Prescription medication · ACE Inhibitor
fosinopril
Also sold as Monopril. Fosinopril is used to treat high blood pressure.
Data updated 2026-05-15
- 4,213
- FDA reportsLightly reported
- 12
- InteractionsSeveral interactions
- $0.15
- Generic price (NADAC)
What the data shows
fosinopril (Monopril) is a prescription ACE Inhibitor, among the least-reported drugs the FDA tracks (4,213 FDA reports), with 12 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.
fosinopril (Monopril) is a prescription ACE Inhibitor. Fosinopril is used to treat high blood pressure.
Fosinopril is a medicine that lowers blood pressure. It can also help manage heart failure.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Generic Price
$0.15/unit
Generic Available
Yes (6 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Fosinopril is used to treat high blood pressure.
Common side effects
Cough, Dizziness, Nausea
Key warnings
Fosinopril can harm your unborn baby, even causing death.
The sections below are summarized in plain English from fosinopril's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Fosinopril belongs to a class of drugs called ACE inhibitors. It works by blocking a substance in your body that tightens blood vessels. This helps your blood vessels relax and lowers your blood pressure.
Side Effects (from patient reports)
Based on 4,213 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for fosinopril, by number of reports
- Fatigue
Fatigue
239 reports
- Diarrhoea
Diarrhoea
232 reports
- Dyspnoea
Dyspnoea
210 reports
- Nausea
Nausea
204 reports
- Dizziness
Dizziness
179 reports
- Acute Kidney Injury
Acute Kidney Injury
176 reports
- Asthenia
Asthenia
170 reports
- Renal Failure
Renal Failure
160 reports
- Hypotension
Hypotension
142 reports
- Pain
Pain
142 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 fosinopril 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 fosinopril sits
fosinopril has more FDA adverse-event reports than 23% 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 fosinopril; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 4,213 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
4,213
Reports Mentioning Death
398
9.4% of reports — not proof of cause
Hospitalization Reports
1,936
Top Indication
Hypertension
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | FATIGUE | 239 |
| 2 | DIARRHOEA | 232 |
| 3 | DYSPNOEA | 210 |
| 4 | NAUSEA | 204 |
| 6 | DIZZINESS | 179 |
| 7 | ACUTE KIDNEY INJURY | 176 |
| 8 | ASTHENIA | 170 |
| 9 | RENAL FAILURE | 160 |
| 10 | HYPOTENSION | 142 |
| 11 | PAIN | 142 |
| 12 | HEADACHE | 141 |
| 13 | MYOCARDIAL INFARCTION | 131 |
| 14 | VOMITING | 131 |
| 15 | DRUG INTERACTION | 129 |
| 16 | FALL | 128 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Fosinopril can harm your unborn baby, even causing death. Stop taking fosinopril as soon as you know you are pregnant.
Known Drug Interactions
Dual Blockade of the Renin-Angiotensin System (RAS) Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Do not co-administer aliskiren with fosinopril in patients with diabetes. Avoid concomitant use of aliskiren with fosinopril in patients with renal impairment (GFR<60 mL/min/1.73 m 2 ).
Mechanism: Both drugs affect the same system that controls blood pressure and kidney function. Using them together increases the risk of very low blood pressure, high potassium levels, and kidney failure.
Lithium Increased serum lithium levels and symptoms of lithium toxicity have been reported in patients receiving ACE inhibitors during therapy with lithium. These drugs should be coadministered with caution, and frequent monitoring of serum lithium levels is recommended. If a diuretic is also used, the risk of lithium toxicity may be increased.
Mechanism: Fosinopril can make it harder for your body to get rid of lithium, causing it to build up to toxic levels in your blood.
In separate single or multiple dose pharmacokinetic interaction studies with chlorthalidone, nifedipine, propranolol, hydrochlorothiazide, cimetidine, metoclopramide, propantheline, digoxin, and warfarin, the bioavailability of fosinoprilat was not altered by coadministration of fosinopril with any one of these drugs.
Mechanism: Studies show that taking these two medications together does not change how much of the medicine is absorbed into your bloodstream.
In a study with concomitant administration of aspirin and fosinopril sodium, the bioavailability of unbound fosinoprilat was not altered.
Mechanism: Taking aspirin at the same time as fosinopril does not change the amount of active medicine available for your body to use.
In separate single or multiple dose pharmacokinetic interaction studies with chlorthalidone, nifedipine, propranolol, hydrochlorothiazide, cimetidine, metoclopramide, propantheline, digoxin, and warfarin, the bioavailability of fosinoprilat was not altered by coadministration of fosinopril with any one of these drugs.
Mechanism: These two drugs do not interfere with each other's levels in the body when they are taken together.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
Can I take fosinopril with food?
What should I do if I feel dizzy after taking fosinopril?
Can I take potassium supplements while taking fosinopril?
How long will I need to take fosinopril?
Can fosinopril cause a cough?
Can I drink alcohol while taking fosinopril?
What if I have diabetes?
Will this medicine affect my ability to drive?
Can I stop taking this medicine if my blood pressure is normal?
What strengths does this medication come in?
What are the common side effects of fosinopril?
Does fosinopril interact with other medications?
What drug class is fosinopril?
What pregnancy or breastfeeding source fields are listed for fosinopril?
Related Medications in ACE Inhibitor
Other drugs grouped near fosinopril - same-class peers and common alternatives.
acebutolol
Sectral
Acebutolol is a medicine that helps lower blood pressure and control irregular heartbeats.
Compare with fosinopril →
aliskiren
Tekturna
Tekturna is a medicine used to treat high blood pressure.
Compare with fosinopril →
amiloride
Midamor
Amiloride is a water pill that helps your body hold onto potassium.
Compare with fosinopril →
amlodipine
Norvasc
Amlodipine (Norvasc) is a drug that lowers blood pressure and treats chest pain.
Compare with fosinopril →
amlodipine/benazepril
Lotrel
Lotrel is a combination medicine that contains amlodipine and benazepril.
Compare with fosinopril →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for fosinopril: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 4,213.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 9.45%.
- sitagliptin Δ 0.02 pts · 70,292 reports · DPP-4 Inhibitor 9.47%death share
- dutasteride Δ 0.02 pts · 20,677 reports · 5-Alpha Reductase Inhibitor 9.43%death share
- telmisartan Δ 0.03 pts · 33,611 reports · Angiotensin II Receptor Blocker (ARB) 9.42%death share
- gabapentin Δ 0.06 pts · 351,750 reports · Anticonvulsant / Nerve Pain Agent 9.38%death share
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
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for fosinopril
The FDA label for fosinopril (sold under brand names such as Monopril) classifies it as a prescription-only medication in the ACE Inhibitor class. Fosinopril is used to treat high blood pressure. Official labeling lists 4 commonly reported side effects, including Cough, Dizziness, Nausea.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 4,213 voluntary reports. The database also lists 12 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $0.15.
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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: October 25, 2021
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
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 from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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