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Isosorbide Side Effects

The most commonly reported side effects of isosorbide include chronic kidney disease, dyspnoea, and acute kidney injury, based on 59,965 FDA adverse event reports from 2004 to 2025. 2.7% of reports found the drug to be ineffective.

Isosorbide side effects

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

1
Chronic Kidney Disease5.4%3,232
2
Dyspnoea4.9%2,927
3
Acute Kidney Injury4.7%2,793
4
Diarrhoea4.7%2,793
5
Fatigue4.5%2,679
6
Nausea4.3%2,571
7
Dizziness3.9%2,328
8
Renal Failure3.6%2,141
9
Myocardial Infarction3.3%1,959
10
Headache3.1%1,840
11
Chest Pain3.1%1,837
12
Off Label Use3.0%1,814
13
Death3.0%1,802
14
Vomiting2.9%1,761
15
Pain2.8%1,665

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

Report severity

79.1%Serious47,416 reports
45.1%Hospitalizations27,044 reports
12.6%Fatal7,561 reports

Seriousness is determined by the reporter, not by OpenClaim.

Isosorbide drug interactions

Other drugs that appear in adverse event reports alongside isosorbide. 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
Omeprazole6.6%3,951
2
Esomeprazole5.6%3,383
3
Lansoprazole5.0%2,997
4
Pantoprazole-sodium4.2%2,516
5
Aspirin3.7%2,239
6
Lenalidomide3.7%2,204
7
Rosiglitazone-maleate2.6%1,573
8
Apixaban2.5%1,482
9
Furosemide2.4%1,464
10
Atorvastatin-calcium2.4%1,419
11
Simvastatin2.0%1,208
12
Amlodipine2.0%1,198
13
Metoprolol1.9%1,166
14
Adalimumab1.9%1,166
15
Rivaroxaban1.9%1,165

Taken alongside

1
Aspirin39.9%23,910
2
Furosemide28.3%16,988
3
Metoprolol24.4%14,613
4
Atorvastatin-calcium24.2%14,493
5
Acetaminophen18.4%11,062
6
Amlodipine18.4%11,005
7
Nitroglycerin17.3%10,396
8
Lisinopril14.3%8,566
9
Omeprazole14.1%8,460
10
Levothyroxine-sodium13.9%8,348
11
Simvastatin13.8%8,262
12
Carvedilol13.6%8,138
13
Insulin13.5%8,084
14
Clopidogrel-bisulfate12.7%7,624
15
Albuterol12.7%7,619

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 isosorbide side effects

45.5% of isosorbide adverse event reports involve female patients and 48.0% involve male patients. The largest age group is elderly at 66%. These figures reflect who reports side effects, not underlying risk.

Sex

Female45.5%
Male48.0%
Unknown6.4%

Age group

< 20.2%
2–110.3%
12–170.1%
18–6432.9%
65+66.5%

What is isosorbide used for

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

5q Minus SyndromeAbdominal DiscomfortAbdominal DistensionAbdominal PainAbdominal Pain LowerAbdominal Pain UpperAbdominal RigidityAbstains From AlcoholAccidental ExposureAcute Coronary SyndromeAcute Kidney InjuryAcute Myocardial InfarctionAcute Pulmonary OedemaAdverse EventAdverse Reaction

Showing 15 of 707 indications

Isosorbide brand names and reporting trend

Isosorbide is sold under brand names including Monoket, Ismotic, Bidil.

Brand names

Monoket23,547
Ismotic13,336
Bidil9,294

Quarterly reports (20042025)

20052010201520202025

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

Taking isosorbide with another medication?

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