Tacrolimus Anhydrous: Side Effects, Uses & Monitoring
Facts extracted from current FDA product labeling for Tacrolimus Anhydrous. Educational only — not medical advice.
Reported adverse reactions
| Reaction | Highest frequency reported* |
|---|---|
| < 1 year | 9163% |
| ≥ 1 year | 2534% |
| ≥ 2 years | 475% |
| ≥ 3 years | 300% |
| Skin erythema | 28% |
| Fever | 21% |
| Cough increased | 18% |
| Skin infection | 16% |
| Allergic reaction | 13% |
| Asthma | 13% |
| Pharyngitis | 12% |
| Otitis media | 12% |
| Infection | 10% |
| Accidental injury | 8% |
| Pustular rash | 7% |
| Vomiting | 7% |
| Dry skin | 7% |
| Rhinitis | 6% |
| Urticaria | 6% |
| Lack of drug effect | 6% |
*Highest percentage across placebo-controlled trial tables summarized in current labeling.
Labeled uses
Tacrolimus 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. Tacrolimus ointment is not indicated for children younger than 2 years of age (see boxed WARNING , WARNINGS and PRECAUTIONS : Pediatric Use ).
Medical disclaimer: Always consult a qualified healthcare professional about any medication.