Cilostazol
Cilostazol is an oral medicine that eases the leg pain of intermittent claudication (pain when walking caused by poor blood flow) so people can walk farther.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 11 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Cilostazol (Pletal) treats intermittent claudication, the leg pain or cramping that comes on with walking and eases with rest, by keeping platelets (clotting cells) from clumping and helping blood vessels relax and widen; it is usually the first medicine tried for this, on the market since about 2001 and available as a generic. Headache, loose stools or diarrhea, and a pounding or racing heartbeat are the side effects people notice most, and a common reason some stop it early. Its boxed warning, the FDA’s strongest, rules it out for anyone with heart failure of any severity, so report new shortness of breath or swelling right away.
Clinical pearls
- Take it at least 30 minutes before or 2 hours after breakfast and dinner, not with meals.
- Benefit can take up to 12 weeks to show; if walking hasn’t improved by 3 months, your prescriber may stop it.
- Skip grapefruit juice, and flag omeprazole, fluconazole, erythromycin or diltiazem, which raise cilostazol levels and may call for a lower dose.
- Taking it with aspirin adds to the antiplatelet effect, so report black or bloody stools, blood in urine or easy bruising.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Do not take cilostazol if you have heart failure of any severity. Cilostazol belongs to a drug group (PDE III inhibitors). Other drugs in this group have been linked to shorter survival in people with moderate to severe heart failure.
If you have heart failure, tell your doctor before starting. If you develop new swelling or shortness of breath while taking it, call your doctor right away.
Patient information guide A plain-language walkthrough of Cilostazol, written from its FDA label.
What Cilostazol is used for
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Cilostazol is used for one main condition.
- Cilostazol tablets (oral) reduce symptoms of intermittent claudication, shown by an increase in walking distance.
How Cilostazol works
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Cilostazol and some of its breakdown products block phosphodiesterase III. This raises cAMP, a messenger chemical, in platelets and blood vessels. Platelets become less likely to clump together, and blood vessels widen (vasodilation).
The widening is stronger in leg arteries than in some other vessels, which fits its use for leg symptoms.
Cilostazol dosage
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Cilostazol tablets are taken by mouth twice a day. Take them at least 30 minutes before or 2 hours after breakfast and dinner.
- Benefit may start in 2 to 4 weeks but can take up to 12 weeks.
- If you haven't improved after 3 months, your prescriber may stop it.
- Your dose may be lowered if you take certain interacting medicines.
Follow your prescriber's directions and your label.
Dosing details from the FDA-approved label
From the Cilostazol prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Recommended dosage (cilostazol tablets)
- 100 mg twice daily taken at least half an hour before or two hours after breakfast and dinner
- Patients may respond as early as 2 to 4 weeks after the initiation of therapy, but treatment for up to 12 weeks may be needed; if symptoms are unimproved after 3 months, discontinue
- Coadministration with strong or moderate inhibitors of CYP3A4 or inhibitors of CYP2C19
- Reduce dose to 50 mg twice daily
- Applies with CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, erythromycin, diltiazem) or CYP2C19 inhibitors (e.g., ticlopidine, fluconazole, omeprazole)
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION The recommended dosage of cilostazol tablets is 100 mg twice daily taken at least half an hour before or two hours after breakfast and dinner ( 2.1 ) Reduce the dose to 50 mg twice daily when coadministered with CYP3A4 inhibitors such as ketoconazole, itraconazole, erythromycin, and diltiazem, or CYP2C19 inhibitors such as ticlopidine, fluconazole, and omeprazole ( 2.2 ) 2.1 Recommended Dosage The recommended dosage of cilostazol tablets is 100 mg twice daily taken at least half an hour before or two hours after breakfast and dinner. Patients may respond as early as 2 to 4 weeks after the initiation of therapy, but treatment for up to 12 weeks may be needed before a beneficial effect is experienced. If symptoms are unimproved after 3 months, discontinue cilostazol tablets. 2.2 Dose Reduction with CYP3A4 and CYP2C19 Inhibitors Reduce dose to 50 mg twice daily when coadministered with strong or moderate inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, erythromycin, and diltiazem) or inhibitors of CYP2C19 (e.g., ticlopidine, fluconazole, and omeprazole) [see Drug Interactions ( 7.1 )] .
Read the full Dosage and Administration section on DailyMed →
Cilostazol side effects
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Most side effects are mild to moderate and often involve the head, gut or heart rate.
Common side effects
- Headache
- Diarrhea
- Abnormal stools
- Palpitations (feeling your heart pound or flutter)
- Dizziness
- Fast heartbeat
- Swelling in the legs or feet (peripheral edema)
- Sore throat, runny nose or infection
- Indigestion and abdominal pain
When to get medical help
- Call your doctor right away if you have signs of heart failure, such as new shortness of breath or swelling.
