Where not to use tacrolimus ointment? Essential Patient Safety Information

Over 20 years of data show that topical tacrolimus (Protopic) has a well-established safety profile for atopic dermatitis, but like all effective medications, it requires proper application. It is vital to understand where not to use tacrolimus ointment and under which circumstances to ensure its safe and effective use.

Quick Summary

A guide to the specific areas and health conditions where tacrolimus ointment is contraindicated, including broken or infected skin, mucous membranes, and in young children. It covers key safety precautions, potential risks, and best practices for proper application.

Key Points

• Avoid Mucous Membranes: Never apply tacrolimus ointment to the eyes, inside the nose, or mouth due to risk of increased absorption and irritation.

• Do Not Use on Infected or Broken Skin: The ointment should not be used on open wounds, cuts, or active viral, bacterial, or fungal skin infections.

• Not for Children Under 2: Tacrolimus is contraindicated for use in children under two years of age.

• Limit Sun and UV Exposure: Patients should protect treated skin from natural and artificial sunlight due to a potential increased risk of skin tumors.

• Follow Specific Application Rules: Always apply a thin layer, never use occlusive dressings, and stop use once symptoms clear.

• Beware of Alcohol Interaction: Consuming alcohol may cause flushing and skin redness, especially on the face, while using tacrolimus.

• Serious Conditions Require Caution: Individuals with weakened immune systems or specific skin barrier disorders like Netherton's syndrome should not use this ointment.

Tacrolimus ointment is a non-steroidal prescription medication that works as a topical calcineurin inhibitor to treat moderate to severe atopic dermatitis (eczema) by reducing inflammation and itching. Due to its immunosuppressive effects on the skin and potential for absorption, it is crucial to use it correctly and be aware of situations where it should not be applied.

Areas of the Body to Exclude from Treatment

Tacrolimus ointment is strictly for external use on affected skin areas. Avoid applying it to:

Mucous Membranes and Sensitive Areas

Do not use the ointment on mucous membranes such as the inside of the nose, mouth, eyes, eyelids, or lips. Accidental contact should be followed by rinsing the area with water. Application to the anogenital area may also increase absorption and infection risk unless directed by a doctor.

Broken, Infected, or Pre-Malignant Skin

Tacrolimus should not be applied to open wounds, cuts, scrapes, or any skin with active bacterial, fungal, or viral infections, including cold sores or chickenpox. Any infection must be cleared before using tacrolimus. The ointment is also contraindicated on skin cancer or pre-cancerous lesions. Patients with conditions that compromise the skin barrier, such as Netherton's syndrome or erythroderma, are at higher risk of systemic absorption and should avoid tacrolimus.

Contraindicated Patient Groups

Children Under 2 Years Old

Tacrolimus ointment is not recommended for children younger than two years due to unknown long-term effects on the developing immune system and unestablished safety in this age group. For children aged 2 to 15, only the lower 0.03% strength is appropriate.

Immunocompromised Individuals

Patients with weakened immune systems from conditions like mononucleosis or other immunosuppressive treatments should not use tacrolimus.

Pregnancy and Breastfeeding

Pregnant and breastfeeding women should consult their doctor. While absorption is minimal, it's unknown if the drug passes into breast milk. If used topically, ensure the infant's skin doesn't touch treated areas.

Important Precautions for Use

Limiting Sun and UV Exposure

Avoid excessive natural sunlight and artificial UV light (sunlamps, tanning beds) while using tacrolimus. The medication may increase the risk of skin tumors with UV exposure. Use protective clothing, hats, and sunscreen.

Avoiding Occlusive Dressings

Do not cover treated skin with bandages or wraps, as this can increase systemic absorption. Loose clothing is fine.

Interaction with Alcohol

Drinking alcohol may cause temporary facial flushing or redness while using tacrolimus ointment.

Tacrolimus vs. Topical Corticosteroids: A Comparison

Tacrolimus is an alternative to topical corticosteroids for moderate-to-severe atopic dermatitis. Key differences include:

Feature	Tacrolimus Ointment	Topical Corticosteroids
Mechanism	Calcineurin inhibitor; modulates immune response	Steroid; reduces inflammation
Application Sites	Safe for sensitive skin areas like the face and neck	Often avoided on sensitive areas due to risk of skin thinning (atrophy)
Application Sensation	Can cause initial burning, stinging, or warmth that subsides	Typically less application-site irritation, but long-term issues possible
Skin Thinning	No risk of causing skin atrophy with long-term use	Can cause skin thinning with prolonged or inappropriate use
Long-Term Safety	Short-term and intermittent use is recommended, with a boxed warning regarding malignancy risk. Long-term data is still being evaluated, but many studies find no increased risk.	Associated risks include skin atrophy, telangiectasias, and bruising.

Conclusion

Understanding where not to use tacrolimus ointment is vital for safe and effective treatment of atopic dermatitis. Avoid mucous membranes, broken or infected skin, and use caution in specific patient groups like young children or those with compromised immune systems. Following precautions like limiting sun exposure and avoiding occlusive dressings is also important. Always follow medical advice for proper use.

Safe Usage Checklist

• Apply only to affected skin areas.
• Use a thin layer and rub in completely.
• Wash hands after use unless treating hands.
• Stop treatment when symptoms clear and follow your doctor's plan.
• Wait at least two hours before applying moisturizers.
• Protect treated skin from natural and artificial UV light.
• Inform your doctor if symptoms don't improve after 6 weeks or worsen.

Key Takeaways

• Avoid Mucous Membranes: Tacrolimus should not be applied to the eyes, inside the nose, or mouth due to risk of increased absorption and irritation.
• Broken Skin and Infections: Do not use on open wounds, cuts, or any active bacterial, fungal, or viral skin infections.
• Pediatric Warning: Tacrolimus ointment is contraindicated for use in children under two years of age.
• UV Protection: Avoid or limit sun exposure and do not use tanning beds or sun lamps during treatment.
• No Occlusive Dressings: Bandages or wraps should not be used over treated areas, as they increase systemic absorption.
• Alcohol Reaction: Be aware that alcohol consumption may cause skin flushing or redness while using tacrolimus.
• Systemic Absorption Concerns: Certain rare skin conditions like Netherton's syndrome or generalized erythroderma increase the risk of systemic absorption.

FAQs

Q: Can I use tacrolimus ointment on my eyelids? A: No, you should not use tacrolimus ointment on your eyelids or near your eyes. Contact with mucous membranes can cause irritation and increase systemic absorption.

Q: What should I do if I get tacrolimus ointment in my mouth? A: If you accidentally get tacrolimus ointment in your mouth, you should call your doctor and rinse your mouth out with water. Swallowing the ointment should be avoided.

Q: Can I put a bandage over the area treated with tacrolimus? A: No, you should not cover the treated area with bandages, dressings, or wraps, as this can increase the amount of medicine absorbed by your skin. Normal clothing is acceptable.

Q: My eczema is infected and blistering. Can I still use tacrolimus ointment? A: No, tacrolimus ointment should not be used on infected skin. The infection must be treated first, and the ointment should only be applied once the infection has cleared.

Q: Is tacrolimus ointment safe for a baby with severe eczema? A: No, tacrolimus ointment is not recommended for use in children under 2 years of age. Consult a pediatrician for appropriate alternative treatments for infants.

Q: Why do I need to avoid sun exposure while using tacrolimus? A: Tacrolimus may increase your sensitivity to UV light, which could potentially increase the risk of skin tumors. Limiting sun exposure and using protective clothing or sunscreen is advised.

Q: Can I drink alcohol while using tacrolimus ointment? A: It is best to avoid alcohol, as it can cause a flushing reaction where the face or treated skin areas become red and feel hot.

Citations

• MedlinePlus. Tacrolimus Topical: MedlinePlus Drug Information. July 20, 2024. Accessed October 12, 2025. https://medlineplus.gov/druginfo/meds/a602020.html
• Kaiser Permanente. tacrolimus 0.03 % topical ointment. May 15, 2025. Accessed October 12, 2025. https://healthy.kaiserpermanente.org/health-wellness/drug-encyclopedia/drug.tacrolimus-0-03-topical-ointment.248189
• DailyMed. Tacrolimus Ointment, 0.03% and 0.1% FOR .... Accessed October 12, 2025. https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=80e6817a-9b1e-4f0f-e053-2a91aa0a3d15
• Medscape. Protopic (tacrolimus ointment) dosing, indications, interactions .... Accessed October 12, 2025. https://reference.medscape.com/drug/protopic-tacrolimus-ointment-topical-343551
• MedlinePlus. Tacrolimus Topical: MedlinePlus Drug Information. July 20, 2024. Accessed October 12, 2025. https://medlineplus.gov/druginfo/meds/a602020.html
• Newcastle Hospitals NHS Foundation Trust. Topical Tacrolimus. November 01, 2022. Accessed October 12, 2025. https://www.newcastle-hospitals.nhs.uk/services/dermatology/patient-dermatology-information-leaflets/topical-tacrolimus/
• FDA. MEDICATION GUIDE PROTOPIC. Accessed October 12, 2025. https://www.fda.gov/media/74284/download
• National Institutes of Health (NIH). Management of Atopic Dermatitis: The Role of Tacrolimus. August 18, 2022. Accessed October 12, 2025. https://pmc.ncbi.nlm.nih.gov/articles/PMC9387362/
• National Institutes of Health (NIH). Long-term safety of tacrolimus ointment in atopic dermatitis. July 15, 2009. Accessed October 12, 2025. https://pubmed.ncbi.nlm.nih.gov/19435404/
• National Institutes of Health (NIH). Topical Tacrolimus and Alcohol-Induced Facial Flushing. October 09, 2023. Accessed October 12, 2025. https://pmc.ncbi.nlm.nih.gov/articles/PMC10631569/

Frequently Asked Questions

Can I use tacrolimus ointment on my face or neck?

Yes, unlike corticosteroids that can cause skin thinning, tacrolimus can be safely used on sensitive areas like the face and neck, but must be kept away from mucous membranes like eyes, mouth, and nose.

What if my skin becomes infected while I am using tacrolimus?

If your skin develops a bacterial, viral, or fungal infection, stop using tacrolimus ointment on that area immediately. Contact your doctor, as the infection needs to be treated first.

Why is there a warning about cancer risk with tacrolimus?

The FDA issued a boxed warning based on animal studies and rare human cases of malignancy. While a direct causal link has not been established in human studies, it is a precaution. To mitigate any potential risk, use is recommended to be short-term and intermittent, not continuous.

How long can I use tacrolimus ointment for?

Tacrolimus is intended for short-term and intermittent use, not for continuous long-term application. Your doctor will provide a specific treatment plan, which may involve breaks in treatment when symptoms resolve.

Do I need to stop using moisturizers when applying tacrolimus?

No, you can continue to use moisturizers, but you should apply them at least two hours after you have applied the tacrolimus ointment to avoid diluting the medication.

What is the appropriate strength for children aged 2-15?

For children between 2 and 15 years old, only the lower 0.03% strength of tacrolimus ointment is indicated. The 0.1% strength is reserved for adults and adolescents 16 and older.

What should I do if I have a skin barrier condition like Netherton's syndrome?

If you have a skin condition that compromises the skin barrier, such as Netherton's syndrome, you should not use tacrolimus due to the high risk of systemic absorption. Your doctor will recommend alternative therapies.