Prescription medication · PDE3 Inhibitor (Antiplatelet)
cilostazol
Also sold as Pletal. Cilostazol treats intermittent claudication.
- 5,992
- FDA reportsLightly reported
- 8
- InteractionsFew interactions
- $0.12
- Generic price (NADAC)
What the data shows
cilostazol (Pletal) is a prescription PDE3 Inhibitor (Antiplatelet), reported less often than most tracked drugs (5,992 FDA reports), with 8 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
cilostazol (Pletal) is a prescription PDE3 Inhibitor (Antiplatelet). Cilostazol treats intermittent claudication.
Cilostazol is a medicine that helps improve walking distance in people with leg pain due to poor circulation. It works by helping blood flow more easily through your blood vessels.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Generic Price
$0.12/unit
Generic Available
Yes (5 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Cilostazol treats intermittent claudication.
Common side effects
Headache, Diarrhea, Abnormal stools
Key warnings
You should not take cilostazol if you have heart failure.
The sections below are summarized in plain English from cilostazol's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Cilostazol is a phosphodiesterase III (PDE III) inhibitor. It works by relaxing the muscles in your blood vessels. This helps more blood flow to your legs and feet.
How to Take It
Take cilostazol 100 mg twice a day. Take it at least 30 minutes before or 2 hours after breakfast and dinner. You may notice improvement in 2 to 4 weeks, but it could take up to 3 months. If you don't feel better after 3 months, talk to your doctor.
This is a plain-language summary of cilostazol's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
It is not known if cilostazol is safe to take during pregnancy. Talk to your doctor if you are pregnant or plan to become pregnant. It is also not known if cilostazol passes into breast milk. You should not breastfeed while taking cilostazol.
This is a plain-language summary of cilostazol's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is close to your next dose, skip the missed dose and continue with your regular schedule.
This is a plain-language summary of cilostazol's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store cilostazol tablets at room temperature (between 59°F and 86°F).
Side Effects (from patient reports)
Based on 5,992 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for cilostazol, by number of reports
- Diarrhea
Diarrhea
302 reports
- Fall
Fall
231 reports
- Pneumonia (lung infection)
Pneumonia (lung infection)
230 reports
- Death
Death
217 reports
- Shortness of breath
Shortness of breath
209 reports
- Nausea
Nausea
207 reports
- Anemia (low red blood cells)
Anemia (low red blood cells)
191 reports
- Weakness
Weakness
185 reports
- Tiredness
Tiredness
182 reports
- Dizziness
Dizziness
181 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for cilostazol each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where cilostazol sits
cilostazol has more FDA adverse-event reports than 28% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is cilostazol; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 5,992 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
5,992
Reports Mentioning Death
956
16.0% of reports — not proof of cause
Hospitalization Reports
2,791
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DIARRHOEA | 302 |
| 2 | FALL | 231 |
| 3 | PNEUMONIA | 230 |
| 5 | DEATH | 217 |
| 6 | DYSPNOEA | 209 |
| 7 | NAUSEA | 207 |
| 9 | ANAEMIA | 191 |
| 10 | ASTHENIA | 185 |
| 11 | FATIGUE | 182 |
| 12 | DIZZINESS | 181 |
| 13 | VOMITING | 179 |
| 14 | PAIN IN EXTREMITY | 170 |
| 15 | PAIN | 159 |
| 16 | RENAL FAILURE | 159 |
| 17 | HEADACHE | 152 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
You should not take cilostazol if you have heart failure. This medicine can be harmful if you have heart failure.
Known Drug Interactions
Other Drugs Metabolized by CYP3A: Alfentanil Bromocriptine Cilostazol Methylprednisolone Vinblastine Phenobarbital St. John’s Wort Use With Caution There have been spontaneous or published reports of CYP3A based interactions of clarithromycin with alfentanil, methylprednisolone, cilostazol, bromocriptine, vinblastine, phenobarbital, and St.
Mechanism: Clarithromycin blocks a specific protein in your liver that normally breaks down cilostazol.
What to do: Use this combination with caution and report any unusual symptoms to your healthcare provider.
Inhibitors of CYP2C19 Coadministration with CYP2C19 inhibitors (e.g., omeprazole) increases systemic exposure of cilostazol active metabolites.
Mechanism: Omeprazole blocks a specific protein in the liver that normally breaks down cilostazol. This causes the active parts of the medicine to build up in your body.
What to do: Your doctor may need to lower your dose of cilostazol to prevent side effects.
Reduce cilostazol tablets dose ( 2.2 , 7.1 ) 7.1 Inhibitors of CYP3A4 or CYP2C19 Inhibitors of CYP3A4 Coadministration of strong (e.g., ketoconazole) and moderate (e.g., erythromycin, diltiazem and grapefruit juice) CYP3A4 inhibitors can increase exposure to cilostazol.
Mechanism: Diltiazem slows down the liver's ability to process cilostazol, which leads to higher amounts of the drug staying in your bloodstream. This increases the risk of side effects from cilostazol.
What to do: You should talk to your doctor about reducing your cilostazol dose when taking these medications together.
Reduce cilostazol tablets dose ( 2.2 , 7.1 ) 7.1 Inhibitors of CYP3A4 or CYP2C19 Inhibitors of CYP3A4 Coadministration of strong (e.g., ketoconazole) and moderate (e.g., erythromycin, diltiazem and grapefruit juice) CYP3A4 inhibitors can increase exposure to cilostazol.
Mechanism: Ketoconazole slows down how fast your body breaks down cilostazol. This causes the amount of cilostazol in your blood to increase.
What to do: Your doctor should reduce your dose of cilostazol while you are taking this combination.
Reduce cilostazol tablets dose ( 2.2 , 7.1 ) 7.1 Inhibitors of CYP3A4 or CYP2C19 Inhibitors of CYP3A4 Coadministration of strong (e.g., ketoconazole) and moderate (e.g., erythromycin, diltiazem and grapefruit juice) CYP3A4 inhibitors can increase exposure to cilostazol.
Mechanism: Erythromycin interferes with the way your body processes cilostazol. This leads to higher levels of cilostazol in your system.
What to do: You will likely need a lower dose of cilostazol if you are also taking erythromycin.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
Can I take cilostazol with food?
How long does it take for cilostazol to work?
What should I do if I have side effects?
Can I drink grapefruit juice while taking cilostazol?
What if I am taking other medications?
Can cilostazol cause bleeding problems?
What if I need surgery?
Can I drive or operate machinery while taking cilostazol?
What should I do if my leg pain gets worse?
Is cilostazol a blood thinner?
What are the common side effects of cilostazol?
Does cilostazol interact with other medications?
What drug class is cilostazol?
Is cilostazol safe during pregnancy?
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Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for cilostazol
The FDA label for cilostazol (sold under brand names such as Pletal) classifies it as a prescription-only medication in the PDE3 Inhibitor (Antiplatelet) class. Cilostazol treats intermittent claudication. Official labeling lists 12 commonly reported side effects, including Headache, Diarrhea, Abnormal stools.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 5,992 voluntary reports. The database also lists 8 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $0.12.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: April 4, 2024
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages