No black box warning on record for Azithromycin

As of the latest FDA labeling reviewed, Azithromycin (azithromycin) does not carry a black box warning. Standard warnings and precautions still apply — see the full Azithromycin medicine page for the complete safety profile.

Other warnings & precautions

Cardiac Risk (QTc Prolongation): Azithromycin prolongs cardiac QTc interval and can cause fatal cardiac arrhythmias. FDA issued a safety communication in 2013. Risk is highest in patients with known QTc prolongation, hypokalemia, hypomagnesemia, bradycardia, or concurrent QTc-prolonging medicines. Assess cardiac risk before prescribing, especially in elderly and cardiac patients.
Hepatotoxicity: Abnormal liver function, hepatitis, cholestatic jaundice, hepatic necrosis, and hepatic failure have been reported. Discontinue azithromycin if signs of hepatic dysfunction occur.
Community-Acquired Pneumonia: In some patients with CAP, azithromycin monotherapy is appropriate; in others (high risk, hospitalized), combination with a beta-lactam is recommended per guidelines. Do not use azithromycin for CAP in areas with high macrolide resistance among S. pneumoniae.
Antibiotic Resistance: The widespread use of azithromycin has contributed to macrolide resistance. It should only be used when clinically indicated, not for viral infections.

No black box warning on record for Azithromycin

Other warnings & precautions

Cardiac Risk (QTc Prolongation): Azithromycin prolongs cardiac QTc interval and can cause fatal cardiac arrhythmias. FDA issued a safety communication in 2013. Risk is highest in patients with known QTc prolongation, hypokalemia, hypomagnesemia, bradycardia, or concurrent QTc-prolonging medicines. Assess cardiac risk before prescribing, especially in elderly and cardiac patients.
Hepatotoxicity: Abnormal liver function, hepatitis, cholestatic jaundice, hepatic necrosis, and hepatic failure have been reported. Discontinue azithromycin if signs of hepatic dysfunction occur.
Community-Acquired Pneumonia: In some patients with CAP, azithromycin monotherapy is appropriate; in others (high risk, hospitalized), combination with a beta-lactam is recommended per guidelines. Do not use azithromycin for CAP in areas with high macrolide resistance among S. pneumoniae.
Antibiotic Resistance: The widespread use of azithromycin has contributed to macrolide resistance. It should only be used when clinically indicated, not for viral infections.

Azithromycin Black Box Warning

No black box warning on record for Azithromycin

Other warnings & precautions

Azithromycin Black Box Warning

No black box warning on record for Azithromycin

Other warnings & precautions