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Simvastatin Side Effects

The most commonly reported side effects of simvastatin include fatigue, diarrhoea, and nausea, based on 271,134 FDA adverse event reports from 2004 to 2025. 3.4% of reports found the drug to be ineffective.

Simvastatin side effects

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

1
Fatigue4.2%11,475
2
Diarrhoea3.7%9,977
3
Nausea3.6%9,744
4
Dyspnoea3.5%9,512
5
Drug Ineffective3.4%9,164
6
Dizziness3.0%8,257
7
Fall2.8%7,498
8
Acute Kidney Injury2.6%7,028
9
Headache2.6%7,010
10
Pain2.6%6,963
11
Off Label Use2.5%6,872
12
Asthenia2.5%6,748
13
Malaise2.4%6,372
14
Myalgia2.3%6,300
15
Arthralgia2.3%6,286

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

Report severity

72.9%Serious197,771 reports
38.5%Hospitalizations104,271 reports
8.7%Fatal23,655 reports

Seriousness is determined by the reporter, not by OpenClaim.

Simvastatin drug interactions

Other drugs that appear in adverse event reports alongside simvastatin. 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
Adalimumab3.5%9,619
2
Lenalidomide3.3%9,050
3
Omeprazole3.0%8,131
4
Aspirin2.7%7,408
5
Metformin2.6%7,059
6
Atorvastatin-calcium2.2%5,979
7
Ezetimibe2.1%5,789
8
Esomeprazole2.1%5,626
9
Pantoprazole-sodium1.8%4,916
10
Lansoprazole1.7%4,610
11
Rivaroxaban1.6%4,401
12
Niacin1.6%4,339
13
Amlodipine1.6%4,287
14
Hydrochlorothiazide1.5%4,098
15
Dabigatran-etexilate-mesylate1.4%3,920

Taken alongside

1
Aspirin25.0%67,815
2
Metformin14.6%39,506
3
Metoprolol13.4%36,255
4
Omeprazole13.2%35,873
5
Lisinopril13.1%35,441
6
Levothyroxine-sodium12.9%34,942
7
Furosemide12.4%33,507
8
Acetaminophen12.3%33,375
9
Amlodipine11.3%30,697
10
Ergocalciferol9.7%26,222
11
Hydrochlorothiazide9.0%24,528
12
Insulin8.0%21,772
13
Albuterol7.5%20,445
14
Gabapentin7.1%19,345
15
Losartan-potassium7.0%18,969

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 simvastatin side effects

48.5% of simvastatin adverse event reports involve female patients and 46.1% involve male patients. The largest age group is elderly at 62%. These figures reflect who reports side effects, not underlying risk.

Sex

Female48.5%
Male46.1%
Unknown5.4%

Age group

< 20.1%
2–11<0.1%
12–17<0.1%
18–6437.3%
65+62.5%

What is simvastatin used for

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

20,22-desmolase DeficiencyAbdominal DiscomfortAbdominal Pain UpperAccidental ExposureAccidental OverdoseAcquired Mixed HyperlipidaemiaAcute Coronary SyndromeAcute Myocardial InfarctionAcute Respiratory Distress SyndromeAcute Respiratory FailureAdenocarcinomaAdenocarcinoma Of ColonAdverse Drug ReactionAdverse EventAffective Disorder

Showing 15 of 1,004 indications

Simvastatin brand names and reporting trend

Simvastatin is sold under the brand name Zocor.

Brand names

Zocor221,203

Quarterly reports (20042025)

20052010201520202025

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

Taking simvastatin with another medication?

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