- Get help for chest pain, a racing or irregular heartbeat, or fainting.
- Report any unusual bleeding, black or bloody stools, blood in urine, or a severe headache.
- Call your doctor about fever, sore throat or easy bruising, which could signal low blood cell counts.
- Get emergency help for signs of a serious allergic reaction, such as swelling of the face or throat, hives or trouble breathing.
- Report yellowing of the skin or eyes, or a severe skin rash.
Cilostazol warnings and precautions
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- Heart failure: cilostazol must not be used in heart failure of any severity (boxed warning).
- It can cause fast heartbeat, palpitations and low blood pressure.
- It may worsen angina or trigger a heart attack in people with ischemic heart disease.
- Left ventricular outflow tract obstruction has been reported. Report any new heart symptoms.
- Low platelet or white blood cell counts, rarely progressing to agranulocytosis (a severe drop in infection-fighting cells), have been reported. Blood counts are checked periodically.
- Avoid it with bleeding disorders or active bleeding.
Cilostazol interactions
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Some medicines and foods raise cilostazol levels, so the dose may need to be lowered.
- Ketoconazole, itraconazole, erythromycin, diltiazem and grapefruit juice (CYP3A4 blockers) increase cilostazol exposure.
- Omeprazole, fluconazole and ticlopidine (CYP2C19 blockers) raise levels of its active breakdown products.
- Aspirin increases the effect on platelets, though trials showed no clear rise in bleeding.
- Smoking lowers cilostazol exposure by about 20%.
Interactions listed in the FDA-approved label
From the Cilostazol prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Strong CYP3A4 inhibitors (e.g., ketoconazole): Can increase exposure to cilostazol. Reduce cilostazol dose to 50 mg twice daily.
- Moderate CYP3A4 inhibitors (e.g., erythromycin, diltiazem and grapefruit juice): Can increase exposure to cilostazol. Reduce cilostazol dose to 50 mg twice daily.
- CYP2C19 inhibitors (e.g., omeprazole): Increases systemic exposure of cilostazol active metabolites. Reduce cilostazol dose to 50 mg twice daily when coadministered with strong or moderate inhibitors of CYP2C19.
Read the label’s full interactions text
7 DRUG INTERACTIONS Strong and moderate CYP3A4 and CYP2C19 inhibitors: Increase exposure to cilostazol. 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. Reduce cilostazol dose to 50 mg twice daily when coadministered with strong or moderate inhibitors of CYP3A4 [see Dosage and Administration ( 2.2 ) and Clinical Pharmacology ( 12.3 )]. Inhibitors of CYP2C19 Coadministration with CYP2C19 inhibitors (e.g., omeprazole) increases systemic exposure of cilostazol active metabolites. Reduce cilostazol dose to 50 mg twice daily when coadministered with strong or moderate inhibitors of CYP2C19 [see Dosage and Administration ( 2.2 ) and Clinical Pharmacology ( 12.3 )].
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Cilostazol
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- Heart failure of any severity: do not take it.
- Allergy to cilostazol or its ingredients: do not take it.
- Heart disease history, bleeding disorders or active bleeding: tell your doctor first.
- Pregnancy: animal studies showed harm, and there are no adequate human studies.
- Breastfeeding: you may need to stop nursing or stop the drug.
- Children: safety and effectiveness have not been established.
- Older adults: no overall differences in safety or effectiveness were seen, though some may be more sensitive.
- Kidney problems: no dose change is needed. Mild liver problems: no dose change. Moderate or severe liver problems: not studied.
Cilostazol overdose
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An overdose would likely cause severe headache, diarrhea, low blood pressure, fast heartbeat and possibly irregular heart rhythms. Care is supportive, with close observation. Dialysis is unlikely to remove it.
What Cilostazol does in the body
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Cilostazol reduces platelet clumping in a dose-dependent way. Effects start within about 3 hours and last up to 12 hours after a single dose. After stopping, effects fade over 48 to 96 hours with no rebound. Bleeding time was not affected. It also modestly lowered triglycerides and raised HDL cholesterol, and it raised heart rate by about 5 to 7 beats per minute.
How your body processes Cilostazol
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Cilostazol is absorbed after being taken by mouth, and a high-fat meal increases absorption. The liver breaks it down, mainly with CYP3A4 and to a lesser extent CYP2C19. Two breakdown products are active. Half-lives are about 11 to 13 hours, and levels reach steady state within a few days. Most is cleared through urine as metabolites, with the rest in feces.
