No black box warning on record for Amoxicillin

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

Other warnings & precautions

Penicillin Allergy: Obtain complete allergy history before prescribing. Cross-reactivity with cephalosporins exists (~1–2% risk in penicillin-allergic patients for true IgE-mediated allergy).
Superinfection: Prolonged use may result in overgrowth of resistant organisms including C. difficile.
Mononucleosis Rash: Patients with infectious mononucleosis (Epstein-Barr virus) who receive amoxicillin/ampicillin develop a characteristic maculopapular rash in >80% of cases. This is not a true penicillin allergy.
C. difficile: Consider CDAD in patients presenting with diarrhea during or after treatment.

No black box warning on record for Amoxicillin

Other warnings & precautions

Penicillin Allergy: Obtain complete allergy history before prescribing. Cross-reactivity with cephalosporins exists (~1–2% risk in penicillin-allergic patients for true IgE-mediated allergy).
Superinfection: Prolonged use may result in overgrowth of resistant organisms including C. difficile.
Mononucleosis Rash: Patients with infectious mononucleosis (Epstein-Barr virus) who receive amoxicillin/ampicillin develop a characteristic maculopapular rash in >80% of cases. This is not a true penicillin allergy.
C. difficile: Consider CDAD in patients presenting with diarrhea during or after treatment.

Amoxicillin Black Box Warning

No black box warning on record for Amoxicillin

Other warnings & precautions

Amoxicillin Black Box Warning

No black box warning on record for Amoxicillin

Other warnings & precautions