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Protopic

Last reviewed on RxList: 2/5/2019
Protopic Side Effects Center

Last reviewed on RxList 2/5/2019

Protopic (tacrolimus) is an immunosuppressant used to treat severe atopic dermatitis when other medications have not worked well. Common side effects of Protopic include:

  • stinging,
  • burning,
  • soreness,
  • redness, or
  • itching in the area of treated skin during the first few days of treatment.

Other side effects of Protopic include:

  • skin redness,
  • headache,
  • acne,
  • "hair bumps" (folliculitis),
  • acne,
  • stomach upset,
  • cold or flu-like symptoms (e.g., fever, chills, stuffy or runny nose, sneezing, sore throat, muscle aches), or
  • increased sensitivity of the skin to hot/cold/pain/touch.

Tell your doctor if you have unlikely but serious side effects of Protopic including:

Protopic ointment is applied to the affected areas of skin twice daily. It is available in strengths of 0.03% and 0.1%. Protopic may interact with cimetidine, erythromycin, antifungals, or heart medicines. Tell your doctor all medications you are taking. During pregnancy, Protopic should be used only when prescribed. This drug may pass into breast milk and may have undesirable effects on a nursing infant. Breastfeeding is not recommended while using this drug.

Our Protopic (tacrolimus) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Eczema (also atopic eczema or atopic dermatitis) is a general medical term for many types of skin inflammation. See Answer
Protopic Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using tacrolimus and call your doctor at once if you have a serious side effect such as:

  • severe stinging, burning, itching, or soreness where the medicine is applied;
  • swollen glands;
  • redness or crusting around your hair follicles; or
  • signs of a skin infection (redness, swelling, itching, oozing).

Less serious side effects may include:

  • mild burning, stinging, or itching;
  • skin redness;
  • acne;
  • cold or flu symptoms such as stuffy nose, sneezing, sore throat;
  • headache; or
  • feeling more sensitive to hot or cold temperatures.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Protopic (Tacrolimus)

SLIDESHOW

Rosacea, Acne, Shingles: Common Adult Skin Diseases See Slideshow
Protopic Professional Information

