What the label lists and what reports show
Amlodipine and benazepril side effects
Amlodipine and benazepril's FDA label: “The most common reasons for discontinuation of therapy with amlodipine and benazepril hydrochloride were cough and edema.” FAERS holds 643 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 fatigue (47 reports).
- Generic listed
- Boxed warning
Check it at the source: the amlodipine and benazepril FDA label on DailyMed (effective October 3, 2025, Lupin Pharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of amlodipine and benazepril hydrochloride capsules?Amlodipine and benazepril hydrochloride capsules can cause serious side effects including: serious allergic reactions that can be life threatening. Stop amlodipine and benazepril hydrochloride capsules and get emergency help right away if you get: - swelling of your face, eyelids, lips, tongue or throat - have trouble swallowing - asthma (wheezing) or other breathing problems These allergic reactions are rare but happen more times in people who are African-American. low blood pressure (hypotension).Low blood pressure is most likely to happen if you also take water pills, are on a low salt diet, get dialysis treatments, have heart problems or get sick with vomiting or diarrhea. Lie down if you feel faint or dizzy. liver problems. […]
Source: FDA drug label, Lupin Pharmaceuticals, Inc., effective October 3, 2025 (SPL set 968c611b-43a7-40f0-9ed3-aa67ee88364b), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common reasons for discontinuation of therapy with amlodipine and benazepril hydrochloride were cough and edema.
Percent Incidence in U. S. Placebo-controlled Trials
| Reaction | Benazepril/Amlodipine N = 760 | Benazepril N = 554 | Amlodipine N = 475 | Placebo N = 408 |
|---|---|---|---|---|
| Cough | 3.3 | 1.8 | 0.4 | 0.2 |
| Headache | 2.2 | 3.8 | 2.9 | 5.6 |
| Dizziness | 1.3 | 1.6 | 2.3 | 1.5 |
| Edema Edema refers to all edema, such as dependent edema, angioedema, facial edema. | 2.1 | 0.9 | 5.1 | 2.2 |
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, continuedDiscontinuation because of adverse reactions occurred in 4% of amlodipine and benazepril hydrochloride-treated patients and 3% of placebo-treated patients. The most common reasons for discontinuation of therapy with amlodipine and benazepril hydrochloride were cough and edema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 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, 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. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. Amlodipine and benazepril hydrochloride has been evaluated for safety in over 2,991 patients with hypertension; over 500 of these patients were treated for at least 6 months, and over 400 were treated for more than 1 year. …
Source: FDA drug label, Lupin Pharmaceuticals, Inc., effective October 3, 2025 (SPL set 968c611b-43a7-40f0-9ed3-aa67ee88364b), via openFDA; the full label on DailyMed
What do FAERS reports show?
643 reports list amlodipine and benazepril among the medicines taken, each a report of something that happened, not proof the medicine caused it; 66 are coded as a death and 166 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 21 reactions below, 13 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?
- Amlodipine and benazepril: 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