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What is Protopic (tacrolimus ointment)?
Atopic dermatitis is a chronic skin disease in which the skin becomes inflamed, causing itchiness, redness, swelling, cracking, weeping, crusting, and scaling. The inflammation is caused by activation of the immune system though the reason for the activation is unknown.
Protopic suppresses the immune system and the inflammation by inhibiting an enzyme (calcineurin) crucial for the multiplication of T-cells, cells that are required for activation of the immune system.
Common side effects of Protopic include:
Serious side effects of Protopic include:
No studies have been done to determine if Protopic has important interactions with other drugs. Interactions are unlikely because only small amounts of Protopic are absorbed from the skin; however, it is possible that important interactions might occur. Only small amounts of Protopic are absorbed from the ointment, and it is not known if these amounts are toxic to a fetus.
Among women who have received oral tacrolimus while pregnant, high potassium levels and kidney injury have been reported in their newborns. Protopic should be used during pregnancy only if the benefits outweigh the potential risks to the fetus.
Only small amounts of Protopic are absorbed from the ointment, and it is not known how much, if any, appears in breast milk. Tacrolimus, when taken orally, passes into breast milk. Consideration should be given to discontinuing either breastfeeding or Protopic in nursing mothers.
What are the important side effects of Protopic (tacrolimus ointment)?
The most common side effects of tacrolimus ointment are skin reactions at the site of use, including:
Continuous long-term use of tacrolimus should be avoided because rare cases of skin cancer and lymphoma have occurred during tacrolimus treatment.
Protopic (tacrolimus ointment) side effects list for healthcare professionals
No phototoxicity and no photoallergenicity were detected in clinical studies with 12 and 216 normal volunteers, respectively. One out of 198 normal volunteers showed evidence of sensitization in a contact sensitization study.
In three 12 week randomized vehicle-controlled studies and four safety studies, 655 and 9,163 patients respectively, were treated with Protopic Ointment. The duration of follow-up for adult and pediatric patients in the safety studies is tabulated below.
Duration of Follow-up in Four Open-label Safety Studies
|Time on Study||Adult||Pediatrics||Total|
|< 1 year||4682||4481||9163|
|≥ 1 year||1185||1349||2534|
|≥ 2 years||200||275||475|
|≥ 3 years||118||182||300|
The following table depicts the adjusted incidence of adverse events pooled across the 3 identically designed 12-week controlled studies for patients in vehicle, Protopic Ointment 0.03%, and Protopic Ointment 0.1% treatment groups. The table also depicts the unadjusted incidence of adverse events in four safety studies, regardless of relationship to study drug.
Incidence of Treatment Emergent Adverse Events
|12-Week, Randomized, Double-Blind, Phase 3 Studies|
12-Week Adjusted Incidence Rate (%)
|Open-Label Studies (up to 3 years) 0.1% and 0.03%|
Tacrolimus Ointment Incidence Rate (%)
|0.03% Tacrolimus Ointment|
|0.1% Tacrolimus Ointment|
|0.03% Tacrolimus Ointment|
|Lack of Drug Effect||1||1||0||1||1||6||6||6|
|Skin Neoplasm Benign‡‡||1||1||1||0||0||1||2||2|
|Varicella Zoster/Herpes Zoster† ‡||0||1||0||0||5||1||2||2|
|Exacerbation of Untreated Area||1||0||1||1||0||1||1||1|
|Urinary Tract Infection||0||0||1||0||0||2||1||2|
|† May be reasonably associated with the use of this drug product|
‡ All the herpes zoster cases in the pediatric 12-week study and the majority of cases in the open-label pediatric studies were reported as chicken pox.
‡‡ Generally “warts”.
Other adverse events which occurred at an incidence between 0.2% and less than 1% in clinical studies in the above table include:
- abnormal vision,
- anaphylactoid reaction,
- bone disorder,
- breast neoplasm benign,
- cataract NOS,
- chest pain,
- conjunctival edema,
- cutaneous moniliasis,
- dry eyes,
- dry mouth/nose,
- ear disorder,
- eye pain,
- gastrointestinal disorder,
- joint disorder,
- lung disorder,
- mouth ulceration,
- nail disorder,
- neck pain,
- neoplasm benign,
- oral moniliasis,
- otitis externa,
- photosensitivity reaction,
- rectal disorder,
- skin carcinoma,
- skin discoloration,
- skin hypertrophy,
- skin ulcer,
- tendon disorder,
- thinking abnormal,
- tooth caries,
- taste perversion,
- unintended pregnancy,
- vaginal moniliasis,
- valvular heart disease,
- vasodilatation, and
The following adverse reactions have been identified during postapproval use of Protopic Ointment. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Acute renal failure in patients with or without Netherton's syndrome, renal impairment
Rosacea, application site edema
What drugs interact with Protopic (tacrolimus ointment)?
Formal topical drug interaction studies with Protopic Ointment have not been conducted. Based on its extent of absorption, interactions of Protopic Ointment with systemically administered drugs are unlikely to occur but cannot be ruled out. The concomitant administration of known CYP3A4 inhibitors in patients with widespread and/or erythrodermic disease should be done with caution.
Some examples of such drugs are:
Protopic (tacrolimus ointment) is an immunosuppressant topical drug (applied to the skin) used to treat atopic dermatitis (eczema). Common side effects of Protopic include redness, burning, itching, flu-like symptoms, allergic reactions, and headache. Serious side effects of Protopic include rare cases of skin cancer and lymphoma due to continuous long-term use. Among women who have received oral tacrolimus while pregnant, high potassium levels and kidney injury have been reported in their newborns. Protopic should be used during pregnancy only if the benefits outweigh the potential risks to the fetus. Only small amounts of Protopic are absorbed from the ointment, and it is not known how much, if any, appears in breast milk.
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Related Disease Conditions
Eczema refers to skin inflammation. There are many different types of eczema that produce symptoms and signs that range from oozing blisters to crusty plaques of skin. Treatment varies depending upon the type of eczema the person has.
Is Eczema Contagious?
Eczema is a skin condition characterized by inflamed, rough skin patches that occasionally produce fluid-filled bumps that may ooze. There is no cure for eczema, though eczema may be treated with moisturization, eczema cream, and topical steroids.
Ringworm vs. Eczema
While ringworm is a fungal infection, and eczema is a skin condition, both are characterized by itchiness. Eczema patches are leathery while ringworm involves ring formation on the skin. Over-the-counter antifungals treat ringworm. Topical creams and ointments treat eczema.
Atopic Dermatitis vs. Eczema
Atopic dermatitis and eczema both refer to skin conditions. Atopic dermatitis is a cause of eczema, which refers to skin conditions that cause inflammation and irritation. The terms are sometimes used interchangeably. Eczema is not a condition in itself, but a description for a group of skin diseases that cause skin inflammation and irritation.
Treatment & Diagnosis
Medications & Supplements
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.