Simvastatin
Hmg Coa Reductase Inhibitors
Sold as ZOCOR
- Drug class
- Hmg Coa Reductase Inhibitors
- Availability
- Prescription only
- Routes
- Oral
- Markets covered
- 3
- Products on record
- 210
- FDA reports (12 mo)
- 4,794
Overview
Simvastatin is an active pharmaceutical ingredient in the Hmg Coa Reductase Inhibitors group (C10AA). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 109 | May 29, 2026 |
| CA Canada | Health Canada | 76 | April 23, 2026 |
| US United States | FDA | 25 | March 23, 2026 |
GBUnited Kingdom· MHRA
109 products
Uses
g. g. LDL apheresis) or if such treatments are not appropriate. 1).
How to take
CACanada· Health Canada
76 products
Uses
APO-SIMVASTATIN (simvastatin tablets) is indicated in adults as an adjunct to diet for: • Reduction of risk of total mortality, myocardial infarction and ischemic stroke in patients with high risk of coronary events (because of existing Coronary Heart Disease (CHD), occlusive arterial disease, or diabetic over the age of 40) regardless of their lipid status.
• Slowing progression of coronary atherosclerosis, including reducing the development of new lesions and new total occlusions in hypercholesterolemic patients with CHD. 1 Pediatrics Pediatric Patients with Heterozygous Familial Hypercholesterolemia • 10 to <18 years of age APO-SIMVASTATIN is indicated as an adjunct to diet in adolescent boys and girls who are at least one year post-menarche aged 10 to <18 years to reduce total-C, LDL-C, TG, and Apo B levels with heterozygous familial hypercholesterolemia (HeFH).
1 Dosing Considerations). • < 10 years of age The safety and efficacy of pediatric patients under the age of 10 has not been established, therefore, Health Canada has not authorized an indication for pediatric patients under 10 years.
USUnited States· FDA
25 products
Uses
1 INDICATIONS AND USAGE Simvastatin tablets USP are indicated: To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events.
As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):
In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH).
As an adjunct to diet for the treatment of adults with:
Drug interactions
Known interactions involving Simvastatin. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 600. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL303060011
- [2]Health Canada (DPD) · 02247011 · revised March 22, 2025
- [3]FDA DailyMed · 00896fff-081d-45… · revised February 26, 2026 [PDF]
- [4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.