Cilostazol Side Effects

Brand Names: Pletal

Please note - some side effects for Cilostazol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Cilostazol - for the Consumer

Cilostazol

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Cilostazol:

Abnormal stools; back pain; bloating or swelling of ankles, feet, or hands; diarrhea; dizziness; feeling of a whirling motion; gas; headache; increased cough; indigestion; infection; muscle aches; nausea; runny nose; sore throat; stomach pain; swelling of the legs and feet.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; fast or irregular heartbeat; pounding in the chest; unusual bruising or bleeding; vomiting material that looks like coffee grounds.

Cilostazol Side Effects - for the Professional

Cilostazol

Adverse events were assessed in eight placebo-controlled clinical trials involving 2274 patients exposed to either 50 or 100 mg b.i.d. Cilostazol (N=1301)or placebo (N=973), with a median treatment duration of 127 days for patients on Cilostazol and 134 days for patients on placebo.

The only adverse event resulting in discontinuation of therapy in ≥3% of patients treated with Cilostazol 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 Cilostazol 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 Cilostazol 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, hyperesthesia, 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 Cilostazol 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 hemorrhage.

Cardiovascular: Atrial fibrillation, atrial flutter, cerebral infarct, cerebral ischemia, congestive heart failure, heart arrest, hemorrhage, 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 hemorrhage, esophagitis, increased GGT, gastritis, gastroenteritis, gum hemorrhage, hematemesis, melena, peptic ulcer, periodontal abscess, rectal hemorrhage, 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 hemorrhage, retinal hemorrhage, tinnitus.

Urogenital: Albuminuria, cystitis, urinary frequency, vaginal hemorrhage, vaginitis.

Post-Marketing Experience

The following events have been reported spontaneously from worldwide post-marketing experience since the launch of Cilostazol in the US.

• Blood and Lymphatic System Disorders: Agranulocytosis, aplastic anemia, granulocytopenia, thrombocytopenia, leukopenia, bleeding tendency
• Cardiac Disorders: Torsades de pointes, QTc prolongation (torsades de pointes and QTc prolongation occurred in patients with cardiac disorders, e.g. complete atrioventricular block, cardiac failure and bradyarrythmia, when treated with Cilostazol. Cilostazol was used "off label" due to its positive chronotropic action)
• Gastrointestinal Disorders: Gastrointestinal hemorrhage
• General Disorders and Administration Site Conditions: Pain, chest pain, hot flushes
• Hepatobiliary Disorders: Hepatic dysfunction/abnormal liver function tests, jaundice
• Injury, Poisoning and Procedural Complications: Extradural hematoma and subdural hematoma
• Investigations: Blood glucose increased, blood uric acid increased, platelet count decreased, white blood cell count decreased, increase in BUN (blood urea increased), blood pressure increase
• Nervous System Disorders: Intracranial hemorrhage, cerebral hemorrhage, cerebrovascular accident
• Respiratory, Thoracic and Mediastinal Disorders: Pulmonary hemorrhage, interstitial pneumonia
• Skin and Subcutaneous Tissue Disorders: Hemorrhage subcutaneous, pruritus, skin eruptions including Stevens-Johnson syndrome, skin drug eruption (dermatitis medicamentosa)
• Vascular Disorders: Subacute thrombosis (these cases of subacute thrombosis occurred in patients treated with aspirin and "off label" use of Cilostazol for prevention of thrombotic complication after coronary stenting)

Side Effects by Body System

Nervous system

Nervous system side effects have commonly included headache (34%) resulting in discontinuation in 3.5% of patients. Dizziness (10%) and vertigo (2%) have also been reported. Other less frequently reported side effects have included asthenia, hyperesthesia, and paresthesia.

Cardiovascular

An increase in ventricular premature beats and nonsustained ventricular tachycardia has been seen in holter monitored patients. Cardiovascular damage including endocardial hemorrhage, left ventricular fibrosis, and necrosis of smooth muscle in coronary arteries has been demonstrated in dogs after 52 weeks of cilostazol administration.

In the AT-BAT study, one patient died during a bradycardic episode 46 hours after a successful PCI, another patient required surgical revascularization, and one patient experienced no reflow requiring a temporary intra-aortic balloon.

Cardiovascular side effects have included palpitations (10%) and tachycardia (4%). Peripheral edema has been reported in 7% of patients, and hypertension and angina pectoris have been reported in 2% of patients. Postmarketing reports have included chest pain, angina pectoris, hypertension, and hypotension.

Gastrointestinal

Gastrointestinal side effects have included diarrhea (19%), nausea (7%), dyspepsia (6%), abdominal pain (5%), flatulence (3%) and vomiting (2%).

Musculoskeletal

Musculoskeletal side effects have included back pain (7%), myalgia (3%), leg cramps (2%), and arthritis (2%).

Respiratory

Respiratory side effects have included pharyngitis (10%), rhinitis (7%), increased cough (4%), dyspnea (2%), and bronchitis (2%). Postmarketing reports have included pulmonary hemorrhage and interstitial pneumonia.

Dermatologic

Dermatologic side effects have included rash in 2% of patients. Postmarketing reports have included pruritus and skin eruptions including Stevens-Johnson syndrome.

Hematologic

In the AT-BAT study, one patient who did not undergo PCI had major bleeding during CABG on the day following angiography, nine patients had minor bleeding (mostly due to access site bleeding), and two patients developed moderate thrombocytopenia.

Hematologic side effects have included postmarketing reports of thrombocytopenia, aplastic anemia, leukopenia, and bleeding tendencies.

Hepatic

Hepatic side effects have included postmarketing reports of jaundice, hepatic dysfunction and abnormal liver function tests.

Renal

Renal side effects have included postmarketing reports of increased BUN and hematuria.

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