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Protopic (Tacrolimus Topical) - Summary



Long-term Safety of Topical Calcineurin Inhibitors Has Not Been Established

Although a causal relationship has not been established, rare cases of malignancy (e.g., skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including PROTOPIC Ointment.


  • Continuous long-term use of topical calcineurin inhibitors, including PROTOPIC Ointment, in any age group should be avoided, and application limited to areas of involvement with atopic dermatitis.
  • PROTOPIC Ointment is not indicated for use in children less than 2 years of age. Only 0.03% PROTOPIC Ointment is indicated for use in children 2-15 years of age.


PROTOPIC (tacrolimus) Ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only.

PROTOPIC Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy  for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable.

PROTOPIC Ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGS and PRECAUTIONS: Pediatric Use).

See all Protopic indications & dosage >>


Published Studies Related to Protopic (Tacrolimus Topical)

Pimecrolimus vs. tacrolimus for the topical treatment of unresponsive oral erosive lichen planus: a 8 week randomized double-blind controlled study. [2014]
CONCLUSION: Both medications would currently appear to be a treatment of choice

Topical tacrolimus significantly promotes repigmentation in idiopathic guttate hypomelanosis: a double-blind, randomized, placebo-controlled study. [2013]
compared with placebo in the treatment of IGH... CONCLUSION: Topical 0.1% tacrolimus ointment appeared to be an effective and safe

A comparative study in efficacy and safety of 0.1% tacrolimus and 0.05% clobetasol propionate ointment in discoid lupus erythematosus by modified cutaneous lupus erythematosus disease area and severity index. [2012]
CONCLUSION: The present study proved the efficacy of twice-daily tacrolimus and

Single-blind, randomized controlled trial evaluating the treatment of facial seborrheic dermatitis with hydrocortisone 1% ointment compared with tacrolimus 0.1% ointment in adults. [2011.11.17]
BACKGROUND: Tacrolimus is a topical calcineurin inhibitor with immunomodulatory, anti-inflammatory, and fungicidal properties that may be beneficial in the treatment of facial seborrheic dermatitis. OBJECTIVES: We sought to compare the efficacy and safety of tacrolimus with standard corticosteroid treatment in adults with facial seborrheic dermatitis in a phase II, single-blind, randomized controlled trial... CONCLUSION: Tacrolimus 0.1% ointment required significantly fewer applications compared with hydrocortisone 1% ointment to achieve a comparable clinical response in adults with facial seborrheic dermatitis. Tacrolimus was generally well tolerated. Copyright (c) 2011 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.

A double-blind, randomized, placebo-controlled trial of topical tacrolimus 0.1% vs. clobetasol propionate 0.05% in childhood vitiligo. [2011.09]
BACKGROUND: Both clobetasol propionate 0.05% (CP 0.05%) and tacrolimus 0.1% (T 0.1%) ointments have been shown to be efficacious and safe in treating vitiligo in the paediatric population. OBJECTIVES: To assess efficacy and safety of these two therapies compared with each other and with placebo... CONCLUSIONS: Both CP 0.05% and T 0.1% ointments offer similar benefit in paediatric vitiligo, both facial and nonfacial. The facial lesions responded faster than the nonfacial ones. (c) 2011 The Authors. BJD (c) 2011 British Association of Dermatologists.

more studies >>

Clinical Trials Related to Protopic (Tacrolimus Topical)

Efficacy and Safety of Concentration-controlled Everolimus to Eliminate or to Reduce Tacrolimus Compared to Tacrolimus in de Novo Liver Transplant Recipients [Completed]
This trial was designed to address important issues that impact recipients of liver allografts as well as clinicians, ie, renal function, reduction or discontinuation of tacrolimus early post-transplantation, and progression rate of fibrosis in hepatitis C virus (HCV) positive patients.

A Multicenter Study in Liver Transplant Patients Converted From Prograf� to Advagraf� During the First Post-transplantation Year [Recruiting]
A study in which two groups of patients will be analysed; patients converted from Prograf to Advagraf within the first 3 months after transplantation and patients converted from Prograf to Advagraf between 3 months and 1 year after transplantation.

