Tacrolimus Topical Side Effects

Medically reviewed by Drugs.com. Last updated on Dec 15, 2024.

Applies to tacrolimus topical: topical ointment.

Important warnings This medicine can cause some serious health issues

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.

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:

More common side effects

• cough
• fever
• general aches and pains
• headache
• itching skin—in children
• loss of appetite
• skin burning
• skin flushing in areas of ointment application when drinking alcohol
• sneezing
• weakness

Less common side effects

• acid or sour stomach
• acne
• back pain
• belching
• burning, itching, or pain in hairy areas
• chills
• cyst
• flushing
• heartburn
• increased sensitivity to sunlight
• increased skin sensitivity
• indigestion
• itching eyes
• joint pain
• muscle aches or pain
• pain in the eye
• pain or tenderness around the eyes and cheekbones
• pus at root of the hair
• rash
• redness in the eye
• runny nose
• severe skin rash or hives
• skin blisters—in children
• skin tingling
• stomach discomfort, upset, or pain
• stuffy nose
• swelling of the eye, eyelid, or inner lining of the eyelid
• swollen glands
• tightness of the chest
• troubled breathing or wheezing
• watery eyes

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

• agitation
• black, tarry stools
• bloody urine
• burning or stinging sensation of the face
• change in size, shape, or color of an existing mole
• coma
• confusion
• convulsions
• decreased frequency or amount of urine
• depression
• fever
• general feeling of illness
• growth or bump on skin
• hostility
• increase in bone pain
• increased blood pressure
• increased thirst
• irritability
• lethargy
• looks very ill
• loss of appetite
• loss of bladder control
• lower back or side pain
• mole that leaks fluid or bleeds
• muscle spasm or jerking of all extremities
• muscle twitching
• nausea
• new mole
• rapid weight gain
• red rash with watery, yellow-colored, or pus filled blisters
• redness of the face
• seizures
• small, red skin lesion, growth, or bump usually on the face, ears, neck, hands, or arms
• sore that will not heal
• spider-like blood vessels on the face
• stupor
• sudden loss of consciousness
• swelling of the face, ankles, lower legs, hands, or fingers
• swollen glands
• thick, yellow to honey-colored crusts
• unusual tiredness or weakness
• vomiting
• weight gain
• weight loss
• yellow skin and eyes

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 (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]

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