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| __NOTOC__
| | #REDIRECT [[Ticlopidine#Adverse Reactions]] |
| {{Ticlopidine}}
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| {{CMG}}; {{AE}} {{AZ}}
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| ==Adverse Reactions==
| | [[Category: Cardiovascular Drugs]] |
| 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.
| | [[Category: Drug]] |
| | | [[Category:Antiplatelet drugs]] |
| The incidence rates of adverse events listed in the following table were derived from multicenter, controlled clinical trials in stroke patients described above comparing ticlopidine, 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 ticlopidine are shown in the following table:
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| |[[File:Ticlopedine Adverse in trails.JPG|600px|thumb]]
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| Incidence of discontinuation, regardless of relationship to therapy, is shown in parentheses.
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| ===Hematological===
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| [[Neutropenia]]/[[thrombocytopenia]], [[TTP]], [[aplastic anemia]] (see BOXED WARNING and WARNINGS), [[leukemia]], [[agranulocytosis]], [[eosinophilia]], [[pancytopenia]], [[thrombocytosis]] and bone-marrow depression have been reported. | |
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| ===Gastrointestinal===
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| Ticlopidine 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.
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| ===Hemorrhagic===
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| Ticlopidine 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]].
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| [[Intracranial hemorrhage overview|Intracerebral bleeding]] was rare in clinical trials in stroke patients with Ticlopidine, 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.
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| ===Rash===
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| 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]].
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| '''Less Frequent Adverse Reactions''' (Probably Related)
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| Clinical adverse experiences occurring in 0.5% to 1.0% of stroke patients in controlled trials include:
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| ===Digestive System===
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| GI fullness
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| ===Skin and Appendages===
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| [[Urticaria]]
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| ===Nervous System===
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| [[Headache]]
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| ===Body as a Whole===
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| [[Asthenia]], [[pain]]
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| ===Hemostatic System===
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| [[Epistaxis]]
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| ===Special Senses===
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| [[Tinnitus]]
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| In addition, rarer, relatively serious and potentially fatal events associated with the use of ticlopidine 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]].<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = TICLOPIDINE HYDROCHLORIDE TABLET, FILM COATED [APOTEX CORP.] | url =http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=707127cb-cdcd-81b0-274d-3c11fefa6824 | publisher = | date = | accessdate = }}</ref>
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| ==References==
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| {{Reflist}}
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| {{FDA}}
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| [[Category:Drugs]] | |