What the label lists and what reports show
Azilsartan side effects
Azilsartan's FDA label: “The most common adverse reaction in adults was diarrhea (2%).” FAERS holds 2,982 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 diarrhoea (166 reports).
- Generic listed
- Boxed warning
Check it at the source: the azilsartan FDA label on DailyMed (effective January 23, 2024, Azurity 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 Edarbi?Edarbi may cause side effects, including: Harm or death to your unborn fetus if taken in the second or third trimester. See " What is the most important information I should know about Edarbi? " Low blood pressure (hypotension) and dizziness is most likely to happen if you also: take water pills (diuretics) are on a low-salt diet take other medicines that affect your blood pressure get sick with vomiting or diarrhea do not drink enough fluids If you feel faint or dizzy, lie down and call your doctor right away. These are not all the possible side effects with Edarbi. Tell your doctor if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How do I store Edarbi? Store Edarbi at 59°F to 86°F (15°C to 30°C). […]
Source: FDA drug label, Azurity Pharmaceuticals, Inc., effective January 23, 2024 (SPL set 52b27c75-9f5a-4816-bafd-dace9d7d2063), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reaction in adults was diarrhea (2%).
From the label: adverse reactions, continuedThe most common adverse reaction in adults was diarrhea (2%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449 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. A total of 4814 patients were evaluated for safety when treated with Edarbi at doses of 20, 40, or 80 mg in clinical trials. This includes 1704 patients treated for at least six months; of these, 588 were treated for at least one year. Treatment with Edarbi was well-tolerated with an overall incidence of adverse reactions similar to placebo. The rate of withdrawals due to adverse events in placebo-controlled monotherapy and combination therapy trials was 2.4% (19/801) for placebo, 2.2% (24/1072) for Edarbi 40 mg, and 2.7% (29/1074) for Edarbi 80 mg. The most common adverse event leading to discontinuation, hypotension/orthostatic hypotension, was reported by 0.4% (8/2146) patients randomized to Edarbi 40 mg or 80 mg compared to 0% (0/801) patients randomized to placebo. Generally, adverse reactions were mild, not dose related, and similar regardless of age, gender, and race. …
Source: FDA drug label, Azurity Pharmaceuticals, Inc., effective January 23, 2024 (SPL set 52b27c75-9f5a-4816-bafd-dace9d7d2063), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,982 reports list azilsartan among the medicines taken, each a report of something that happened, not proof the medicine caused it; 250 are coded as a death and 1,110 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, 8 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?
- Azilsartan: 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