Pletal Side Effects

Generic Name: Cilostazol

Please note - some side effects for Pletal 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 Pletal - for the consumer

Pletal

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 Pletal:

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.

For the professional

Pletal

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.

Post-Marketing Experience

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

• Blood and lymphatic system disorders:

   

  - Agranulocytosis, 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 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

• Investigations:

   

  - Blood glucose increased, blood uric acid increased, platelet count decreased, white blood cell count decreased, increase in BUN (blood urea increased)

• 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:

   

  - 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.)

More resources:

Pletal

Pletal

Pletal - Includes detailed dosage instructions.

Pletal

Cilostazol

Cilostazol

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.