SIDE EFFECTS

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 (%)
Adult Pediatric Adult Pediatric Total
Vehicle
(n=212)
%
0.03% Tacrolimus Ointment
(n=210)
%
0.1% Tacrolimus Ointment
(n=209)
%
Vehicle
(n=116)
%
0.03% Tacrolimus Ointment
(n=118)
%
(n=4682)
%
(n=4481)
%
(n=9163)
%
Skin Burning† 26 46 58 29 43 28 20 24
Pruritus† 37 46 46 27 41 25 19 22
Flu-like symptoms† 19 23 31 25 28 22 34 28
Allergic Reaction 8 12 6 8 4 9 13 11
Skin Erythema 20 25 28 13 12 12 7 9
Headache† 11 20 19 8 5 13 9 11
Skin Infection 11 12 5 14 10 9 16 12
Fever 4 4 1 13 21 2 14 8
Infection 1 1 2 9 7 6 10 8
Cough Increased 2 1 1 14 18 3 10 6
Asthma 4 6 4 6 6 4 13 8
Herpes Simplex 4 4 4 2 0 4 3 3
Eczema Herpeticum 0 1 1 0 2 0 0 0
Pharyngitis 3 3 4 11 6 4 12 8
Accidental Injury 4 3 6 3 6 6 8 7
Pustular Rash 2 3 4 3 2 2 7 5
Folliculitis† 1 6 4 0 2 4 2 3
Rhinitis 4 3 2 2 6 2 4 3
Otitis Media 4 0 1 6 12 2 11 6
Sinusitis† 1 4 2 8 3 6 7 6
Diarrhea 3 3 4 2 5 2 4 3
Urticaria 3 3 6 1 1 3 4 4
Lack of Drug Effect 1 1 0 1 1 6 6 6
Bronchitis 0 2 2 3 3 4 4 4
Vomiting 0 1 1 7 6 1 4 3
Maculopapular Rash 2 2 2 3 0 2 1 1
Rash† 1 5 2 4 2 2 3 3
Abdominal Pain 3 1 1 2 3 1 3 2
Fungal Dermatitis 0 2 1 3 0 2 4 3
Gastroenteritis 1 2 2 3 0 2 4 3
Alcohol Intolerance† 0 3 7 0 0 4 0 2
Acne† 2 4 7 1 0 3 2 3
Sunburn 1 2 1 0 0 2 1 1
Skin Disorder 2 2 1 1 4 2 2 2
Conjunctivitis 0 2 2 2 1 3 3 3
Pain 1 2 1 0 1 2 1 2
Vesiculobullous Rash† 3 3 2 0 4 2 1 1
Lymphadenopathy 2 2 1 0 3 1 2 1
Nausea 4 3 2 0 1 2 1 2
Skin Tingling† 2 3 8 1 2 2 1 1
Face Edema 2 2 1 2 1 1 1 1
Dyspepsia† 1 1 4 0 0 2 2 2
Dry Skin 7 3 3 0 1 1 1 1
Hyperesthesia† 1 3 7 0 0 2 0 1
Skin Neoplasm Benign‡‡ 1 1 1 0 0 1 2 2
Back Pain† 0 2 2 1 1 3 0 2
Peripheral Edema 2 4 3 0 0 2 0 1
Varicella Zoster/Herpes Zoster† ‡ 0 1 0 0 5 1 2 2
Contact Dermatitis 1 3 3 3 4 2 2 2
Asthenia 1 2 3 0 0 1 0 1
Pneumonia 0 1 1 2 0 1 3 2
Eczema 2 2 2 0 0 1 0 1
Insomnia 3 4 3 1 1 2 0 1
Exfoliative Dermatitis 3 3 1 0 0 0 1 0
Dysmenorrhea 2 4 4 0 0 2 1 1
Periodontal Abscess 1 0 1 0 0 1 1 1
Myalgia† 0 3 2 0 0 2 1 1
Cyst† 0 1 3 0 0 1 0 1
Cellulitis 1 1 1 0 0 1 1 1
Exacerbation of Untreated Area 1 0 1 1 0 1 1 1
Procedural Complication 1 0 0 1 0 1 1 1
Hypertension 0 0 1 0 0 2 0 1
Tooth Disorder 0 1 1 1 0 2 1 1
Arthralgia 1 1 3 2 0 2 1 2
Depression 1 2 1 0 0 1 0 1
Paresthesia 1 3 3 0 0 2 1 2
Alopecia 0 1 1 0 0 1 1 1
Urinary Tract Infection 0 0 1 0 0 2 1 2
Ear Pain 1 0 1 0 1 0 1 1
† 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, abscess, anaphylactoid reaction, anemia, anorexia, anxiety, arthritis, arthrosis, bilirubinemia, blepharitis, bone disorder, breast neoplasm benign, bursitis, cataract NOS, chest pain, chills, colitis, conjunctival edema, constipation, cramps, cutaneous moniliasis, cystitis, dehydration, dizziness, dry eyes, dry mouth/nose, dyspnea, ear disorder, ecchymosis, edema, epistaxis, eye pain, furunculosis, gastritis, gastrointestinal disorder, hernia, hypercholesterolemia, hypertonia, hypothyroidism, joint disorder, laryngitis, leukoderma, lung disorder, malaise, migraine, moniliasis, mouth ulceration, nail disorder, neck pain, neoplasm benign, oral moniliasis, otitis externa, photosensitivity reaction, rectal disorder, seborrhea, skin carcinoma, skin discoloration, skin hypertrophy, skin ulcer, stomatitis, tendon disorder, thinking abnormal, tooth caries, sweating, syncope, tachycardia, taste perversion, unintended pregnancy, vaginal moniliasis, vaginitis, valvular heart disease, vasodilatation, and vertigo.

Post-Marketing Events

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.

CNS

Seizures

Infections

Bullous impetigo, osteomyelitis, septicemia

Neoplasms

Lymphomas, basal cell carcinoma, squamous cell carcinoma, malignant melanoma

Renal

Acute renal failure in patients with or without Netherton's syndrome, renal impairment

Skin

Rosacea, application site edema

Read the entire FDA prescribing information for Protopic (Tacrolimus)

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