Prescription medicine
Captopril First approved as Capoten
Captopril (Capoten) is a prescription medicine with an FDA approval on record since 1981. FDA's NDC Directory lists it from 13 generic labelers, and pharmacies paid $0.228 per captopril 12.5 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the captopril FDA label on DailyMed (effective February 6, 2026, AiPing Pharmaceutical, Inc.); the NDA 18343 record on Drugs@FDA; every captopril label on DailyMed.
Highlights of the record
FDA label of February 6, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
FETAL TOXICITY.
When pregnancy is detected, discontinue captopril tablets as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See WARNINGS: Fetal Toxicity
Used for
From the label: indications and usageHypertension Captopril tablets are indicated for the treatment of hypertension.
Forms and strengths
- 12.5 mg
- 25 mg
- 50 mg
- 100 mg
Tablet.
On the market
- Earliest approval on file
- April 6, 1981 Capoten, Aarxion Anda Hlding; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 25 first March 31, 1995; 7 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 13 of which 13 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.228 per tablet Captopril 12.5 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 5 since 2015 0 Class I among all firms' recalls; latest May 22, 2015
- FAERS reports
- 9,557 through July 30, 2026
What is captopril used for?
From the label: indications and usageHypertension Captopril tablets are indicated for the treatment of hypertension. In using captopril tablets, consideration should be given to the risk of neutropenia/agranulocytosis (see WARNINGS ). Captopril tablets may be used as initial therapy for patients with normal renal function, in whom the risk is relatively low. In patients with impaired renal function, particularly those with collagen vascular disease, captopril should be reserved for hypertensives who have either developed unacceptable side effects on other drugs, or have failed to respond satisfactorily to drug combinations. […]
Conditions named in the indications of captopril's FDA labels, with every medicine labeled for each:
From other captopril labelsHigh blood pressure: INDICATIONS AND USAGE Hypertension Captopril tablets are indicated for the treatment of hypertension.
Heart failure: Heart Failure Captopril tablets are indicated in the treatment of congestive heart failure usually in combination with diuretics and digitalis.
Chronic kidney disease: Diabetic Nephropathy Captopril tablets are indicated for the treatment of diabetic nephropathy (proteinuria >500 mg/day) in patients with type I insulin-dependent diabetes mellitus and retinopathy.
FDA pharmacologic class: Angiotensin Converting Enzyme Inhibitor.
Source: FDA drug label (Captopril), AiPing Pharmaceutical, Inc., effective February 6, 2026 (SPL set 3b789f16-b291-4012-be39-af3beec3ff9a), via openFDA; the full label on DailyMed
Is there a generic for captopril (Capoten)?
The FDA approved the first generic captopril on March 31, 1995. 25 generic applications are approved; 7 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 captopril from 13 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.
- 1981 earliest approval on file
- 1995 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 captopril (Capoten)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.228 per Captopril 12.5 mg tablet, down 28% from $0.316 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.
- Captopril 25 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Captopril 100 mg tablet | Generic | $0.323 per tablet | $9.69 | +13% |
| Captopril 12.5 mg tablet | Generic | $0.228 per tablet | $6.85 | -28% |
| Captopril 25 mg tablet | Generic | $0.173 per tablet | $5.18 | +47% |
| Captopril 50 mg tablet | Generic | $0.369 per tablet | $11.07 | +17% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has captopril been recalled?
The FDA's Enforcement Report lists 5 recalls naming captopril since 2015: 0 Class I (the most serious), 5 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| May 22, 2015 | Class II | Blenheim Pharmacal, Inc. | cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wockhardt Limited, following a FDA inspection which noted … |
| April 22, 2015 | Class II | Wockhardt Usa Inc. | CGMP Deviations: Firm did not adequately investigate customer complaints. |
| March 12, 2015 | Class II | Wockhardt Usa Inc. | Failed Tablet/Capsule Specifications: out of specification for thickness. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the captopril label say about other medicines?
