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Pletal Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Pletal (cilostazol) is used for treatment of internittent claudication and peripheral vascular disease. Generic formulations are available. Side effects include headache, diarrhea, abnormal stools, dizziness, palpitations, edema, and infections.
The usual dose is 100 mg twice daily 30 minutes before or 2 hours after a meal. It should not be used by patients with heart failure. Erythromycin, omeprazole, diltiazem, ketoconazole, itraconazole, fluconazole, and several other drugs increase blood levels of cilostazol. Use in pregnancy and during breast feeding has not been adequately evaluated.
Our Pletal (cilostazol) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Pletal in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- severe headache;
- bloody urine, painful urination;
- fever, chills, body aches, flu symptoms;
- chest pain;
- feeling short of breath, even with mild exertion; or
- swelling of your ankles or feet.
Less serious side effects may include:
- fast or pounding heartbeats;
- diarrhea, vomiting;
- weakness, dizziness;
- leg cramps;
- numbness or tingling;
- joint pain; or
- cough, runny or stuffy nose.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Pletal (Cilostazol)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Pletal Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these serious side effects occur: fast/pounding/irregular heartbeat, swelling of the hands/feet.
Tell your doctor immediately if any of these unlikely but serious side effects occur: easy bruising/bleeding, black or bloody stools, vomit that looks like coffee grounds, signs of infection (such as fever, persistent sore throat).
Get medical help right away if any of these rare but serious side effects occur: chest/jaw/left arm pain, fainting, vision changes, weakness on one side of the body, slurred speech, confusion.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Pletal (Cilostazol)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Pletal FDA Prescribing Information: Side Effects
Adverse events were assessed in eight placebo-controlled clinical trials involving 2274 patients exposed to either 50 or 100 mg twice daily 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 twice daily was headache, which occurred with an incidence of 1.3%, 3.5%, and 0.3% in patients treated with PLETAL 50 mg twice daily, 100 mg twice daily, 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 twice daily, and with a frequency higher than placebo, 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 twice daily group were: asthenia, hypertension, vomiting, leg cramps, hypesthesia, paresthesia, dyspnea, rash, hematuria, urinary tract infection, flu syndrome, angina pectoris, arthritis, and bronchitis.
Most Commonly Reported AEs (Incidence ≥ 2%) in
Patients on PLETAL (PLT) 50 mg twice daily or 100 mg twice daily and Occurring
at a Rate in the 100 mg twice daily Group Higher Than in Patients on Placebo
|Adverse Events (AEs) by Body System||PLT 50 mg twice daily
|PLT 100 mg twice daily
|BODY AS A WHOLE|
|METABOLIC & NUTRITIONAL|
Less frequent adverse events ( < 2%) that were experienced by patients exposed to PLETAL 50 mg twice daily or 100 mg twice daily in the eight controlled clinical trials and that occurred at a frequency in the 100 mg twice daily 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.
Metabolic and Nutritional: Increased creatinine, gout, hyperlipemia, hyperuricemia.
Musculoskeletal: Arthralgia, bone pain, bursitis.
Nervous: Anxiety, insomnia, neuralgia.
Skin and Appendages: Dry skin, furunculosis, skin hypertrophy, urticaria.
Urogenital: Albuminuria, cystitis, urinary frequency, vaginal haemorrhage, vaginitis.
The following adverse drug reactions (ADRs) to PLETAL have been reported worldwide since the launch of PLETAL in the US.
- Blood and lymphatic system disorders:
- Agranulocytosis, aplastic anemia, granulocytopenia, pancytopenia, 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 haemorrhage
- 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 haematoma and subdural haematoma
- 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 haemorrhage, cerebral haemorrhage, cerebrovascular accident
- Respiratory, thoracic and mediastinal disorders
- Pulmonary haemorrhage, interstitial pneumonia
- Skin and subcutaneous tissue disorders
- Haemorrhage subcutaneous, pruritus, skin eruptions including Stevens-Johnson syndrome, skin drug eruption (dermatitis medicamentosa)
- Vascular disorders
Read the entire FDA prescribing information for Pletal (Cilostazol)
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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