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Protopic

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Protopic

Protopic Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Protopic (tacrolimus) is used to treat severe atopic dermatitis when other medications have not worked well. It is an immunosuppressant. Common side effects include stinging, burning, soreness, or itching in the area of treated skin during the first few days of treatment. Headache, acne, "hair bumps" (folliculitis), stomach upset, flu-like symptoms (e.g., fever, chills, runny nose, sore throat, muscle aches), or increased sensitivity of the skin to hot/cold/pain/touch may also occur.

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. Breast-feeding 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Protopic in Detail - Patient Information: Side Effects

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Protopic Overview - Patient Information: Side Effects

SIDE EFFECTS: Stinging, burning, soreness, or itching in the area of treated skin may occur during the first few days of treatment. Headache, acne, "hair bumps" (folliculitis), stomach upset, flu-like symptoms (e.g., fever, chills, runny nose, sore throat, muscle aches), or increased sensitivity of the skin to hot/cold/pain/touch may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: unusual tiredness, back/joint/muscle pain, appearance of any skin infections or sores (e.g., chicken pox, shingles, lip sores, tumors, warts).

Tell your doctor immediately if this rare but very serious side effect occurs: chest pain.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Protopic (Tacrolimus)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Protopic FDA Prescribing Information: Side Effects
(Adverse Reactions)

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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Protopic - User Reviews

Protopic User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Protopic sorted by most helpful. Patient Discussions FAQs

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.


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