Sirolimus Topical Side Effects

Medically reviewed by Drugs.com. Last updated on Mar 3, 2025.

Applies to sirolimus topical: topical application gel/jelly.

Precautions

It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood tests are needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for at least 12 weeks after the last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.

If your or your child's symptoms do not improve within 12 weeks of treatment, or if they become worse, check with your doctor.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, or unusual tiredness or weakness.

Check with your doctor right away if you have chest pain, cough, difficult breathing, fever, general feeling of discomfort or illness, or thickening of bronchial secretions. These may be symptoms of serious lung or breathing problems, including interstitial lung disease, pneumonitis, or pulmonary fibrosis.

This medicine may cause serious infections, including progressive multifocal leukoencephalopathy (PML). Check with your doctor if you have weakness on one side of the body, clumsiness, blurred vision, changes in thinking, memory problems, confusion, or personality changes.

This medicine may increase risk of cancer (eg, lymphoma, skin cancer). Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds. Wear protective clothing, including a hat and sunglasses.

While you are being treated with sirolimus topical gel, do not have any immunizations (live vaccines) without your doctor's approval.

This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.

Do not use this medicine for a skin problem that has not been checked by your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of sirolimus topical

Along with its needed effects, sirolimus topical may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking sirolimus topical:

For healthcare professionals

Applies to sirolimus topical: topical gel.

Dermatologic adverse events

• Very common (10% or more): Dry skin (40%), pruritus (17%)
• Common (1% to 10%): Acne, acneiform dermatitis, contact dermatitis, erythema, photosensitivity reaction, skin hemorrhage, skin irritation, solar dermatitis^[Ref]

Local

• Very common (10% or more): Application site irritation (37%)^[Ref]

Ocular

• Common (1% to 10%): Eye irritation, ocular hyperemia^[Ref]

See also:

Further information

Sirolimus topical side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer