MedDRA preferred term · muscle breakdown

Rhabdomyolysis: adverse event reports recording this term

40,803 reports to FDA record it, 2004–2026; 0.2% of the database.

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.

40,803
reports recording the term: 0.2% of all reports; 2,482
reports, 12 months to June 2026: 2,216 in the 12 months before; 99.1%
marked serious by the reporter: 57.4% across all reports; 10.4%
record death among outcomes, as reported: 9.1% across all reports

"Rhabdomyolysis" (in plain words, muscle breakdown) is a MedDRA preferred term recorded in 40,803 adverse event reports received by FDA, 0.2% of the database, from January 2004 to June 2026. The term is chosen by whoever codes the report to match what the reporter described.

2,482 reports recorded it in the 12 months to June 2026, up 12% from 2,216 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Of reports recording this term, 99.1% are marked serious, 10.4% include death among the outcomes and 68.9% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Simvastatin, Atorvastatin and Rosuvastatin. That order mostly follows how many reports each drug has overall; the table also gives the term's share within each drug's own reports. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

Reports by month, five years

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

Drugs listed as suspect products in these reports

Drug	Class	Reports with this term	Share of the drug's own reports
Simvastatin	HMG-CoA reductase inhibitor	3,659	10.3%
Atorvastatin	—	2,846	6.3%
Rosuvastatin	HMG-CoA reductase inhibitor	1,900	9.4%
Crestor	HMG-CoA reductase inhibitor	1,555	3.5%
Zocor	HMG-CoA reductase inhibitor	1,365	13.2%
Levetiracetam	—	1,123	2.2%
Lipitor	HMG-CoA reductase inhibitor	1,102	2%
Atorvastatin calcium	HMG-CoA reductase inhibitor	867	4.3%
Quetiapine	Atypical antipsychotic	834	1.6%
Olanzapine	Atypical antipsychotic	716	1.5%
Risperidone	Atypical antipsychotic	603	1.3%
Propofol	General anesthetic	548	2.9%
Acetaminophen	Nonsteroidal anti-inflammatory drug	529	0.6%
Furosemide	Loop diuretic	484	1%
Ticagrelor	P2Y12 platelet inhibitor	483	7.8%
Rosuvastatin calcium	HMG-CoA reductase inhibitor	481	6.1%
Metformin	Biguanide	456	0.7%
Omeprazole	Proton pump inhibitor	448	0.7%
Amlodipine	Calcium channel blocker	424	0.8%
Ezetimibe	Dietary cholesterol absorption inhibitor	416	3.6%
Lyrica	—	416	0.3%
Sertraline	Serotonin reuptake inhibitor	415	0.9%
Vytorin	Dietary cholesterol absorption inhibitor	414	11.4%
Colchicine	Alkaloid	405	4.7%
Clarithromycin	Macrolide antimicrobial	403	1.8%

Drugs with a page on this site, ordered by the number of their reports recording this term. The last column is the term's share within that drug's own reports, against 0.2% across the whole database. 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."

By pharmacologic class

Class	Reports with this term	Share of class reports	Median drug in class
HMG-CoA reductase inhibitor	11,415	5.6%	4.3%
Atypical antipsychotic	4,828	0.7%	0.5%
Serotonin reuptake inhibitor	1,950	0.7%	0.7%
Benzodiazepine	1,924	0.8%	0.6%
Nonsteroidal anti-inflammatory drug	1,760	0.3%	0%
Opioid agonist	1,546	0.2%	0%
Anti-epileptic agent	1,290	0.5%	0.4%
Proton pump inhibitor	1,239	0.3%	0.1%
Kinase inhibitor	1,117	0.1%	0%
Dietary cholesterol absorption inhibitor	1,098	4.7%	3.6%

Classes ordered by count. Class shares follow the class's overall report volume as much as anything else.

Patients in these reports

Patient age

Under 20.3%129

2 to 111.1%453

12 to 172.3%935

18 to 4418.8%7,674

45 to 6424.9%10,164

65 to 7416.3%6,648

75 and over15.9%6,508

Age not given20.3%8,292

Patient sex

Female34.6%14,104

Male54.8%22,377

Not given10.6%4,322

Grey bar: all 20,646,523 reports in the database. 30.9% of these reports give the United States as the country.

Questions about "Rhabdomyolysis"

What does "Rhabdomyolysis" mean in an adverse event report?

In plain language: muscle breakdown. It is a MedDRA preferred term, the dictionary FDA uses to code what a reporter described. The report's own description is not published by openFDA and is not shown here.

How many reports record rhabdomyolysis?

40,803 reports through June 2026 (0.2% of all reports), 2,482 of them in the latest 12 months.

Which drugs appear most often in these reports?

Simvastatin (3,659), Atorvastatin (2,846), Rosuvastatin (1,900), Crestor (1,555) and Zocor (1,365). Drugs with many reports overall lead almost every term's list. 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."

Does a drug appearing here mean it was responsible for this reaction?

No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

I have this symptom. What should I do?

This site cannot assess anyone. A pharmacist or clinician can; for an emergency, call the local emergency number. Nothing on this page is medical advice.

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. Terms are pooled across spelling and capitalisation variants of one MedDRA preferred term. 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.