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Protopic Side Effects

Generic Name: tacrolimus topical

Note: This document contains side effect information about tacrolimus topical. Some of the dosage forms listed on this page may not apply to the brand name Protopic.

In Summary

Common side effects of Protopic include: burning sensation of skin and pruritus. Other side effects include: herpes zoster infection, varicella zoster infection, and vesicobullous dermatitis. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to tacrolimus topical: topical ointment

Along with its needed effects, tacrolimus topical (the active ingredient contained in Protopic) 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

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

  • 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

  • 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

For Healthcare Professionals

Applies to tacrolimus topical: topical ointment

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, Deerfield, IL.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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.

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