Prescription medicine
Cilostazol First approved as Pletal
Cilostazol (Pletal) is a prescription medicine with an FDA approval on record since 1999. FDA's NDC Directory lists it from 9 generic labelers, and pharmacies paid $0.132 per cilostazol 100 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the cilostazol FDA label on DailyMed (effective September 10, 2026, Apotex Corp.); the NDA 20863 record on Drugs@FDA; every cilostazol label on DailyMed.
Highlights of the record
FDA label of September 10, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
CONTRAINDICATED IN HEART FAILURE PATIENTS.
Cilostazol tablets are contraindicated in patients with heart failure of any severity. Cilostazol and several of its metabolites are inhibitors of phosphodiesterase III. Several drugs with this pharmacologic effect have caused decreased survival compared to placebo in patients with class III-IV heart failure [see Contraindications ( 4 )]. WARNING: CONTRAINDICATED IN HEART FAILURE PATIENTS See full prescribing information for complete boxed warning. Cilostazol tablets is contraindicated in patients with heart failure of any severity. Cilostazol and several of its metabolites are inhibitors of phosphodiesterase III. Several drugs with the pharmacologic effect have caused decreased survival compared to placebo patients with class III-IV heart failure.
Used for
From the label: indications and usageCilostazol tablets are indicated for the reduction of symptoms of intermittent claudication, as demonstrated by an increased walking distance.
Forms and strengths
- 50 mg
- 100 mg
Tablet.
On the market
- Earliest approval on file
- January 15, 1999 Pletal, Otsuka; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 15 first November 23, 2004; 8 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 9 of which 9 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.132 per tablet Cilostazol 100 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 0 since 2013 0 Class I among all firms' recalls; 4 more by firms not listed as its makers
- FAERS reports
- 6,131 through July 30, 2026
What is cilostazol used for?
From the label: indications and usageCilostazol tablets are indicated for the reduction of symptoms of intermittent claudication, as demonstrated by an increased walking distance. Cilostazol is a phosphodiesterase III inhibitor (PDE III inhibitor) indicated for the reduction of symptoms of intermittent claudication, as demonstrated by an increased walking distance
FDA pharmacologic class: Phosphodiesterase 3 Inhibitor.
Source: FDA drug label (cilostazol), Apotex Corp., effective September 10, 2026 (SPL set ceac1ae3-c343-28ca-c083-b748d21a15e6), via openFDA; the full label on DailyMed
What does the patient leaflet for cilostazol say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about cilostazol tablets?Cilostazol tablets can cause serious side effects: •Cilostazol stops a protein called phosphodiesterase III from working. Other similar drugs which affect this protein may cause death if you already have heart problems, called class 3 to 4 (III-IV) heart failure. Do not take cilostazol tablets if you have heart failure of any kind.
From the patient leaflet: How should I store cilostazol tablets?Store cilostazol tablets at 68°F to 77°F (20°C to 25°C). Keep cilostazol tablets and all medicines out of the reach of children.
Source: FDA drug label (Cilostazol), Slate Run Pharmaceuticals, LLC, effective December 12, 2025 (SPL set db0278e9-4ece-4aaf-9216-6bcbec58206a), via openFDA; the full label on DailyMed
Is there a generic for cilostazol (Pletal)?
The FDA approved the first generic cilostazol on November 23, 2004. 15 generic applications are approved; 8 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists cilostazol from 9 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1999 earliest approval on file
- 2004 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for cilostazol (Pletal)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.132 per Cilostazol 100 mg tablet, up 3% from $0.128 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Cilostazol 100 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Cilostazol 100 mg tablet | Generic | $0.132 per tablet | $3.95 | +3% |
| Cilostazol 50 mg tablet | Generic | $0.130 per tablet | $3.91 | +14% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has cilostazol been recalled?
The FDA's Enforcement Report lists 4 recalls naming cilostazol since 2013: 0 Class I (the most serious), 4 Class II, 0 Class III; 0 still ongoing. 4 of them are by firms that FDA's NDC Directory does not list as a maker of cilostazol and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling:Label Mixup; CILOSTAZOL Tablet, 100 mg may be potentially mislabeled as DUTASTERIDE, Capsule, 0.5 mg, NDC 00173071204, Pedigree: AD65475_1, EXP … |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: CILOSTAZOL, Tablet, 100 mg may be potentially mislabeled as the following drug: CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826 … |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: CILOSTAZOL, Tablet, 100 mg may have potentially been mislabeled as the following drug: TRIAMTERENE/ HYDROCHLOROTHIAZIDE, Tablet, 37.5 … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the cilostazol label say about other medicines?
The cilostazol label names 4 other medicines in its interaction, contraindication or warning sections. The labels of 15 other medicines name cilostazol. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Diltiazem | drug interactions | 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. |
| Erythromycin | drug interactions | 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. |
| Ketoconazole | drug interactions | 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. |
| Omeprazole | drug interactions | Inhibitors of CYP2C19 Coadministration with CYP2C19 inhibitors (e.g., omeprazole) increases systemic exposure of cilostazol active metabolites. |
Other labels that name cilostazol
Source: FDA drug label (cilostazol), Apotex Corp., effective September 10, 2026 (SPL set ceac1ae3-c343-28ca-c083-b748d21a15e6), via openFDA; the full label on DailyMed
What do FAERS reports show for cilostazol?
The FDA Adverse Event Reporting System holds 6,131 reports that list cilostazol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 979 are coded as a death and 2,859 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other phosphodiesterase 3 inhibitors
- the pharmacologic class, with prices and generics
- Cilostazol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other