What the label lists and what reports show
Amlodipine and olmesartan side effects
Amlodipine and olmesartan's FDA label: “Most common adverse reaction (incidence ≥3%) is edema ( 6.1 ).” FAERS holds 2,672 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 sprue-like enteropathy (338 reports).
- Generic listed
- Boxed warning
Check it at the source: the amlodipine and olmesartan FDA label on DailyMed (effective July 12, 2023, Cosette Pharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reaction (incidence ≥3%) is edema ( 6.1 ).
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Reaction | Male=% (N=914) | Female=% (N=336) | Male=% (N=1218) | Female=% (N=512) |
|---|---|---|---|---|
| Edema | 1.4 | 5.1 | 5.6 | 14.6 |
| Flushing | 0.3 | 0.9 | 1.5 | 4.5 |
| Palpitation | 0.9 | 0.9 | 1.4 | 3.3 |
| Somnolence | 0.8 | 0.3 | 1.3 | 1.6 |
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, continuedMost common adverse reaction (incidence ≥3%) is edema ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Azor The data described below reflect exposure to Azor in more than 1600 patients including more than 1000 exposed for at least 6 months and more than 700 exposed for 1 year. Azor was studied in one placebo-controlled factorial trial [s ee Clinical Trials ( 14.1 ) ]. The population had a mean age of 54 years and included approximately 55% males. Seventy-one percent were Caucasian and 25% were Black. Patients received doses ranging from 5/20 mg to 10/40 mg orally once daily. The overall incidence of adverse reactions on therapy with Azor was similar to that seen with corresponding doses of the individual components of Azor, and to placebo. The reported adverse reactions were generally mild and seldom led to discontinuation of treatment (2.6% for Azor and 6.8% for placebo). Edema Edema is a known, dose-dependent adverse effect of amlodipine but not of olmesartan medoxomil. …
Source: FDA drug label, Cosette Pharmaceuticals, Inc., effective July 12, 2023 (SPL set c5535406-b63b-49aa-88b9-169aaf0ed08e), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,672 reports list amlodipine and olmesartan among the medicines taken, each a report of something that happened, not proof the medicine caused it; 101 are coded as a death and 956 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 24 reactions below, 10 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 olmesartan: 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