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.

Some side effects of Protopic may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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

Dermatologic

Dermatologic effects have included skin burning (46% to 58%), pruritus (25% to 46%), skin erythema (12% to 28%), skin infection (5% to 12%), herpes simplex (4% to 12%), folliculitis (4% to 11%), pustular rash (3% to 6%), dry skin (3%), hyperesthesia (3% to 7%), urticaria (3% to 6%), skin tingling (2% to 8%), acne (2% to 7%), rash (2% to 5%), maculopapular rash (2% to 4%), vesiculobullous rash (2% to 4%), eczema (2% to 3%), sunburn (1% to 4%), skin disorder (1% to 4%), contact dermatitis (1% to 3%), exfoliative dermatitis (1% to 3%), fungal dermatitis (1% to 2%), eczema herpeticum (1% to 2%), benign skin neoplasm (1% to 2%), and varicella zoster/herpes zoster (1%). Other dermatologic side effects have included facial flushing, ecchymosis, cellulitis, skin discoloration, alopecia, angioedema, and sweating.

Oncologic

Oncologic side effects have included lymphoma and skin cancer. A definite causal relationship between these effects and tacrolimus topical (the active ingredient contained in Protopic) has not been clearly established.

As of December 2004, nineteen postmarketing cases of cancer in patients receiving treatment with tacrolimus topical have been reported to the FDA MedWatch program. Ten cases were reported as cutaneous tumors (7 at site of application), 9 cases as lymphomas, and the remaining as a variety of tumors (including squamous cell carcinoma, cutaneous sarcoma, and malignant melanoma). Three of these cases were reported to have occurred in children, with the remaining 16 cases reported in adults. In addition, 6 of the cases reported lymphadenopathy. The median time to diagnosis was 150 days (range 21 to 790 days) following initiation of treatment with tacrolimus topical. Two deaths were reported in adults and 8 patients were hospitalized (6 adults, 2 children). Causality has not been established.

Gastrointestinal

Gastrointestinal side effects have included diarrhea (3% to 4%), gastroenteritis (2% to 4%), nausea (1% to 4%), dyspepsia (1% to 4%), abdominal pain (1% to 3%), and vomiting (1%). Other gastrointestinal side effects have included taste perversion, anorexia, and constipation.

Musculoskeletal

Musculoskeletal side effects have included back pain (2% to 3%), asthenia (2% to 3%), and myalgia (1% to 3%). Other musculoskeletal side effects have included arthritis, arthralgia, and neck pain.

Respiratory

Respiratory side effects have included asthma (4% to 6%), pharyngitis (3% to 5%), rhinitis (3% to 5%), sinusitis (2% to 5%), bronchitis (2% to 3%), increased cough (1% to 3%), and pneumonia (1%). Other respiratory side effects have included dyspnea, hypoxia, and lung disorder.

Nervous system

Nervous system side effects have included headache (10% to 20%), and insomnia (1% to 4%). Other nervous system side effects have included dizziness, anxiety, migraine, neuritis, and paresthesia.

Metabolic

Metabolic side effects have included increased ALT, AST, increased creatinine, hyperglycemia, hypoglycemia, and bilirubinuria.

Ocular

Ocular side effects have included conjunctivitis (2% to 4%). Other ocular side effects have included eye pain and eye disorder.

Immunologic

Immunologic symptoms have included flu like symptoms (22% to 31%), infection (1% to 14%), fever (1% to 4%), lymphadenopathy (1% to 3%), and periodontal abscess (1% to 3%). Other immunologic side effects have included leukocytosis and leukopenia.

Cardiovascular

Cardiovascular side effects have included peripheral edema (2% to 4%). Other cardiovascular side effects have included angina pectoris, cerebrovascular accident, peripheral vascular disorder, arrhythmias, palpitations, hypertension, and vasodilation.

General

General side effects have included lack of drug effect (1% to 10%), accidental injury (3% to 6%), alcohol intolerance (2% to 7%), facial edema (1% to 3%), pain (1% to 4%), and cyst (1% to 3%). Other general side effects have included chills, and increased dehydration.

Other

Other side effects have included otitis media (1%) and ear pain.

Genitourinary

Genitourinary side effects have included dysmenorrhea (2% to 4%). Other genitourinary side effects have included unintended pregnancy and vaginal moniliasis.

Local

Local side effects have included exacerbation of the untreated area and postmarketing reports of application site edema.

Hepatic

Hepatic side effects have included liver function test abnormalities.

Psychiatric

Psychiatric side effects have included depression.

Hematologic

Hematologic side effects have included epistaxis.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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