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Tacrolimus topical Side Effects

Medically reviewed by Drugs.com. Last updated on Mar 16, 2023.

Applies to tacrolimus topical: topical ointment.

Warning

Topical route (Ointment)

Long-term safety of topical calcineurin inhibitors has not been established and rare cases of malignancy (eg, skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including tacrolimus ointment. Avoid continuous long-term use in any age group, and apply to limited areas of involvement with atopic dermatitis. Not indicated for use in children younger than 2 years of age. Only 0.03% tacrolimus ointment is indicated for use in children 2 to 15 years of age.

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:

Incidence not known

Other 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:

More common

Less common

For Healthcare Professionals

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

Cardiovascular

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 (26%), pruritus (22%), skin infection (12%)

Common (1% to 10%): Erythema, 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, cellulitis, Kaposi's varicelliform eruption

Uncommon (0.1% to 1%): Cutaneous moniliasis, furunculosis, leukoderma, seborrhea, skin carcinoma, skin discoloration, skin hypertrophy, skin ulcer, sweating, rosacea[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection, dysmenorrhea

Uncommon (0.1% to 1%): Breast neoplasm benign, cystitis, vaginal moniliasis, vaginitis

Frequency not reported: Unintended pregnancy[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, nausea, vomiting, abdominal pain, gastroenteritis, dyspepsia, periodontal abscess, tooth disorder, alopecia

Uncommon (0.1% to 1%): Colitis, constipation, cramps, dehydration, dry mouth/nose, gastritis, GI disorder, hernia, mouth ulceration, nail disorder, photosensitivity reaction, rectal disorder, stomatitis, tooth caries[Ref]

Endocrine

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

Hematologic

Uncommon (0.1% to 1%): Anemia, ecchymosis[Ref]

Hepatic

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

Immunologic

Very common (10% or more): Influenza-like illness (28%)

Common (1% to 10%): Infection

Uncommon (0.1% to 1%): Abscess, moniliasis, bullous impetigo, osteomyelitis,[Ref]

Hypersensitivity

Very common (10% or more): Allergic reaction (11%)[Ref]

Local

Uncommon (0.1% to 1%): Application site edema, application site burning, application site warmth, application site erythema, application site pain, application site irritation, application site paresthesia, application site rash[Ref]

Metabolic

Common (1% to 10%): Alcohol intolerance

Uncommon (0.1% to 1%): Anorexia, arthrosis, 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 (11%)

Common (1% to 10%): Hyperesthesia, paresthesia

Uncommon (0.1% to 1%): Dizziness, migraine, taste perversion[Ref]

Ocular

Common (1% to 10%): Conjunctivitis

Uncommon (0.1% to 1%): Abnormal vision, blepharitis, conjunctival edema, dry eyes, eye pain

Frequency not reported: Ophthalmic herpes infection[Ref]

Oncologic

Postmarketing reports: Lymphomas, basal cell carcinoma, squamous cell carcinoma, malignant melanoma[Ref]

Other

Common (1% to 10%): Otitis media, pain, asthenia, cyst, ear pain

Uncommon (0.1% to 1%): Malaise, chills, ear disorder, edema, otitis externa[Ref]

Psychiatric

Common (1% to 10%): Insomnia, depression

Uncommon (0.1% to 1%): Anxiety, thinking abnormal[Ref]

Respiratory

Common (1% to 10%): Cough, asthma, pharyngitis, rhinitis, sinusitis, bronchitis, pneumonia

Uncommon (0.1% to 1%): Dyspnea, epistaxis, laryngitis, lung disorder[Ref]

References

1. Product Information. Protopic (tacrolimus topical). Fujisawa. 2001;PROD.

2. Cerner Multum, Inc. UK Summary of Product Characteristics.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer