Tacrolimus Topical Side Effects

Medically reviewed by Drugs.com. Last updated on Jan 13, 2025.

Applies to tacrolimus topical: topical ointment.

Precautions

It is very important that your doctor check your or your child's progress at regular visits. This is to make sure the medicine is working properly and to check for unwanted effects. If your condition has not improved after 6 weeks or if they get worse, call your doctor.

This medicine may increase your risk of getting skin cancer or cancer of the lymph system (lymphoma). Talk to your doctor if you have concerns about this.

Stop using this medicine if signs and symptoms of eczema, such as itching, burning, stinging, rash, and redness go away, or as directed by your doctor.

This medicine may increase your risk of getting skin tumors, especially when exposed to sunlight. When you begin using this medicine:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible. Stay out of the sun even when the medicine is not on your skin.
• Wear protective clothing, including a hat. Also, wear sunglasses.
• Apply a sunblock product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your doctor.
• Apply a sun block lipstick that has an SPF of at least 15 to protect your lips.
• Make sure your doctor knows if you are receiving any type of UV light treatment or "phototherapy".
• Do not use a sunlamp or a tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor.

This medicine may cause you to be very sick if it is not used correctly. Call a doctor or poison control center right away if you accidentally swallow this medicine.

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.

Common side effects of tacrolimus topical

Some side effects of tacrolimus topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Serious side effects of tacrolimus topical

Along with its needed effects, tacrolimus 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 tacrolimus topical:

For healthcare professionals

Applies to tacrolimus topical: topical cream, topical ointment, topical solution.

Cardiovascular adverse events

• Common (1% to 10%): Lymphadenopathy, peripheral edema, hypertension
• Uncommon (0.1% to 1%): Tachycardia, syncope, valvular heart disease, vasodilation^[Ref]

Dermatologic

• Very common (10% or more): Skin burning (up to 58%), pruritus (up to 46%), erythema (up to 28%), skin infection (up to 16%)
• Common (1% to 10%):, Herpes simplex, pustular rash, folliculitis, urticaria, maculopapular rash, fungal dermatitis, acne, sunburn, skin disorder, vesiculobullous rash, skin tingling, face edema, dry skin, benign skin neoplasm, varicella zoster/herpes zoster, contact dermatitis, eczema herpeticum, cellulitis, Kaposi's varicelliform eruption, exfoliative dermatitis, rash, eczema, lice infestation, molluscum contagiosum, skin infection regardless of specific etiology,
• Uncommon (0.1% to 1%): Cutaneous moniliasis, furunculosis, leukoderma, seborrhea, skin carcinoma, skin discoloration, skin hypertrophy, skin ulcer, sweating, exacerbation of untreated area, alopecia, ecchymosis, nail disorder, photosensitivity reaction
• Postmarketing reports: Rosacea, bullous impetigo, Kaposi's varicelliform eruption, skin infection regardless of specific etiology, acne, lentigo^[Ref]

Endocrine

• Uncommon (0.1% to 1%): Hypothyroidism^[Ref]

Gastrointestinal

• Common (1% to 10%): Diarrhea, nausea, vomiting, abdominal pain, gastroenteritis, dyspepsia, periodontal abscess, tooth disorder, GI infection
• Uncommon (0.1% to 1%): Colitis, constipation, cramps, dehydration, dry mouth/nose, gastritis, GI disorder, hernia, mouth ulceration, rectal disorder, stomatitis, tooth caries, oral moniliasis^[Ref]

Genitourinary

• Common (1% to 10%): Urinary tract infection, dysmenorrhea
• Uncommon (0.1% to 1%): Cystitis, vaginal moniliasis, vaginitis, unintended pregnancy^[Ref]

Hematologic

• Uncommon (0.1% to 1%): Anemia^[Ref]

Hepatic

• Uncommon (0.1% to 1%): Bilirubinemia^[Ref]

Hypersensitivity

• Very common (10% or more): Allergic reaction (up to 13%)^[Ref]

Immunologic

• Very common (10% or more): Influenza-like illness (up to 34%)
• Common (1% to 10%): Infection, tonsillitis
• Uncommon (0.1% to 1%): Abscess, moniliasis, anaphylactoid reaction
• Postmarketing reports: Osteomyelitis, septicemia^[Ref]

Local

• Very common (10% or more): Application-site pruritus (17.5%), application-site impetigo (up to 11.5%), application-site burning (greater than 10%)
• Common (1% to 10%): Application-site folliculitis, application-site irritation, application-site infection, application-site papilloma, application-site warmth, application-site erythema, application-site pain, application-site irritation, application-site paresthesia, application-site rash
• Postmarketing reports: Application-site edema^[Ref]

Metabolic

• Common (1% to 10%): Alcohol intolerance
• Uncommon (0.1% to 1%): Anorexia, hypercholesterolemia^[Ref]

Musculoskeletal

• Common (1% to 10%): Back pain, myalgia, arthralgia
• Uncommon (0.1% to 1%): Arthritis, arthrosis, bone disorder, bursitis, chest pain, hypertonia, joint disorder, neck pain, tendon disorder^[Ref]

Nervous system

• Very common (10% or more): Headache (up to 20%)
• Common (1% to 10%): Hyperesthesia, paresthesia
• Uncommon (0.1% to 1%): Dizziness, migraine, taste perversion
• Postmarketing reports: Seizures^[Ref]

Ocular

• Common (1% to 10%): Conjunctivitis
• Uncommon (0.1% to 1%): Abnormal vision, blepharitis, conjunctival edema, dry eyes, eye pain, cataract NOS
• Postmarketing reports: Ophthalmic herpes infection^[Ref]

Oncologic

• Uncommon (0.1% to 1%): Benign breast neoplasm
• Postmarketing reports: Lymphomas, basal cell carcinoma, squamous cell carcinoma, malignant melanoma^[Ref]

Other

• Very common (10% or more): Fever (up to 21%), otitis media (up to 12%)
• Common (1% to 10%): Pain, asthenia, cyst, ear pain, accidental injury, lack of drug effect
• Uncommon (0.1% to 1%): Malaise, chills, ear disorder, edema, otitis externa, procedural complication, vertigo
• Postmarketing reports: Drug level increased^[Ref]

Psychiatric

• Common (1% to 10%): Insomnia, depression
• Uncommon (0.1% to 1%): Anxiety, abnormal thinking^[Ref]

Renal

• Postmarketing reports: Acute renal failure in patients with or without Netherton's syndrome, renal impairment

Respiratory

• Very common (10% or more): Cough (up to 18%), asthma (up to 13%), pharyngitis (up to 38.5%)
• Common (1% to 10%): Rhinitis, sinusitis, bronchitis, pneumonia, respiratory tract infection
• Uncommon (0.1% to 1%): Dyspnea, epistaxis, laryngitis, lung disorder^[Ref]

See also:

Further information

Tacrolimus 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