Cilostazol adverse reactions: Difference between revisions
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ADVERSE REACTIONS | |||
Adverse events were assessed in eight placebo-controlled clinical trials involving 2274 patients exposed to either 50 or 100 mg b.i.d. PLETAL (n=1301) or placebo (n=973), with a median treatment duration of 127 days for patients on PLETAL and 134 days for patients on placebo. | |||
The only adverse event resulting in discontinuation of therapy in ≥3% of patients treated with PLETAL 50 or 100 mg b.i.d. was headache, which occurred with an incidence of 1.3%, 3.5%, and 0.3% in patients treated with PLETAL 50 mg b.i.d., 100 mg b.i.d, or placebo, respectively. Other frequent causes of discontinuation included palpitation and diarrhea, both 1.1% for cilostazol (all doses) versus 0.1% for placebo. | |||
The most commonly reported adverse events, occurring in ≥2% of patients treated with PLETAL 50 or 100 mg b.i.d., are shown in the table (below). | |||
Other events seen with an incidence of ≥2%, but occurring in the placebo group at least as frequently as in the 100 mg b.i.d. group were: asthenia, hypertension, vomiting, leg cramps, hypesthesia, paresthesia, dyspnea, rash, hematuria, urinary tract infection, flu syndrome, angina pectoris, arthritis, and bronchitis. | |||
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Less frequent adverse events (<2%) that were experienced by patients exposed to PLETAL 50 mg b.i.d. or 100 mg b.i.d. in the eight controlled clinical trials and that occurred at a frequency in the 100 mg b.i.d. group greater than in the placebo group, regardless of suspected drug relationship, are listed below. | |||
Body as a whole: Chills, face edema, fever, generalized edema, malaise, neck rigidity, pelvic pain, retroperitoneal haemorrhage. | |||
Cardiovascular: Atrial fibrillation, atrial flutter, cerebral infarct, cerebral ischemia, congestive heart failure, heart arrest, haemorrhage, hypotension, myocardial infarction, myocardial ischemia, nodal arrhythmia, postural hypotension, supraventricular tachycardia, syncope, varicose vein, vasodilation, ventricular extrasystoles, ventricular tachycardia. | |||
Digestive: Anorexia, cholelithiasis, colitis, duodenal ulcer, duodenitis, esophageal haemorrhage, esophagitis, increased GGT, gastritis, gastroenteritis, gum haemorrhage, hematemesis, melena, peptic ulcer, periodontal abscess, rectal haemorrhage, stomach ulcer, tongue edema. | |||
Endocrine: Diabetes mellitus. | |||
Hemic and Lymphatic: Anemia, ecchymosis, iron deficiency anemia, polycythemia, purpura. | |||
Metabolic and Nutritional: Increased creatinine, gout, hyperlipemia, hyperuricemia. | |||
Musculoskeletal: Arthralgia, bone pain, bursitis. | |||
Nervous: Anxiety, insomnia, neuralgia. | |||
Respiratory: Asthma, epistaxis, hemoptysis, pneumonia, sinusitis. | |||
Skin and Appendages: Dry skin, furunculosis, skin hypertrophy, urticaria. | |||
Special Senses: Amblyopia, blindness, conjunctivitis, diplopia, ear pain, eye haemorrhage, retinal haemorrhage, tinnitus. | |||
Urogenital: Albuminuria, cystitis, urinary frequency, vaginal haemorrhage, vaginitis.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = PLETAL (CILOSTAZOL) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.] | url =http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=24d75b58-bafb-4440-b8d7-4f4079c08b0b | publisher = | date = | accessdate = }}</ref> | |||
==References== | ==References== | ||
{{Reflist}} | {{Reflist}} | ||
Revision as of 22:24, 30 January 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ahmed Zaghw, M.D. [2]
ADVERSE REACTIONS
Adverse events were assessed in eight placebo-controlled clinical trials involving 2274 patients exposed to either 50 or 100 mg b.i.d. PLETAL (n=1301) or placebo (n=973), with a median treatment duration of 127 days for patients on PLETAL and 134 days for patients on placebo.
The only adverse event resulting in discontinuation of therapy in ≥3% of patients treated with PLETAL 50 or 100 mg b.i.d. was headache, which occurred with an incidence of 1.3%, 3.5%, and 0.3% in patients treated with PLETAL 50 mg b.i.d., 100 mg b.i.d, or placebo, respectively. Other frequent causes of discontinuation included palpitation and diarrhea, both 1.1% for cilostazol (all doses) versus 0.1% for placebo.
The most commonly reported adverse events, occurring in ≥2% of patients treated with PLETAL 50 or 100 mg b.i.d., are shown in the table (below).
Other events seen with an incidence of ≥2%, but occurring in the placebo group at least as frequently as in the 100 mg b.i.d. group were: asthenia, hypertension, vomiting, leg cramps, hypesthesia, paresthesia, dyspnea, rash, hematuria, urinary tract infection, flu syndrome, angina pectoris, arthritis, and bronchitis.
 |
Less frequent adverse events (<2%) that were experienced by patients exposed to PLETAL 50 mg b.i.d. or 100 mg b.i.d. in the eight controlled clinical trials and that occurred at a frequency in the 100 mg b.i.d. group greater than in the placebo group, regardless of suspected drug relationship, are listed below.
Body as a whole: Chills, face edema, fever, generalized edema, malaise, neck rigidity, pelvic pain, retroperitoneal haemorrhage.
Cardiovascular: Atrial fibrillation, atrial flutter, cerebral infarct, cerebral ischemia, congestive heart failure, heart arrest, haemorrhage, hypotension, myocardial infarction, myocardial ischemia, nodal arrhythmia, postural hypotension, supraventricular tachycardia, syncope, varicose vein, vasodilation, ventricular extrasystoles, ventricular tachycardia.
Digestive: Anorexia, cholelithiasis, colitis, duodenal ulcer, duodenitis, esophageal haemorrhage, esophagitis, increased GGT, gastritis, gastroenteritis, gum haemorrhage, hematemesis, melena, peptic ulcer, periodontal abscess, rectal haemorrhage, stomach ulcer, tongue edema.
Endocrine: Diabetes mellitus.
Hemic and Lymphatic: Anemia, ecchymosis, iron deficiency anemia, polycythemia, purpura.
Metabolic and Nutritional: Increased creatinine, gout, hyperlipemia, hyperuricemia.
Musculoskeletal: Arthralgia, bone pain, bursitis.
Nervous: Anxiety, insomnia, neuralgia.
Respiratory: Asthma, epistaxis, hemoptysis, pneumonia, sinusitis.
Skin and Appendages: Dry skin, furunculosis, skin hypertrophy, urticaria.
Special Senses: Amblyopia, blindness, conjunctivitis, diplopia, ear pain, eye haemorrhage, retinal haemorrhage, tinnitus.
Urogenital: Albuminuria, cystitis, urinary frequency, vaginal haemorrhage, vaginitis.[1]
References
Adapted from the FDA Package Insert.