Pharmacologic class (EPC) · 13 drug pages

HMG-CoA reductase inhibitor: adverse event reports filed with FDA

204,462 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

204,462
reports across the class: 1% of all reports; 6,978
reports, 12 months to June 2026: 7,503 in the 12 months before; 74%
marked serious by the reporter: 57.4% across all reports; 13
drugs with a page: brand and generic names counted separately

HMG-CoA reductase inhibitor is a pharmacologic class (an FDA Established Pharmacologic Class) with 13 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 204,462 adverse event reports received by FDA, 1% of the database, from January 2004 to June 2026.

6,978 reports arrived in the 12 months to June 2026, close to the 7,503 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 74% of the class's reports are marked serious, 6.5% record death among the outcomes and 24.6% record hospitalisation, as reported.

Across the class the reactions recorded most often are myalgia (11.9%), type 2 diabetes mellitus (6.1%) and rhabdomyolysis (5.6%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
LipitorAtorvastatin calcium	brand	55,172	356	71.8%	Type 2 diabetes mellitus
CrestorRosuvastatin	brand	44,259	681	57.6%	Myalgia
Simvastatin	generic	35,501	1,032	88.7%	Myalgia
Rosuvastatin	generic	20,183	2,916	88.3%	Myalgia
Atorvastatin calcium	generic	20,120	595	69%	Myalgia
ZocorSimvastatin	brand	10,348	108	75%	Myalgia
Rosuvastatin calcium	generic	7,923	906	91.3%	Dyspnoea
Pravastatin sodium	generic	3,767	156	77.6%	Myalgia
Lovastatin	generic	1,972	30	66.5%	Myalgia
LivaloPitavastatin calcium	brand	1,799	30	46.9%	Myalgia
Fluvastatin	generic	1,421	61	79.6%	Myalgia
Fluvastatin sodium	generic	1,266	24	89.9%	Myalgia
Pitavastatin	generic	731	83	94.7%	Myalgia

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Myalgiamuscle pain11.9%24,414
Type 2 diabetes mellitustype 2 diabetes6.1%12,567
Rhabdomyolysismuscle breakdown5.6%11,415
Fatiguetiredness5.1%10,506
Arthralgiajoint pain5%10,172
Pain in extremitypain in an arm or leg4.8%9,845
Painpain, site not specified4.8%9,767
Drug interactionan interaction between medicines4.6%9,498
Dyspnoeashortness of breath4.6%9,348
Muscle spasmsmuscle cramps4.5%9,293
Drug hypersensitivityan allergic-type reaction to a medicine4.5%9,151
Drug ineffectivethe medicine did not work as expected4.4%8,987
Astheniaweakness or lack of energy4.2%8,618
Nauseafeeling sick4.1%8,355
Malaisegeneral feeling of being unwell4%8,152
Headachehead pain3.9%7,974
Muscular weaknessmuscle weakness3.7%7,592
Dizzinesslight-headedness or unsteadiness3.5%7,181
Diarrhoealoose or frequent stools3.2%6,561
Falla fall3%6,068
Vomitingbeing sick2.9%5,963
Blood creatine phosphokinase increased2.8%5,800
Off label useused for a purpose or in a way not on the label2.5%5,161
Myocardial infarctionheart attack2.5%5,103
Coughcough2.5%5,089

Solid bar: share of all class reports. Hollow bar: the median share across the 13 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death6.5%13,359

Life-threatening4.5%9,153

Hospitalisation (initial or prolonged)24.6%50,233

Disability6%12,310

Congenital anomaly0.4%759

Other serious54.4%111,163

Not serious26%53,144

Patient age

Under 20.1%117

2 to 110.1%121

12 to 170.1%235

18 to 443.7%7,590

45 to 6426.8%54,861

65 to 7419.8%40,409

75 and over16.2%33,028

Age not given33.3%68,101

Who reported

Physician23.5%48,019

Pharmacist5.7%11,614

Other health professional20.1%41,134

Lawyer5.7%11,589

Consumer or non-health professional35.7%72,927

Not given9.4%19,179

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about HMG-CoA reductase inhibitor reports

Which drugs are in the HMG-CoA reductase inhibitor class on this site?

Lipitor, Crestor, Simvastatin, Rosuvastatin, Atorvastatin calcium and Zocor and 7 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

204,462 reports through June 2026, 6,978 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

myalgia (11.9%), type 2 diabetes mellitus (6.1%), rhabdomyolysis (5.6%), fatigue (5.1%) and arthralgia (5%).

Can the members table be used to rank the drugs?

No. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.