What the label lists and what reports show
Rosuvastatin side effects
Rosuvastatin's FDA label lists its adverse reactions in its own words. FAERS holds 110,043 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 fatigue (8,482 reports).
- Generic listed
Check it at the source: the rosuvastatin FDA label on DailyMed (effective September 4, 2026, ScieGen 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 rosuvastatin tablets?Rosuvastatin tablets may cause serious side effects, including: Muscle pain, tenderness and weakness (myopathy). Muscle problems, including muscle breakdown, can be serious in some people and rarely cause kidney damage that can lead to death. Tell your healthcare provider right away if: you have unexplained muscle pain, tenderness, or weakness, especially if you have a fever or feel more tired than usual, while you take rosuvastatin tablets. you have muscle problems that do not go away even after your healthcare provider has told you to stop taking rosuvastatin tablets. Your healthcare provider may do further tests to diagnose the cause of your muscle problems. […]
Source: FDA drug label, ScieGen Pharmaceuticals, Inc., effective September 4, 2026 (SPL set ee4933c5-0d97-494d-ac0f-2083e0100836), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe following important adverse reactions are described below and elsewhere in the labeling: Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.1) ] Immune-Mediated Necrotizing Myopathy [see Warnings and Precautions (5.2) ] Hepatic Dysfunction [see Warnings and Precautions (5.3) ] Proteinuria and Hematuria [see Warnings and Precautions (5.4) ] Increases in HbA1c and Fasting Serum Glucose Levels [see Warnings and Precautions (5.5) ] Most frequent adverse reactions (rate ≥ 2%) are headache, nausea, myalgia, asthenia, and constipation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact ScieGen Pharmaceuticals, Inc., at 1-855-724-3436 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Table 3: Adverse Reactions Reported in ≥ 2% of Patients Treated with Rosuvastatin and > Placebo in the METEOR Trial
| Adverse Reactions | Placebo N=281% | Rosuvastatin 40 mg N=700% |
|---|---|---|
| Myalgia | 12.1 | 12.7 |
| Arthralgia | 7.1 | 10.1 |
| Headache | 5.3 | 6.4 |
| Dizziness | 2.8 | 4.0 |
| Increased CPK | 0.7 | 2.6 |
| Abdominal pain | 1.8 | 2.4 |
| ALT greater than 3x ULN 1 | 0.7 | 2.2 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, ScieGen Pharmaceuticals, Inc., effective September 4, 2026 (SPL set ee4933c5-0d97-494d-ac0f-2083e0100836), via openFDA; the full label on DailyMed
What do FAERS reports show?
110,043 reports list rosuvastatin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 6,970 are coded as a death and 38,707 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 23 reactions below, 11 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?
- Rosuvastatin: 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