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Rosuvastatin Side Effects

The most commonly reported side effects of rosuvastatin include fatigue, dyspnoea, and nausea, based on 221,151 FDA adverse event reports from 2004 to 2025. 4.6% of reports found the drug to be ineffective.

Rosuvastatin side effects

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

1
Fatigue5.6%12,311
2
Drug Ineffective4.6%10,272
3
Dyspnoea4.6%10,090
4
Nausea4.5%9,954
5
Off Label Use4.4%9,674
6
Diarrhoea4.3%9,564
7
Pain4.1%9,035
8
Headache3.7%8,101
9
Arthralgia3.4%7,451
10
Dizziness3.3%7,350
11
Asthenia3.1%6,833
12
Myalgia3.0%6,739
13
Malaise2.9%6,384
14
Fall2.9%6,354
15
Vomiting2.8%6,137

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

Report severity

68.4%Serious151,202 reports
31.5%Hospitalizations69,553 reports
5.9%Fatal13,083 reports

Seriousness is determined by the reporter, not by OpenClaim.

Rosuvastatin drug interactions

Other drugs that appear in adverse event reports alongside rosuvastatin. 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
Aspirin2.8%6,193
2
Metformin2.7%6,053
3
Esomeprazole2.7%5,946
4
Omeprazole2.5%5,631
5
Adalimumab2.5%5,508
6
Lenalidomide2.4%5,365
7
Atorvastatin-calcium2.4%5,329
8
Amlodipine2.2%4,894
9
Pantoprazole-sodium2.0%4,477
10
Prednisone1.9%4,155
11
Rituximab1.9%4,099
12
Niacin1.6%3,511
13
Dupilumab1.6%3,469
14
Apixaban1.5%3,337
15
Ezetimibe1.5%3,320

Taken alongside

1
Aspirin22.4%49,604
2
Metformin12.6%27,898
3
Levothyroxine-sodium12.4%27,456
4
Ergocalciferol12.3%27,139
5
Amlodipine11.7%25,843
6
Metoprolol11.3%24,937
7
Acetaminophen11.1%24,540
8
Furosemide9.4%20,813
9
Omeprazole8.8%19,515
10
Pantoprazole-sodium8.2%18,113
11
Lisinopril7.7%16,924
12
Insulin7.5%16,592
13
Hydrochlorothiazide7.0%15,494
14
Albuterol7.0%15,448
15
Gabapentin6.4%14,175

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 rosuvastatin side effects

49.0% of rosuvastatin adverse event reports involve female patients and 43.4% involve male patients. The largest age group is elderly at 58%. These figures reflect who reports side effects, not underlying risk.

Sex

Female49.0%
Male43.4%
Unknown7.6%

Age group

< 2<0.1%
2–11<0.1%
12–17<0.1%
18–6442.2%
65+57.6%

What is rosuvastatin used for

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

AbasiaAbdominal DiscomfortAccidental Exposure To ProductAcute Coronary SyndromeAcute Kidney InjuryAcute Myeloid LeukaemiaAcute Myocardial InfarctionAcute Respiratory Distress SyndromeAcute SinusitisAdenocarcinoma Of ColonAdministration Site PlaqueAdrenal AdenomaAdverse Drug ReactionAdverse EventAdverse Reaction

Showing 15 of 1,052 indications

Rosuvastatin brand names and reporting trend

Rosuvastatin is sold under brand names including Ezallor Sprinkle, Rosuvastatin Zinc.

Brand names

Ezallor Sprinkle115,688
Rosuvastatin Zinc11

Quarterly reports (20042025)

20052010201520202025

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

Taking rosuvastatin with another medication?

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