Pharmacokinetic Studies of Tacrolimus in Transplant Patients [Completed]
The study is designed to compare the steady-state pharmacokinetics of Prograf (Brand) and the two most disparate generic formulations (Generic Hi and Generic Lo) in a fully replicated, 3-way cross-over study in stable kidney (n=36) and liver transplant (n=36) subjects.

A Study of Renal Transplant Patients Converted From the Twice Per Day Form of Tacrolimus (Prograf) to the Once Per Day Form (Advagraf) [Recruiting]
Assessment in a real situation of the conversion conditions, the efficacy and the safety of the treatment with tacrolimus in renal transplant patients converted from the tacrolimus twice per day form (Prograf) to the tacrolimus once per day form (Advagraf) with follow-up at one year. Analysis of two groups of patients: patients converted from Prograf to Advagraf early (during the first 6 months post-transplantation) or late (between 6 and 12 months post-transplantation).

A Study to Assess the Pharmacokinetics, Safety and Efficacy of Advagraf and Prograf in de Novo Liver Transplantation [Recruiting]

more trials >>

Reports of Suspected Protopic (Tacrolimus Topical) Side Effects

OFF Label USE (26)Mycosis Fungoides (5)Maternal Exposure During Pregnancy (5)Headache (4)Myocardial Infarction (4)Blood Potassium Decreased (4)Drug Ineffective (3)Pain (3)Fall (3)Gastrooesophageal Reflux Disease (3)more >>


Based on a total of 8 ratings/reviews, Protopic has an overall score of 5. The effectiveness score is 6.50 and the side effect score is 6.25. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.

Protopic review by 42 year old female patient

Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
Treatment Info
Condition / reason:   eczema
Dosage & duration:   pearl size (dosage frequency: twice daily) for the period of 3 months
Other conditions:   none
Other drugs taken:   none
Reported Results
Benefits:   cleared up chronic eczema. Especially effective on elbows and legs.
Side effects:   I did not experience side effects all though I was warned to avoid exposing treated area to sunlight.
Comments:   I was told to use this once in the morning and once before going to bed. I had to use it on clean skin, and to make sure ointment fully absorbed. I started to see improvements within days. I was warned that I might have recurrence of eczema after a few months, but I didn't.


Protopic review by 37 year old female patient

Overall rating:  
Effectiveness:   Moderately Effective
Side effects:   Severe Side Effects
Treatment Info
Condition / reason:   eczema
Dosage & duration:   apply twice daily (dosage frequency: twice daily) for the period of 2 months
Other conditions:   made the itch worse
Other drugs taken:   none
Reported Results
Benefits:   none - the benefit was supposed to be due to the fact that it wasn't a steroid cream
Side effects:   burning and itching worse than the eczema - I'd have to race to the shower and wash off remaining product - it was terrible
Comments:   apply twice daily but I'd have to wash it off w/in an hour because it burned so badly


Protopic review by 18 year old female patient

Overall rating:  
Effectiveness:   Ineffective
Side effects:   Moderate Side Effects
Treatment Info
Condition / reason:   Vaginal Eczema
Dosage & duration:   apply 2/day (dosage frequency: once) for the period of One day
Other conditions:   none
Other drugs taken:   Allegra
Reported Results
Benefits:   none
Side effects:   IT BURNS SO BAD!!!!!! ITCHING AND BURNING LIKE MY WORST ECZEMA NIGHTMARE! LIKE A HEATING PAD HAS BEEN LEFT ON MY BARE SKIN ON HIGH HEAT FOR A LONG TIME. I paid over $100 for this and I don't think I can go through with this to see if it gets better. Not twice a day, I'm miserable right now from putting on for the first time this morning - 2 hours ago and it still is hurting, burning, itching, on fire! I'd take caution when applying this, only do a very small area and do it when you don't have to work or go to school. FML
Comments:   Absolutely not following through with it.

See all Protopic reviews / ratings >>

Page last updated: 2014-12-01

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