The captopril label names 14 other medicines in its interaction, contraindication or warning sections. The labels of 17 other medicines name captopril. 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 |
|---|---|---|
| Aliskiren | contraindications | Do not co-administer aliskiren with captopril tablets in patients with diabetes (see PRECAUTIONS, Drug Interactions ). |
| Allopurinol | drug interactions | In a study of healthy male volunteers no significant pharmacokinetic interaction occurred when captopril and allopurinol were administered concomitantly for 6 days. |
| Amiloride | drug interactions | Potassium-sparing diuretics such as spironolactone, triamterene, or amiloride, or potassium supplements should be given only for documented hypokalemia, and then with caution, since they may lead to a significant increase of serum potassium. |
| Epinephrine | warnings | Emergency therapy, including but not necessarily limited to, subcutaneous administration of a 1:1000 solution of epinephrine should be promptly instituted. |
| Everolimus | warnings | Information for Patients and ADVERSE REACTIONS .) Patients receiving coadministration of ACE inhibitor and mTOR (mammalian target of rapamycin) inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy or a neprilysin inhibitor may be at increased risk for angioedema (see PRECAUTIONS, Drug Interactions ). |
| Furosemide | drug interactions | Loop Diuretics: Furosemide administered concurrently with captopril does not alter the pharmacokinetics of captopril in renally impaired hypertensive patients. |
| Lithium | drug interactions | Increased serum lithium levels and symptoms of lithium toxicity have been reported in patients receiving concomitant lithium and ACE inhibitor therapy. |
| Nitroglycerin | drug interactions | Agents Having Vasodilator Activity: Data on the effect of concomitant use of other vasodilators in patients receiving captopril tablets for heart failure are not available; therefore, nitroglycerin or other nitrates (as used for management of angina) or other drugs having vasodilator activity should, if possible, be … |
| Procainamide | warnings | About half of the reported cases had serum creatinine ≥1.6 mg/dL and more than 75 percent were in patients also receiving procainamide. |
| Sacubitril and valsartan | contraindications | Do not administer captopril tablets within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor (see PRECAUTIONS, Drug Interactions ). |
| Sirolimus | warnings | Information for Patients and ADVERSE REACTIONS .) Patients receiving coadministration of ACE inhibitor and mTOR (mammalian target of rapamycin) inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy or a neprilysin inhibitor may be at increased risk for angioedema (see PRECAUTIONS, Drug Interactions ). |
| Spironolactone | drug interactions | Potassium-sparing diuretics such as spironolactone, triamterene, or amiloride, or potassium supplements should be given only for documented hypokalemia, and then with caution, since they may lead to a significant increase of serum potassium. |
| Temsirolimus | warnings | Information for Patients and ADVERSE REACTIONS .) Patients receiving coadministration of ACE inhibitor and mTOR (mammalian target of rapamycin) inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy or a neprilysin inhibitor may be at increased risk for angioedema (see PRECAUTIONS, Drug Interactions ). |
| Triamterene | drug interactions | Potassium-sparing diuretics such as spironolactone, triamterene, or amiloride, or potassium supplements should be given only for documented hypokalemia, and then with caution, since they may lead to a significant increase of serum potassium. |
Other labels that name captopril
Source: FDA drug label (Captopril), AiPing Pharmaceutical, Inc., effective February 6, 2026 (SPL set 3b789f16-b291-4012-be39-af3beec3ff9a), via openFDA; the full label on DailyMed
What do FAERS reports show for captopril?
The FDA Adverse Event Reporting System holds 9,557 reports that list captopril among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,564 are coded as a death and 4,816 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 else is labeled for the same conditions as captopril?
78 other medicines are given the same way (oral) and in the same FDA class as captopril or labeled mainly for the same use (high blood pressure), the same class first. High blood pressure lists all 88 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Lisinopril | High blood pressure, Heart failure | 36 labelers | $0.0254 per tablet 20 mg tablet | No current entry |
| Enalapril | High blood pressure, Heart failure | 29 labelers | $0.0664 per tablet 10 mg tablet | No current entry |
| Hydrochlorothiazide and lisinopril | High blood pressure | 27 labelers | $0.0293 per tablet 10-12.5 mg tablet | No current entry |
| Amlodipine and benazepril | High blood pressure | 16 labelers | $0.114 per unit 10-20 mg | No current entry |
| Benazepril | High blood pressure | 21 labelers | $0.0789 per tablet 20 mg tablet | No current entry |
| Ramipril | High blood pressure | 17 labelers | $0.0707 per capsule 10 mg capsule | No current entry |
| Quinapril | High blood pressure, Heart failure | 9 labelers | n/a | In shortage |
| Fosinopril | High blood pressure, Heart failure | 7 labelers | $0.154 per tablet 10 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does captopril compare with medicines for the same use?
12 side-by-side pages set captopril beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to captopril
- 78 medicines for the same use
- Other ACE inhibitors
- the pharmacologic class, with prices and generics
- Captopril side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other