This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
WARNING: FETAL TOXICITY WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning When pregnancy is detected, discontinue ramipril as soon as possible ( 5.6 ). Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus ( 5.6 ). When pregnancy is detected, discontinue ramipril as soon as possible ( 5.6 ). Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus ( 5.6 ).
Listed on the WHO Model List of Essential Medicines: a global expert panel judged it among the medicines a health system should always have, on evidence of value, not marketing.
Ramipril capsules are an angiotensin converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It may be used alone or in combination with thiazide diuretics ( 1.1 ). In patients 55 years or older at high risk of developing a major cardiovascular event, ramipril capsules are indicated to reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes ( 1.2 ). Ramipril capsules are indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardial infarction ( 1.3 ). 1.1 Hypertension Ramipril capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, includi...
Ramipril capsules are contraindicated in patients who are hypersensitive to this product or any other ACE inhibitor (e.g., a patient who has experienced angioedema during therapy with any other ACE inhibitor). Ramipril capsules are contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer ramipril capsules within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor [see Warnings and Precautions ( 5.1 )] . Do not co-administer ramipril capsules with aliskiren: in patients with diabetes Angioedema related to previous treatment with an ACE inhibitor, or a history of hereditary or idiopathic angioedema ( 4 ). Ramipril is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer ramipril within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor ( 4 ). Do not co-administer aliskiren with ramipril in patients with diabetes ( 4 ).
Angioedema, increased risk in patients with a prior history ( 5.1 ) Hypotension and hyperkalemia ( 5.5 , 5.8 ) Renal impairment: monitor renal function during therapy ( 5.3 ) Avoid concomitant use of an ACE inhibitor and angiotensin blocker ( 5.7 ) Rare cholestatic jaundice and hepatic failure ( 5.2 ) Rare neutropenia and agranulocytosis ( 5.4 ) 5.1 Anaphylactoid and Possibly Related Reactions Presumably because drugs that act directly on the renin-angiotensin-aldosterone system (e.g., ACE inhibitors) affect the metabolism of eicosanoids and polypeptides, including endogenous bradykinin, patients receiving these drugs (including ramipril) may be subject to a variety of adverse reactions, some of them serious. Angioedema Angioedema may occur at any time during treatment with ACE inhibitors including ramipril. Head and Neck Angioedema Patients with a history of angioedema unrelated to ACE inhibitor therapy may be at increased risk of angioedema while receiving an ACE inhibitor. Angioedema of the face, extremities, lips, tongue, glottis, and larynx has been reported in patients treated with ACE inhibitors. Angioedema associated with laryngeal edema can be fatal. If laryngeal stridor o...
The most common adverse reactions in patients with hypertension included headache, dizziness, fatigue, and cough ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Hypertension Ramipril has been evaluated for safety in over 4,000 patients with hypertension; of these, 1,230 patients were studied in U.S. controlled trials, and 1,107 were studied in foreign controlled trials. Almost 700 of these patients were treated for at least one year. The overall incidence of reported adverse events was similar in ramipril and placebo patients. The most frequent clinical side effects (possibly or probably related to study drug) reported by patients receiving ramipril in placebo-controlled trials were: headache (5.4%), dizziness (2.2%), and fatigue or asthenia (2%), but only the last one was more comm...
RECENT MAJOR CHANGES Warnings and Precautions, Angioedema ( 5.1 ) 2/2026
Source: FDA SPL label for Ramipril (Zydus Pharmaceuticals USA Inc.), effective 20260605. Full label on DailyMed.
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
| 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|---|
| 12,511 | 11,974 | 9,466 | 8,748 | 7,629 | 8,519 | 8,826 | 3,511 |
13,318 reports blaming this drug for every million Medicare prescriptions filled, which is 4.8× the typical drug on this site. (20,525 reports in 2024–2026, against 1,541,164 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
| Date | Class | Firm | Reason |
|---|---|---|---|
| 08/2026 | Class II | Hikma Pharmaceuticals USA INC. | Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU). |
| 10/2024 | Class II | Lupin Pharmaceuticals Inc. | CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor |
| 10/2024 | Class II | Lupin Pharmaceuticals Inc. | CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor |
| 10/2024 | Class II | Lupin Pharmaceuticals Inc. | CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor |
Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
In 2024, drug companies reported $0 in payments to US physicians and hospitals tied to this drug across 0 transactions.
No pending federal MDL names this drug or its brands.
Not named in any federal pharmaceutical settlement of $100M or more on record.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
| Product | Fills | $/fill |
|---|---|---|
| Ramipril | 1,539,276 | $11 |
| Altace | 1,888 | $656 |
1 drug in the same class grades a letter or more higher than ramipril on this site. Worth asking whether one of them would do the same job for you.
Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.