What the label lists and what reports show
Lovastatin side effects
Lovastatin's FDA label lists its adverse reactions in its own words. FAERS holds 25,526 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 (1,537 reports).
- Generic listed
Check it at the source: the lovastatin FDA label on DailyMed (effective May 6, 2026, Lupin Pharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsPhase III Clinical Studies In Phase III controlled clinical studies involving 613 patients treated with lovastatin, the adverse experience profile was similar to that shown below for the 8,245-patient EXCEL study (see Expanded Clinical Evaluation of Lovastatin [EXCEL] Study ). Persistent increases of serum transaminases have been noted (see WARNINGS, Liver Dysfunction ). About 11% of patients had elevations of CK levels of at least twice the normal value on one or more occasions. The corresponding values for the control agent cholestyramine was 9 percent. This was attributable to the noncardiac fraction of CK. Large increases in CK have sometimes been reported (see WARNINGS, Myopathy/Rhabdomyolysis ). …
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Reaction | Placebo ( N = 1663 ) % | Lovastatin 20 mg q . p . m . ( N = 1642 ) % | Lovastatin 40 mg q . p . m . ( N = 1645 ) % | Lovastatin 20 mg b . i . d . ( N = 1646 ) % | Lovastatin 40 mg b . i . d . ( N = 1649 ) % |
|---|---|---|---|---|---|
| Asthenia | 1.4 | 1.7 | 1.4 | 1.5 | 1.2 |
| Abdominal pain | 1.6 | 2.0 | 2.0 | 2.2 | 2.5 |
| Constipation | 1.9 | 2.0 | 3.2 | 3.2 | 3.5 |
| Diarrhea | 2.3 | 2.6 | 2.4 | 2.2 | 2.6 |
| Dyspepsia | 1.9 | 1.3 | 1.3 | 1.0 | 1.6 |
| Flatulence | 4.2 | 3.7 | 4.3 | 3.9 | 4.5 |
| Nausea | 2.5 | 1.9 | 2.5 | 2.2 | 2.2 |
| Muscle cramps | 0.5 | 0.6 | 0.8 | 1.1 | 1.0 |
| Myalgia | 1.7 | 2.6 | 1.8 | 2.2 | 3.0 |
| Dizziness | 0.7 | 0.7 | 1.2 | 0.5 | 0.5 |
| Headache | 2.7 | 2.6 | 2.8 | 2.1 | 3.2 |
| Rash | 0.7 | 0.8 | 1.0 | 1.2 | 1.3 |
| Blurred vision | 0.8 | 1.1 | 0.9 | 0.9 | 1.2 |
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, Lupin Pharmaceuticals, Inc., effective May 6, 2026 (SPL set df7ddf4f-d569-431e-81f1-9129d7043150), via openFDA; the full label on DailyMed
What do FAERS reports show?
25,526 reports list lovastatin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2,065 are coded as a death and 6,957 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 22 reactions below, 14 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?
- Lovastatin: 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