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Irbesartan Side Effects

The most commonly reported side effects of irbesartan include acute kidney injury, fatigue, and nausea, based on 51,436 FDA adverse event reports from 2004 to 2025. 3.8% of reports found the drug to be ineffective.

Irbesartan side effects

Percentages show how often each reaction appears relative to total reports for irbesartan.

1
Acute Kidney Injury4.6%2,381
2
Fatigue4.5%2,317
3
Nausea4.1%2,092
4
Diarrhoea4.0%2,046
5
Drug Ineffective3.8%1,961
6
Fall3.6%1,845
7
Off Label Use3.6%1,828
8
Dyspnoea3.3%1,705
9
Headache3.3%1,698
10
Dizziness3.3%1,674
11
Malaise3.0%1,527
12
Asthenia2.9%1,506
13
Pain2.7%1,391
14
Blood Pressure Increased2.7%1,390
15
Cough2.6%1,333

These are voluntary reports and do not establish that irbesartan caused these reactions.

Report severity

76.7%Serious39,443 reports
41.9%Hospitalizations21,535 reports
7.2%Fatal3,699 reports

Seriousness is determined by the reporter, not by OpenClaim.

Irbesartan drug interactions

Other drugs that appear in adverse event reports alongside irbesartan. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Hydrochlorothiazide8.2%4,232
2
Metformin4.7%2,395
3
Amlodipine3.9%2,005
4
Atorvastatin-calcium3.1%1,588
5
Furosemide3.0%1,537
6
Omeprazole2.9%1,487
7
Adalimumab2.5%1,292
8
Rituximab2.4%1,212
9
Pantoprazole-sodium2.2%1,141
10
Lenalidomide2.2%1,110
11
Aspirin2.1%1,066
12
Bisoprolol-fumarate2.0%1,026
13
Methotrexate1.9%957
14
Esomeprazole1.7%883
15
Rosuvastatin1.7%880

Taken alongside

1
Hydrochlorothiazide17.9%9,191
2
Aspirin16.7%8,580
3
Amlodipine15.0%7,715
4
Atorvastatin-calcium13.9%7,171
5
Metformin12.9%6,658
6
Levothyroxine-sodium12.0%6,171
7
Acetaminophen11.6%5,941
8
Furosemide10.9%5,584
9
Omeprazole9.1%4,704
10
Metoprolol8.9%4,592
11
Insulin8.1%4,154
12
Ergocalciferol8.1%4,144
13
Pantoprazole-sodium7.1%3,677
14
Simvastatin7.0%3,596
15
Rosuvastatin6.8%3,502

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports irbesartan side effects

53.1% of irbesartan adverse event reports involve female patients and 39.0% involve male patients. The largest age group is elderly at 64%. These figures reflect who reports side effects, not underlying risk.

Sex

Female53.1%
Male39.0%
Unknown7.9%

Age group

< 20.2%
2–110.1%
12–170.1%
18–6435.6%
65+64.0%

What is irbesartan used for

Conditions and purposes for which patients were taking irbesartan when the adverse event was reported.

Accidental ExposureAccidental Exposure To ProductAcute Coronary SyndromeAcute Myocardial InfarctionAdrenal DisorderAlbuminuriaAlport^s SyndromeAmnesiaAnamnestic ReactionAngina PectorisAngiopathyAntacid TherapyAnticoagulant TherapyAnxietyAortic Aneurysm

Showing 15 of 420 indications

Irbesartan brand names and reporting trend

Irbesartan is sold under the brand name Avalide.

Brand names

Avalide34,987

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking irbesartan with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.