March 27, 2017
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Pletal

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Pletal




Pletal Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 9/21/2016

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:

  • headache,
  • diarrhea,
  • vomiting,
  • abnormal stools,
  • dizziness,
  • weakness,
  • fast or pounding heartbeats,
  • palpitations,
  • swelling (edema),
  • leg cramps,
  • numbness or tingling,
  • joint pain,
  • cough,
  • runny or stuffy nose, 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. 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.

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

SIDE EFFECTS: Headache, diarrhea, runny nose, and dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

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 right away if you have any serious side effects, including: swelling hands/feet, easy bruising/bleeding, black/bloody stools, vomit that looks like coffee grounds, signs of infection (such as fever, persistent sore throat).

Get medical help right away if you have any very serious side effects, including: chest/jaw/left arm pain, fainting, fast/pounding/irregular heartbeat, severe dizziness, 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 Reactions)

SIDE EFFECTS

The following adverse reactions are discussed in greater detail inother 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)

Pletal - User Reviews

Pletal User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Pletal sorted by most helpful. Patient Discussions FAQs

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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