Medical Editor: John P. Cunha, DO, FACOEP
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:
- abnormal stools,
- fast or pounding heartbeats,
- swelling (edema),
- leg cramps,
- numbness or tingling,
- joint pain,
- runny or stuffy nose, and
Tell your doctor if you have serious side effects of Pletal including:
- severe headache
- bloody urine
- painful urination
- 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.
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.
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)
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- Patients with Heart Failure [see BOX WARNING]
- Tachycardia [see WARNINGS AND PRECAUTIONS]
- Left Ventricular Outflow Tract Obstruction [see WARNINGS AND PRECAUTIONS]
- Hematologic Adverse Reactions [see WARNINGS AND PRECAUTIONS]
- Hemostatic Disorders or Active Pathologic Bleeding [see WARNINGS AND PRECAUTIONS]
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)
|PLT 50 mg twice daily
|PLT 100 mg twice daily
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
Hematologic and Lymphatic: anemia
Metabolic and Nutritional: increased creatinine, hyperuricemia
Skin and Appendages: urticaria
Urogenital: urinary frequency
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
General Disorders And Administration Site Conditions
Pain, chest pain, hot flushes
Hepatic dysfunction/abnormal liver function tests, jaundice
Immune System Disorders
Nervous System Disorders
Renal And Urinary Disorders
Respiratory, Thoracic And Mediastinal Disorders
Pulmonary hemorrhage, interstitial pneumonia
Skin And Subcutaneous Tissue Disorders
Read the entire FDA prescribing information for Pletal (Cilostazol)
© 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.