Prescription medicine
Fosinopril First approved as Monopril
Fosinopril (Monopril) is a prescription medicine with an FDA approval on record since 1991. FDA's NDC Directory lists it from 7 generic labelers, and pharmacies paid $0.154 per fosinopril sodium 10 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the fosinopril FDA label on DailyMed (effective October 10, 2025, Chartwell RX, LLC); the NDA 19915 record on Drugs@FDA; every fosinopril label on DailyMed.
Highlights of the record
FDA label of October 10, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
FETAL TOXICITY.
When pregnancy is detected, discontinue fosinopril sodium 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 usageFosinopril sodium tablets are indicated for the treatment of hypertension.
Forms and strengths
- 10 mg
- 20 mg
- 40 mg
Tablet.
On the market
- Earliest approval on file
- May 16, 1991 Monopril, Bristol Myers Squibb; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 11 first November 25, 2003; 5 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 7 of which 7 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.154 per tablet Fosinopril sodium 10 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 3 since 2013 0 Class I among all firms' recalls; latest July 2, 2013
- FAERS reports
- 4,243 through July 30, 2026
What is fosinopril used for?
From the label: indications and usageFosinopril sodium tablets are indicated for the treatment of hypertension. They may be used alone or in combination with thiazide diuretics. Fosinopril sodium tablets are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics with or without digitalis (see DOSAGE AND ADMINISTRATION ). In using fosinopril sodium tablets, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. […]
Conditions named in the indications of fosinopril's FDA labels, with every medicine labeled for each:
From other fosinopril labelsHigh blood pressure: INDICATIONS AND USAGE Fosinopril sodium tablets are indicated for the treatment of hypertension.
FDA pharmacologic class: Angiotensin Converting Enzyme Inhibitor.
Source: FDA drug label (Fosinopril Sodium), Chartwell RX, LLC, effective October 10, 2025 (SPL set ff1323cc-7ad8-488d-94a7-a11555db78a7), via openFDA; the full label on DailyMed
Is there a generic for fosinopril (Monopril)?
The FDA approved the first generic fosinopril on November 25, 2003. 11 generic applications are approved; 5 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 fosinopril from 7 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.
- 1991 earliest approval on file
- 2003 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 fosinopril (Monopril)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.154 per Fosinopril sodium 10 mg tablet, down 5% from $0.163 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.
- Fosinopril sodium 10 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Fosinopril sodium 10 mg tablet | Generic | $0.154 per tablet | $4.63 | -5% |
| Fosinopril sodium 20 mg tablet | Generic | $0.168 per tablet | $5.03 | +2% |
| Fosinopril sodium 40 mg tablet | Generic | $0.212 per tablet | $6.36 | -2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has fosinopril been recalled?
The FDA's Enforcement Report lists 3 recalls naming fosinopril since 2013: 0 Class I (the most serious), 3 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling:Label Mixup; FOSINOPRIL SODIUM Tablet, 10 mg may be potentially mislabeled as CALCITRIOL, Capsule, 0.25 mcg, NDC 00054000725, Pedigree: AD46414_10 … |
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling:Label Mixup; FOSINOPRIL SODIUM, Tablet, 20 mg may be potentially mislabeled as TOLTERODINE TARTRATE ER, Capsule, 2 mg, NDC 00009519001, Pedigree … |
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling: Label Mixup: FOSINOPRIL SODIUM, Tablet, 10 mg may have potentially been mislabeled as the following drug: MERCapsuleTOPURINE, Tablet, 50 mg, NDC … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the fosinopril label say about other medicines?
The fosinopril label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name fosinopril. 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 |
|---|---|---|
| Captopril | warnings | Neutropenia/Agranulocytosis Another angiotensin-converting enzyme inhibitor, captopril, has been shown to cause agranulocytosis and bone marrow depression, rarely in uncomplicated patients, but more frequently in patients with renal impairment, especially if they also have a collagen-vascular disease such as systemic … |
| Epinephrine | warnings | Where there is involvement of the tongue, glottis, or larynx, likely to cause airway obstruction, appropriate therapy, e.g., subcutaneous epinephrine solution 1:1000 (0.3 mL to 0.5 mL) should be promptly administered ( see PRECAUTIONS , Information for Patients and ADVERSE REACTIONS). |
Source: FDA drug label (Fosinopril Sodium), Chartwell RX, LLC, effective October 10, 2025 (SPL set ff1323cc-7ad8-488d-94a7-a11555db78a7), via openFDA; the full label on DailyMed
What do FAERS reports show for fosinopril?
The FDA Adverse Event Reporting System holds 4,243 reports that list fosinopril among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 400 are coded as a death and 1,947 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 fosinopril?
78 other medicines are given the same way (oral) and in the same FDA class as fosinopril 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 |
| Captopril | High blood pressure, Heart failure | 13 labelers | $0.228 per tablet 12.5 mg tablet | No current entry |
| Quinapril | High blood pressure, Heart failure | 9 labelers | n/a | In shortage |
Every medicine labeled for the same conditions as fosinopril
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does fosinopril compare with medicines for the same use?
1 side-by-side page set fosinopril beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to fosinopril
- 78 medicines for the same use
- Other ACE inhibitors
- the pharmacologic class, with prices and generics
- Fosinopril side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other