Tacrolimus: Side Effects, Uses & Monitoring

Facts extracted from current FDA product labeling for Tacrolimus. Educational only — not medical advice.

Reported adverse reactions

ReactionHighest frequency reported*
Less than 1 year9163%
Greater than or equal to 1 year2534%
Greater than or equal to 2 years475%
Greater than or equal to 3 years300%

*Highest percentage across placebo-controlled trial tables summarized in current labeling.

Labeled uses

PROTOPIC Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy  for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. PROTOPIC Ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGS and PRECAUTIONS : Pediatric Use ).

Source: FDA labeling via NIH DailyMed (set 3b7f0fed…). Not affiliated with FDA or NIH.

Medical disclaimer: Always consult a qualified healthcare professional about any medication.