What the label lists and what reports show
Ramipril side effects
Ramipril's FDA label: “The most common adverse reactions in patients with hypertension included headache, dizziness, fatigue, and cough ( 6.1 ).” FAERS holds 123,138 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is dyspnoea (8,357 reports).
- Generic listed
- Boxed warning
Check it at the source: the ramipril FDA label on DailyMed (effective August 24, 2026, Lupin Pharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions in patients with hypertension included headache, dizziness, fatigue, and cough ( 6.1 ).
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Adverse Event | Placebo (N=982) | Ramipril (N=1004) |
|---|---|---|
| Hypotension | 5% | 11% |
| Cough increased | 4% | 8% |
| Dizziness | 3% | 4% |
| Angina pectoris | 2% | 3% |
| Nausea | 1% | 2% |
| Postural hypotension | 1% | 2% |
| Syncope | 1% | 2% |
| Vomiting | 0.5% | 2% |
| Vertigo | 0.7% | 2% |
| Abnormal kidney function | 0.5% | 1% |
| Diarrhea | 0.4% | 1% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe most common adverse reactions in patients with hypertension included headache, dizziness, fatigue, and cough ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or the 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 4000 patients with hypertension; of these, 1230 patients were studied in U.S. controlled trials, and 1107 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 (2.0%), but only the last one was more common in ramipril patients than in patients given placebo. Generally the side effects were mild and transient, and there was no relation to total dosage within the range of 1.25 mg to 20 mg. …
Source: FDA drug label, Lupin Pharmaceuticals, Inc., effective August 24, 2026 (SPL set a8cdec12-81d1-4ef4-82c0-d05d93c37a07), via openFDA; the full label on DailyMed
What do FAERS reports show?
123,138 reports list ramipril among the medicines taken, each a report of something that happened, not proof the medicine caused it; 13,282 are coded as a death and 64,691 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. Of the 20 reactions below, 12 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Ramipril: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions