistaxis, hematuria and conjunctival hemorrhage.
Intracerebral bleeding was rare in clinical trials in stroke patients with TICLID (ticlopidine hcl) , with an incidence no greater than that seen with comparator agents (ticlopidine 0.5%, aspirin 0.6%, placebo 0.75%). It has also been reported postmarketing.
Rash: Ticlopidine has been associated with a maculopapular or urticarial rash (often with pruritus). Rash usually occurs within 3 months of initiation of therapy with a mean onset time of 11 days. If drug is discontinued, recovery occurs within several days. Many rashes do not recur on drug rechallenge. There have been rare reports of severe rashes, including Stevens-Johnson syndrome, erythema multiforme and exfoliative dermatitis.
Less Frequent Adverse Reactions (Probably Related): Clinical adverse experiences occurring in 0.5% to 1.0% of stroke patients in controlled trials include: Digestive System: GI fullness
Skin and Appendages: urticaria
Nervous System: headache
Body as a Whole: asthenia, pain
Hemostatic System: epistaxis
Special Senses: tinnitus
In addition, rarer, relatively serious and potentially fatal events associated with the use of TICLID (ticlopidine hcl) have also been reported from postmarketing experience: Hemolytic anemia with reticulocytosis, immune thrombocytopenia, hepatitis, hepatocellular jaundice, cholestatic jaundice, hepatic necrosis, hepatic failure, peptic ulcer, renal failure, nephrotic syndrome, hyponatremia, vasculitis, sepsis, allergic reactions (including angioedema, allergic pneumonitis, and anaphylaxis), systemic lupus (positive ANA), peripheral neuropathy, serum sickness, arthropathy and myositis.
Read the Ticlid (ticlopidine hcl) Side Effects Center for a complete guide to possible side effects
Therapeutic doses of TICLID (ticlopidine hcl) caused a 30% increase in the plasma half-life of antipyrine and may cause analogous effects on similarly metabolized drugs. Therefore, the dose of drugs metabolized by hepatic microsomal enzymes with low therapeutic ratios or being given to patients with hepatic impairment may require adjustment to maintain optimal therapeutic blood levels when starting or stopping concomitant therapy with ticlopidine. Studies of specific drug interactions yielded the following results:
Aspirin and Other NSAIDs: Ticlopidine potentiates the effect of aspirin or other NSAIDs on platelet aggregation. The safety of concomitant use of ticlopidine and NSAIDs has not been established. The safety of concomitantuse of ticlopidine and aspirin beyond 30 days has not been established (see Clinical Trials : Stent Patients). Aspirin did not modify the ticlopidine-mediated inhibition of ADP-induced platelet aggregation, but ticlopidine potentiated the effect of aspirin on collagen-induced platelet aggregation. Caution should be exercised in patients who have lesions with a propensity to bleed, such as ulcers. Long-term concomitant use of aspirin and ticlopidine is not recommended (see PRECAUTIONS: GI Bleeding).
Antacids: Administration of TICLID (ticlopidine hcl) after antacids resulted in an 18% decrease in plasma levels of ticlopidine.
Cimetidine: Chronic administration of cimetidine reduced the clearance of a single dose of TICLID (ticlopidine hcl) by 50%.
Digoxin: Coadministration of TICLID (ticlopidine hcl) with digoxin resulted in a slight decrease (approximately 15%) in digoxin plasma levels. Little or no change in therapeutic efficacy of digoxin would be expected.
Theophylline: In normal volunteers, concomitant administration of TICLID (ticlopidine hcl) resulted in a significant increase in the theophylline elimination half-life from 8.6 to 12.2 hours and a comparable reduction in total plasma clearance of theophylline.
Phenobarbital: In 6 normal volunteers, the inhibitory effects of TICLID (ticlopidine hcl) on platelet aggregation were not altered by chronic administration of phenobarbital.
Phenytoin: In vitro studies demonstrated that ticlopidine does not alter the plasma protein binding of phenytoin. However, the protein binding interactions of ticlopidine and its metabolites have not been studied in vivo. Several cases of elevated phenytoin plasma levels with associated somnolence and lethargy have been reported following coadministration with TICLID (ticlopidine hcl) . Caution should be exercised in coadministering this drug with TICLID (ticlopidine hcl) , and it may be useful to remeasure phenytoin blood concentrations.
Propranolol: In vitro studies demonstrated that ticlopidine does not alter the plasma protein binding of propranolol. However, the protein binding interactions of ticlopidine and its metabolites have not been studied in vivo. Caution should be exercised in coadministering this drug with TICLID (ticlopidine hcl) .
Other Concomitant Therapy: Although specific interaction studies were not performed, in clinical studies TICLID (ticlopidine hcl) was used concomitantly with beta blockers, calcium channel blockers and diuretics without evidence of clinically significant adverse interactions (see PRECAUTIONS).
Food Interaction: The oral bioavailability of ticlopidine is increased by 20% when taken after a meal. Administration of TICLID (ticlopidine hcl) with food is recommended to maximize gastrointestinal tolerance. In controlled trials in stroke patients, TICLID (ticlopidine hcl) was taken with meals.
Read the Ticlid Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 6/10/2008
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