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Pletal

Pletal (Cilostazol) side effects drug center

 

PROFESSIONAL

CONSUMER

SIDE EFFECTS

Pletal Side Effects Center

Pletal (cilostazol) is a quinolinone derivative used for treatment of intermittent claudication and peripheral vascular disease. Generic formulations of Pletal are available. Side effects of Pletal include:

Tell your doctor if you have serious side effects of Pletal including:

  • severe headache
  • bloody urine
  • painful urination
  • fever
  • body aches
  • flu symptoms
  • chest pain
  • shortness of beath, even with mild exertion
  • swelling of your hands, ankles or feet
  • easy bruising or bleeding
  • black or bloody stools
  • vomit that looks like coffee grounds, or
  • signs of infection (such as fever, persistent sore throat)

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. Pletal may interact with clopidogrel, omeprazole, esomeprazole, erythromycin, clarithromycin, ketoconazole, fluconazole, itraconazole, diltiazem, fluvoxamine, fluoxetine, sertraline, or nefazodone. Tell your doctor if you are pregnant or plan to become pregnant during treatment with Pletal; it may harm a fetus. Pletal passes into breast milk and may harm a nursing baby. Consult your doctor before breastfeeding.

Our Pletal (cilostazol) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Pletal Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • chest pain, pounding heartbeats or fluttering in your chest;
  • a light-headed feeling, like you might pass out;
  • fever, chills, sore throat, mouth sores; or
  • easy bruising, unusual bleeding, purple or red spots under your skin.

Common side effects may include:

  • diarrhea, abnormal bowel movements;
  • headache; or
  • fast or pounding heartbeats.

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.

Read the entire detailed patient monograph for Pletal (Cilostazol)

 

Pletal Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adverse reactions were assessed in eight placebo-controlled clinical trials involving 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 most frequent adverse reaction resulting in discontinuation of therapy in more than 3% of patients treated with PLETAL was headache [50 mg twice daily (1.3%), 100 mg twice daily (3.5%) and placebo (0.3%)]. Other frequent causes of discontinuation included palpitation and diarrhea, both 1.1% for PLETAL (all doses) versus 0.1% for placebo.

The most common adverse reactions, occurring in at least 2% of patients treated with PLETAL 50 or 100 mg twice daily, are shown in Table 1.

Table 1: Most Common Adverse Reactions in Patients on PLETAL (PLT) 50 or 100 mg Twice Daily (Incidence at least 2% and Occurring More Frequently (≥ 2%) in the 100 mg Twice Daily Group than on Placebo)

Adverse Reactions Placebo
(N=973)		 PLT 50 mg twice daily
(N=303)		 PLT 100 mg twice daily
(N=998)
Headache 14% 27% 34%
Diarrhea 7% 12% 19%
Abnormal stools 4% 12% 15%
Palpitation 1% 5% 10%
Dizziness 6% 9% 10%
Pharyngitis 7% 7% 10%
Infection 8% 14% 10%
Peripheral edema 4% 9% 7%
Rhinitis 5% 12% 7%
Dyspepsia 4% 6% 6%
Abdominal pain 3% 4% 5%
Tachycardia 1% 4% 4%

Less frequent clinical significant adverse reactions (less than 2%) that were experienced by patients treated with 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 are listed below.

Body as a whole: fever, generalized edema, malaise

Cardiovascular: atrial fibrillation, heart failure, myocardial infarction, nodal arrhythmia, supraventricular tachycardia, ventricular extrasystoles, ventricular tachycardia

Digestive: anorexia, melena

Hematologic and Lymphatic: anemia

Metabolic and Nutritional: increased creatinine, hyperuricemia

Nervous: insomnia

Respiratory: epistaxis

Skin and Appendages: urticaria

Special Senses: conjunctivitis, retinal hemorrhage, tinnitus

Urogenital: urinary frequency

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of PLETAL. Because these reactions are reported voluntarily from a population of an unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood And Lymphatic System Disorders

Aplastic anemia, granulocytopenia, pancytopenia, bleeding tendency

Cardiac Disorders

Torsade de pointes and QTc prolongation in patients with cardiac disorders (e.g. complete atrioventricular block, heart failure; and bradyarrythmia), angina pectoris.

Gastrointestinal Disorders

Gastrointestinal hemorrhage, vomiting, flatulence, nausea

General Disorders And Administration Site Conditions

Pain, chest pain, hot flushes

Hepatobiliary Disorders

Hepatic dysfunction/abnormal liver function tests, jaundice

Immune System Disorders

Anaphylaxis, angioedema, and hypersensitivity

Investigations

Blood glucose increased, blood uric acid increased, increase in BUN (blood urea increased), blood pressure increase

Nervous System Disorders

Intracranial hemorrhage, cerebral hemorrhage, cerebrovascular accident, extradural hematoma and subdural hematoma

Renal And Urinary Disorders

Hematuria

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), rash.

Vascular Disorders

Subacute stent thrombosis, hypertension.

Read the entire FDA prescribing information for Pletal (Cilostazol)

&Copy; Pletal Patient Information is supplied by Cerner Multum, Inc. and Pletal Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.