Drug Landscape ›
Simvastatin 40mg ›
Regulatory · United States
Marketing authorisation
FDA
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
Window: 20 April 2025 – 20 April 2026
Total reports: 145
Most-reported reactions
Myalgia — 25 reports (17.24%) Rhabdomyolysis — 23 reports (15.86%) Drug Interaction — 16 reports (11.03%) Blood Creatine Phosphokinase Increased — 13 reports (8.97%) Fatigue — 13 reports (8.97%) Muscle Spasms — 12 reports (8.28%) Pain In Extremity — 12 reports (8.28%) Acute Kidney Injury — 11 reports (7.59%) Arthralgia — 10 reports (6.9%) Muscular Weakness — 10 reports (6.9%)
Source database →
Simvastatin 40mg in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Simvastatin 40mg approved in United States?
Yes. FDA has authorised it.
Who is the marketing authorisation holder for Simvastatin 40mg in United States?
Marc Goodman is the originator. The local marketing authorisation holder may differ — check the official source linked above.