Table 3.

A summary of the 11 case reports in VigiBase of azithromycin–statin and rhabdomyolysis for which a drug interaction was suggested by the reporter

Case	Sex	Age	Drugs	Other information
1	M	–	Azithromycin	Uncertainty whether atorvastatin or gemfibrozil was concomitantly used with azithromycin
			Atorvastatin
2	M	–	Azithromycin 500 mg (1 day) 250 mg (4 days)	Both drugs were discontinued. Outcome unknown
			Atorvastatin 20 mg (2 years)
3	M	41	Azithromycin	Atorvastatin levels were increased, although no plasma levels were given. Pharmacokinetic interaction related to CYP activity is discussed in the narrative text
			Atorvastatin 40 mg
4	F	66	Azithromycin	The reporter stated: multifactor cause of rhabdomyolysis including renal dysfunction, use of azithromycin–atorvastatin and viral infection. Pharmacokinetic interaction due to CYP activity is discussed in the narrative text
			Atorvastatin 80 mg (3 years)
			Nicotinic acid
5	M	56	Azithromycin	Atorvastatin and azithromycin discontinued. Patient recovered. Uncertainty whether atorvastatin or gemfibrozil was concomitantly used with azithromycin
			Atorvastatin
			Gemfibrozil
6	F	43	Azithromycin (9 days)	The patient recovered
			Cerivastatin 1 dosage form (4 years)
7	M	51	Azithromycin
			Lovastatin
8	M	56	Azithromycin (5 days)	Simvastatin was increased from 40 to 80 mg day–1 since the LDL was elevated. Three weeks later the cholesterol was well controlled. The patient was then started on fexofenadine and AZ. Simvastatin, temazepam, nefazodone, isometheptene and fexofenadine were discontinued. The condition started to improve. In the report nefazodone was primarily suspected to be the culprit. However, it was not possible to exclude the contributing factor of azithromycin, since the ADR occurred 5 days after introduction of azithromycin
			Simvastatin 80 mg (4 weeks)
			Temazepam
			Nefazodone
			Isometheptene
			Fexofenadine (5 days)
9	M	–	Azithromycin
			Simvastatin
10	M	48	Azithromycin (7 days)	Patient with diabetes mellitus, coronary artery disease, cardiomyopathy and history of renal failure secondary to diabetes (transplantation 15 years ago). Azithromycin was introduced; a week later the patient was admitted to hospital for acute renal failure, rhabdomyolysis and hepatic insufficiency. It was determined that the acute renal failure was due to rhabdomyolysis, which was caused by the combination of simvastatin and azithromycin. Simvastatin was discontinued. Hepatic insufficiency and rhabdomyolysis revealed, but renal failure persisted
			Simvastatin
11	F	74	Azithromycin (13 days)	Three days after a 10-day course of azithromycin the patient developed muscle pain. Pravastatin was discontinued and the symptoms resolved. Pharmacokinetic interaction due to CYP activity is discussed in the narrative. The reporter requested if a change in product information was adequate
			Pravastatin 20 mg (2 years)

Time intervals listed within parentheses state the duration of drug therapy prior to onset of rhabdomyolysis occurrence.