How to store Cilostazol
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Store cilostazol tablets at 25°C (77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) .
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Cilostazol
286 supplements and herbal products have documented interactions with Cilostazol in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 5
- Moderate · 240
- Minor · 41
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Cilostazol: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Cilostazol — the kind of thing our pharmacy team would talk through with you at the counter.
What is cilostazol for?
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How should I take it?
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What side effects should I expect?
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Who shouldn't take cilostazol?
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Can I take it with my other medicines?
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Is it safe in pregnancy or while breastfeeding?
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Is Cilostazol available over the counter?
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When was Cilostazol first available?
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Who makes Cilostazol?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Cilostazol on HelloPharmacist
Cilostazol forms and strengths (how it comes)
Cilostazol is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Cilostazol tablets are used to reduce symptoms of intermittent claudication and improve walking distance.
- Cilostazol tablets are taken by mouth twice daily, at least 30 minutes before or 2 hours after breakfast and dinner.
- Your prescriber may lower the dose of Cilostazol tablets if you take certain CYP3A4 or CYP2C19 blocking medicines.
- If Cilostazol tablets haven't helped after 3 months, your prescriber may stop them.
Cilostazol on the U.S. market: products, makers and brands
How Cilostazol appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
9 companies list 16 Cilostazol product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 1999. Brand names on the directory include Pletal; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (6) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Cilostazol is used (Medicaid data)
A general measure of how commonly Cilostazol is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Cilostazol is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Cilostazol prescribed? Of the 1,601 medications we measure, Cilostazol ranks #518 by Medicaid prescriptions — more than 68% of them.
Utilization by Cilostazol product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
cilostazol 100 MG Oral Tablet Most dispensed
Summed across the 4 of 27 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 242461
cilostazol 50 MG Oral Tablet
Summed across the 4 of 21 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 242462
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Cilostazol, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 8 of 48 listed Cilostazol NDCs with Medicaid activity.
Compare Cilostazol products
A representative set of FDA-listed product records for Cilostazol — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 100 mg | Oral | Aphena Pharma Solutions - Tennessee, LLC × 2 listings | ANDA | View NDC → |
| 50 mg | Oral | Apotex Corp. | ANDA | View NDC → |
| 100 mg | Oral | Apotex Corp. | ANDA | View NDC → |
| 100 mg | Oral | AvKARE | ANDA | View NDC → |
| 50 mg | Oral | AvPAK | ANDA | View NDC → |
| 100 mg | Oral | AvPAK | ANDA | View NDC → |
| 50 mg | Oral | Bryant Ranch Prepack | ANDA | View NDC → |
| 100 mg | Oral | Bryant Ranch Prepack | ANDA | View NDC → |
| 50 mg | Oral | Chartwell RX, LLC | ANDA | View NDC → |
| 100 mg | Oral | Chartwell RX, LLC | ANDA | View NDC → |
| 50 mg | Oral | direct rx | ANDA | View NDC → |
| 50 mg | Oral | Slate Run Pharmaceuticals, LLC | ANDA | View NDC → |
| 100 mg | Oral | Slate Run Pharmaceuticals, LLC | ANDA | View NDC → |
| 50 mg | Oral | Teva Pharmaceuticals USA, Inc. | ANDA | View NDC → |
| 100 mg | Oral | Teva Pharmaceuticals USA, Inc. | ANDA | View NDC → |
Showing 16 of 16 products — FDA National Drug Code Directory. See every product, package size and price: browse all 16 Cilostazol NDCs →
Cilostazol side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Cilostazol — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Cilostazol in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Cilostazol FDA approval history
How Cilostazol went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Cilostazol recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Cilostazol recalls since July 2021.
✅No Cilostazol recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 21107 1 dose form · 2 strengths
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Dose form (SCDF) Oral Tablet RxCUI 371508In current FDA listings
Look up RxCUI 21107 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Cilostazol supply and shortage status
Whether Cilostazol is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Cilostazol costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Tablet · Oral | 100 mg | $0.132 per tablet | NDC details & price history |
| Tablet · Oral | 50 mg | $0.130 per tablet | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Cilostazol brand names
Cilostazol is sold under one brand name in the FDA directory — Pletal. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Cilostazol: manufacturers and labelers
9 companies list Cilostazol products with the FDA. By number of product records, the largest are Aphena Pharma Solutions - Tennessee, LLC, Apotex Corp., AvPAK. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Cilostazol drug class (RxNorm)
Cilostazol belongs to the Phosphodiesterase 3 Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Cilostazol page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Teva Pharmaceuticals USA, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →