Mediclarum
Medicine guide

Tacrolimus

1 mg/g · Ointment

  • Prescription only
  • Calcineurin Inhibitor Immunosuppressant
Active substance
Tacrolimus
Made by
Accord Healthcare Inc.

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2024-10-04

What it is

Calcineurin Inhibitor Immunosuppressant

Used for
  • Tacrolimus ointment, both 0.03% and 0.1% for
Serious warning

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…

All warnings ↓
Good to know
  • Prescription only
  • FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
93other products contain Tacrolimus — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

Tacrolimus ointment is not indicated for children younger than 2 years of age (see boxed WARNING , WARNINGS and PRECAUTIONS :

  • Tacrolimus 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.
  • Pediatric Use ).

From the official label · 2024-10-04 · DailyMed

How it works

From this product’s own US prescribing label.

The mechanism of action of tacrolimus in atopic dermatitis is not known.

While the following have been observed, the clinical significance of these observations in atopic dermatitis is not known.

Half-life15.9 h
Mostly cleared after≈ 3 daysfive half-lives — our arithmetic
How the body breaks it down

Tacrolimus is extensively metabolized by the mixed-function oxidase system, primarily the cytochrome P-450 system (CYP3A).

How it leaves the body

In man, less than 1% of the dose administered is excreted unchanged in urine.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2024-10-04

Serious warning

The strongest warning the FDA requires. It is printed in a box at the top of the label.

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

Quoted from the official label, section “Boxed Warning”.

Do not take it if

Tacrolimus ointment is contraindicated in patients with a history of hypersensitivity to tacrolimus or any other component of the ointment.

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

  • ADULT Tacrolimus ointment 0.03% and 0.1% Apply a thin layer of tacrolimus ointment to the affected skin twice daily.
  • The minimum amount should be rubbed in gently and completely to control signs and symptoms of atopic dermatitis.
  • Stop using when signs and symptoms of atopic dermatitis resolve.
  • If signs and symptoms (e.g. itch, rash, and redness) do not improve within 6 weeks, patients should be re-examined by their healthcare provider to confirm the diagnosis of atopic dermatitis.
  • Continuous long-term use of topical calcineurin inhibitors, including tacrolimus ointment should be avoided, and application should be limited to areas of involvement with atopic dermatitis.
  • The safety of tacrolimus ointment under occlusion, which may promote systemic exposure, has not been evaluated.
  • Tacrolimus ointment should not be used with occlusive dressings.
  • PEDIATRIC – FOR
  • CHILDREN 2 to 15 YEARS Tacrolimus ointment 0.03% Apply a thin layer of tacrolimus ointment, 0.03% to the affected skin twice daily.
  • The minimum amount should be rubbed in gently and completely to control signs and symptoms of atopic dermatitis.
  • Stop using when signs and symptoms of atopic dermatitis resolve.
  • If signs and symptoms (e.g. itch, rash, and redness) do not improve within 6 weeks, patients should be re-examined by their healthcare provider to confirm the diagnosis of atopic dermatitis.
  • Continuous long-term use of topical calcineurin inhibitors, including tacrolimus ointment should be avoided, and application should be limited to areas of involvement with atopic dermatitis.
  • The safety of tacrolimus ointment under occlusion, which may promote systemic exposure, has not been evaluated.
  • Tacrolimus ointment should not be used with occlusive dressings.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

  • WARNING 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 tacrolimus ointment.
  • Therefore:
  • Prolonged systemic use of calcineurin inhibitors for sustained immunosuppression in animal studies and transplant patients following systemic administration has been associated with an increased risk of infections, lymphomas, and skin malignancies.
  • These risks are associated with the intensity and duration of immunosuppression.
  • Based on the information above and the mechanism of action, there is a concern about potential risk with the use of topical calcineurin inhibitors, including tacrolimus ointment.
  • While a causal relationship has not been established, rare cases of skin malignancy and lymphoma have been reported in patients treated with topical calcineurin inhibitors, including tacrolimus ointment.
  • Therefore:
  • Tacrolimus ointment should not be used in immunocompromised
  • adults and children.
  • If signs and symptoms of atopic dermatitis do not improve within 6 weeks, patients should be re-examined by their healthcare provider and their diagnosis be confirmed (see PRECAUTIONS :
  • General).
  • The safety of tacrolimus ointment has not been established beyond one year of non-continuous use.
  • (See CLINICAL PHARMACOLOGY , boxed WARNING , INDICATIONS AND USAGE , and DOSAGE AND ADMINISTRATION ).
  • General The use of tacrolimus ointment should be avoided on pre-malignant and malignant skin conditions.
  • Some malignant skin conditions, such as cutaneous T-cell lymphoma (CTCL), may mimic atopic dermatitis.
  • The use of tacrolimus ointment is not recommended in patients having skin conditions with a skin barrier defect where there is the potential for increased systemic absorption of tacrolimus, including but not limited to, Netherton's syndrome, lamellar ichthyosis, generalized erythroderma or cutaneous Graft Versus Host Disease.
  • Oral application is also not recommended.
  • Post-marketing cases of increased tacrolimus blood level have been reported in these conditions.
  • The use of tacrolimus ointment may cause local symptoms such as skin burning (burning sensation, stinging, soreness) or pruritus.
  • Localized symptoms are most common during the first few days of tacrolimus ointment application and typically improve as the lesions of atopic dermatitis resolve.
  • With tacrolimus ointment 0.1%, 90% of the skin burning events had a duration between 2 minutes and 3 hours (median 15 minutes). 90% of the pruritus events had a duration between 3 minutes and 10 hours (median 20 minutes) (see ADVERSE REACTIONS ).
  • Bacterial and Viral Skin Infections Before commencing treatment with tacrolimus ointment, cutaneous bacterial or viral infections at treatment sites should be resolved.
  • Studies have not evaluated the safety and efficacy of tacrolimus ointment in the treatment of clinically infected atopic dermatitis.
  • While patients with atopic dermatitis are predisposed to superficial skin infections including eczema herpeticum (Kaposi’s varicelliform eruption), treatment with tacrolimus ointment may be independently associated with an increased risk of varicella zoster virus infection (chicken pox or shingles), herpes simplex virus infection, or eczema herpeticum.
  • Patients with Lymphadenopathy In clinical studies, 112/13494 (0.8%) cases of lymphadenopathy were reported and were usually related to infections (particularly of the skin) and noted to resolve upon appropriate antibiotic therapy.
  • Of these 112 cases, the majority had either a clear etiology or were known to resolve.
  • Transplant patients receiving immunosuppressive regimens (e.g., systemic tacrolimus) are at increased risk for developing lymphoma; therefore, patients who receive tacrolimus ointment and who develop lymphadenopathy should have the etiology of their lymphadenopathy investigated.
  • In the absence of a clear etiology for the lymphadenopathy, or in the presence of acute infectious mononucleosis, tacrolimus ointment should be discontinued.
  • Patients who develop lymphadenopathy should be monitored to ensure that the lymphadenopathy resolves.
  • Sun Exposure During the course of treatment, patients should minimize or
  • avoid natural or artificial sunlight exposure, even while tacrolimus ointment is not on the skin.
  • It is not known whether tacrolimus ointment interferes with skin response to ultraviolet damage.
  • Immunocompromised Patients The safety and efficacy of tacrolimus ointment in immunocompromised patients have not been studied.
  • Renal Insufficiency Rare post-marketing cases of acute renal failure have been reported in patients treated with tacrolimus ointment.
  • Systemic absorption is more likely to occur in patients with epidermal barrier defects especially when tacrolimus ointment is applied to large body surface areas.
  • Caution should also be exercised in patients predisposed to renal impairment.
  • Information for Patients (See Medication Guide ) Patients using tacrolimus ointment should receive and understand the information in the Medication Guide.
  • Use
  • Drug Interactions Formal topical drug interaction studies with tacrolimus ointment have not been conducted.
  • Carcinogenesis, Mutagenesis, Impairment of Fertility No evidence of genotoxicity was seen in bacterial ( Salmonella and E. coli ) or mammalian (Chinese hamster lung-derived cells) in vitro assays of mutagenicity, the in vitro CHO/HGPRT assay of mutagenicity, or in vivo clastogenicity assays performed in mice.
  • Tacrolimus did not cause unscheduled DNA synthesis in rodent hepatocytes.
  • Oral (feed) carcinogenicity studies have been carried out with systemically administered tacrolimus in male and female rats and mice.
  • In the 80-week mouse study and in the 104-week rat study no relationship of tumor incidence to tacrolimus dosage was found at daily doses up to 3 mg/kg [9X the Maximum Recommended Human Dose (MRHD) based on AUC comparisons] and 5 mg/kg (3X the MRHD based on AUC comparisons), respectively.
  • A 104-week dermal carcinogenicity study was performed in mice with tacrolimus ointment (0.03% to 3%), equivalent to tacrolimus doses of 1.1 to 118 mg/kg/day or 3.3 to 354 mg/m 2 /day.
  • In the study, the incidence of skin tumors was minimal and the topical application of tacrolimus was not associated with skin tumor formation under ambient room lighting.
  • However, a statistically significant elevation in the incidence of pleomorphic lymphoma in high dose male (25/50) and female animals (27/50) and in the incidence of undifferentiated lymphoma in high dose female animals (13/50) was noted in the mouse dermal carcinogenicity study.
  • Lymphomas were noted in the mouse dermal carcinogenicity study at a daily dose of 3.5 mg/kg (0.1% tacrolimus ointment) (26X MRHD based on AUC comparisons).
  • No drug-related tumors were noted in the mouse dermal carcinogenicity study at a daily dose of 1.1 mg/kg (0.03% tacrolimus ointment) (10X MRHD based on AUC comparisons).
  • In a 52-week photocarcinogenicity study, the median time to onset of skin tumor formation was decreased in hairless mice following chronic topical dosing with concurrent exposure to UV radiation (40 weeks of treatment followed by 12 weeks of observation) with tacrolimus ointment at ≥0.1% tacrolimus.
  • Reproductive toxicology studies were not performed with topical tacrolimus.
  • In studies of oral tacrolimus no impairment of fertility was seen in male and female rats.
  • Tacrolimus, given orally at 1.0 mg/kg (0.12X MRHD based on body surface area [BSA]) to male and female rats, prior to and during mating, as well as to dams during gestation and lactation, was associated with embryolethality and with adverse effects on female reproduction.
  • Effects on female reproductive function (parturition) and embryolethal effects were indicated by a higher rate of pre-implantation loss and increased numbers of undelivered and nonviable pups.
  • When given at 3.2 mg/kg (0.43X MRHD based on BSA), tacrolimus was associated with maternal and paternal toxicity as well as reproductive toxicity including marked adverse effects on estrus cycles, parturition, pup viability, and pup malformations.
  • Pregnancy Teratogenic Effects There are no adequate and well-controlled studies of topically administered tacrolimus in pregnant women.
  • Pediatric Use Tacrolimus ointment is not indicated for children less than 2 years of age.
  • Geriatric Use Four hundred and four (404) patients ≥ 65 years old received tacrolimus ointment in phase 3 studies.
  • General The use of tacrolimus ointment should be avoided on pre-malignant and malignant skin conditions.
  • Some malignant skin conditions, such as cutaneous T-cell lymphoma (CTCL), may mimic atopic dermatitis.
  • The use of tacrolimus ointment is not recommended in patients having skin conditions with a skin barrier defect where there is the potential for increased systemic absorption of tacrolimus, including but not limited to, Netherton's syndrome, lamellar ichthyosis, generalized erythroderma or cutaneous Graft Versus Host Disease.
  • Oral application is also not recommended.
  • Post-marketing cases of increased tacrolimus blood level have been reported in these conditions.
  • The use of tacrolimus ointment may cause local symptoms such as skin burning (burning sensation, stinging, soreness) or pruritus.
  • Localized symptoms are most common during the first few days of tacrolimus ointment application and typically improve as the lesions of atopic dermatitis resolve.
  • With tacrolimus ointment 0.1%, 90% of the skin burning events had a duration between 2 minutes and 3 hours (median 15 minutes). 90% of the pruritus events had a duration between 3 minutes and 10 hours (median 20 minutes) (see ADVERSE REACTIONS ).

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

  • Teratogenic Effects There are no adequate and well-controlled studies of topically administered tacrolimus in pregnant women.
  • The experience with tacrolimus ointment when used by pregnant women is too limited to permit assessment of the safety of its use during pregnancy.
  • Reproduction studies were carried out with systemically administered tacrolimus in rats and rabbits.
  • Adverse effects on the fetus were observed mainly at oral dose levels that were toxic to dams.
  • Tacrolimus at oral doses of 0.32 and 1.0 mg/kg (0.04X to 0.12X MRHD based on BSA) during organogenesis in rabbits was associated with maternal toxicity as well as an increase in incidence of abortions.
  • At the higher dose only, an increased incidence of malformations and developmental variations was also seen.
  • Tacrolimus, at oral doses of 3.2 mg/kg during organogenesis in rats, was associated with maternal toxicity and caused an increase in late resorptions, decreased numbers of live births, and decreased pup weight and viability.
  • Tacrolimus, given orally at 1.0 and 3.2 mg/kg (0.04X to 0.12X MRHD based on BSA) to pregnant rats after organogenesis and during lactation, was associated with reduced pup weights.
  • No reduction in male or female fertility was evident.
  • There are no adequate and well-controlled studies of systemically administered tacrolimus in pregnant women.
  • Tacrolimus is transferred across the placenta.
  • The use of systemically administered tacrolimus during pregnancy has been associated with neonatal hyperkalemia and renal dysfunction.
  • Tacrolimus ointment should be used during pregnancy only if the potential benefit to the mother justifies a potential risk to the fetus.
  • Nursing Mothers Although systemic absorption of tacrolimus following topical applications of tacrolimus ointment is minimal relative to systemic administration, it is known that tacrolimus is excreted in human milk.
  • Because of the potential for serious adverse reactions in nursing infants from tacrolimus, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
  • Although systemic absorption of tacrolimus following topical applications of tacrolimus ointment is minimal relative to systemic administration, it is known that tacrolimus is excreted in human milk.
  • Because of the potential for serious adverse reactions in nursing infants from tacrolimus, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

  • Formal topical drug interaction studies with tacrolimus ointment have not been conducted.
  • Based on its extent of absorption, interactions of tacrolimus ointment with systemically administered drugs are unlikely to occur but cannot be ruled out (see CLINICAL PHARMACOLOGY ).
  • 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 erythromycin, itraconazole, ketoconazole, fluconazole, calcium channel blockers and cimetidine.

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Tacrolimus ointment is not for oral use. Oral ingestion of tacrolimus ointment may lead to adverse effects associated with systemic administration of tacrolimus. If oral ingestion occurs, medical advice should be sought.

Quoted from the official label, section “Overdosage”.

Use in children

  • Tacrolimus ointment is not indicated for children less than 2 years of age.
  • Only the lower concentration, 0.03%, of tacrolimus ointment is recommended for use as a second-line therapy for short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised
  • children 2 to 15 years of age who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable.
  • The long-term safety and effects of tacrolimus ointment on the developing immune system are unknown (see boxed WARNING , WARNINGS and INDICATIONS AND USAGE ).
  • Four studies were conducted involving a total of about 4,400 patients 2 to 15 years of age:
  • one 12-week randomized vehicle-controlled study and three open-label safety studies of one to three years duration.
  • About 2,500 of these patients were 2 to 6 years of age.
  • The most common adverse events from these studies associated with tacrolimus ointment application in pediatric patients were skin burning and pruritus (see ADVERSE REACTIONS ).
  • In addition to skin burning and pruritus, the less common events (< 5%) of varicella zoster (mostly chicken pox), and vesiculobullous rash were more frequent in patients treated with tacrolimus ointment 0.03% compared to vehicle.
  • In the open-label safety studies, the incidence of adverse events, including infections, did not increase with increased duration of study drug exposure or amount of ointment used.
  • In about 4,400 pediatric patients treated with tacrolimus ointment, 24 (0.5%) were reported with eczema herpeticum.
  • Since the safety and efficacy of tacrolimus ointment have not been established in pediatric patients below 2 years of age, its use in this age group is not recommended.
  • In an open-label study, immune response to a 23-valent pneumococcal polysaccharide vaccine was assessed in 23
  • children 2 to 12 years old with moderate to severe atopic dermatitis treated with tacrolimus ointment 0.03%.
  • Protective antibody titers developed in all patients.
  • Similarly, in a seven-month, double-blind trial, the vaccination response to meningococcal serogroup C was equivalent in
  • children 2 to 11 years old with moderate to severe atopic dermatitis treated with tacrolimus ointment 0.03% (n=121), a hydrocortisone ointment regimen (n=111), or normal children (n=44).

Quoted from the official label, section “Pediatric Use”.

Use in older people

Four hundred and four (404) patients ≥ 65 years old received tacrolimus ointment in phase 3 studies. The adverse event profile for these patients was consistent with that for other adult patients.

Quoted from the official label, section “Geriatric Use”.

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 tacrolimus 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, tacrolimus ointment 0.03%, and tacrolimus 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 May be reasonably associated with the use of this drug product 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 Generally “warts”. 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 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. 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 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 tacrolimus 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 Neoplasms Lymphomas, basal cell carcinoma, squamous cell carcinoma, malignant melanoma Infections Bullous impetigo, osteomyelitis, septicemia Renal Acute renal failure in patients with or without Netherton’s syndrome, renal impairment Skin Rosacea, application site edema To report SUSPECTED ADVERSE REACTIONS, contact Accord Healthcare Inc. at 1-866-941-7875 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch OVERDOSAGE Tacrolimus ointment is not for oral use.
  • Oral ingestion of tacrolimus ointment may lead to adverse effects associated with systemic administration of tacrolimus.
  • If oral ingestion occurs, medical advice should be sought.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

  • (See Medication Guide ) Patients using tacrolimus ointment should receive and understand the information in the Medication Guide.
  • Please refer to the Medication Guide for providing instruction and information to the patient.
  • What is the most important information patients should know about tacrolimus ointment? The safety of using tacrolimus ointment for a long period of time is not known.
  • A very small number of people who have used tacrolimus ointment have had cancer (for example, skin or lymphoma).
  • However, a link with tacrolimus ointment has not been shown.
  • Because of this concern, instruct patients:
  • Do not use tacrolimus ointment continuously for a long time.
  • Use tacrolimus ointment only on areas of skin that have eczema.
  • Do not use tacrolimus ointment on a child under 2 years old.
  • Tacrolimus ointment comes in two strengths:
  • Only tacrolimus ointment 0.03% is for use on children aged 2 to 15 years.
  • Either tacrolimus ointment 0.03% or 0.1% can be used by
  • adults and children 16 years and older.
  • Advise patients to talk to their prescriber for more information.
  • How should tacrolimus ointment be used? Advise patients to:
  • Use tacrolimus ointment exactly as prescribed.
  • Use tacrolimus ointment only on areas of skin that have eczema.
  • Use tacrolimus ointment for short periods, and if needed, treatment may be repeated with breaks in between.
  • Stop tacrolimus ointment when the signs and symptoms of eczema, such as itching, rash, and redness go away, or as directed.
  • Follow their doctor’s advice
  • if symptoms of eczema return after treatment with tacrolimus ointment.
  • Call their doctor if: Their symptoms get worse with tacrolimus ointment.
  • They get an infection on their skin.
  • Their symptoms do not improve after 6 weeks of treatment.
  • Sometimes other skin diseases can look like eczema.
  • To apply tacrolimus ointment:
  • Advise patients:
  • Wash their hands before applying tacrolimus ointment.
  • Apply a thin layer of tacrolimus ointment twice daily to the areas of skin affected by eczema.
  • Use
  • the smallest amount of tacrolimus ointment needed to control the signs and symptoms of eczema.
  • If they are a caregiver applying tacrolimus ointment to a patient, or if they are a patient who is not treating their hands, wash their hands with soap and water after applying tacrolimus ointment.
  • This should remove any ointment left on the hands.
  • Do not bathe, shower, or swim right after applying tacrolimus ointment.
  • This could wash off the ointment.
  • Moisturizers can be used with tacrolimus ointment.
  • Make sure they check with their doctor first about the products that are right for them.
  • Because the skin of patients with eczema can be very dry, it is important to keep up good skin care practices.
  • If they use moisturizers, apply them after tacrolimus ointment.
  • What should patients
  • avoid while using tacrolimus ointment? Advise patients:
  • Do not use ultraviolet light therapy, sun lamps, or tanning beds during treatment with tacrolimus ointment.
  • Limit sun exposure during treatment with tacrolimus ointment even when the medicine is not on their skin.
  • If patients need to be outdoors after applying tacrolimus ointment, wear loose fitting clothing that protects the treated area from the sun.
  • Doctors should advise what other types of protection from the sun patients should use.
  • Do not cover the skin being treated with bandages, dressings or wraps.
  • Patients can wear normal clothing.
  • Avoid getting tacrolimus ointment in the eyes or mouth.
  • Do not swallow tacrolimus ointment.
  • Patients should call their doctor if they swallow tacrolimus ointment.

Quoted from the official label, section “Patient Counseling Information”.

What it looks like and how it is packed

  • Tacrolimus ointment 0.03% NDC 16729-421-10 30 gram laminate tube NDC 16729-421-12 60 gram laminate tube 16729-421-01 100 gram laminate tube Tacrolimus ointment 0.1% NDC 16729-422-10 30 gram laminate tube NDC 16729-422-12 60 gram laminate tube NDC 16729-422-01 100 gram laminate tube
  • Store at 25°C (77°F):
  • excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature.] Manufactured for:
  • Accord Healthcare, Inc., 8041 Arco Corporate Drive, Suite 200, Raleigh, NC 27617, USA.
  • Manufactured by:
  • Intas Pharmaceuticals Limited, Plot No.:457/458-Matoda/ Plot No.191/218P-Chacharwadi, Sarkhej-Bavla Highway, Taluka - Sanand, Matoda, Ahmedabad, Gujarat 382210, India. 10 2400 2 6031391 Issued July 2024

Quoted from the official label, section “How Supplied”.

What is in it

  • Tacrolimus ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis . It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3 S -[3 R *[ E (1 S *,3 S *,4 S *)],4 S *,5 R *,8 S *,9 E ,12 R *,14 R *,15 S *,16 R *,18 S *,19 S *,26a R *]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10, 12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1- c ][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone,monohydrate. It has the following structural formula:
  • Tacrolimus has an empirical formula of C 44 H 69 NO 12
  • H 2 O and a formula weight of 822.03. Each gram of tacrolimus ointment contains (w/w) either 0.03% or 0.1% of tacrolimus in a base of mineral oil, paraffin, propylene carbonate, white petrolatum and white wax. structure

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (7)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

Hide versions whose label lists:

Showing 7 of 7

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

European UnionNo exact match for this strength and form

Every strength and form (6)

Spain5 matching products

Every strength and form (54)

CanadaNo exact match for this strength and form

Every strength and form (27)

Details

Made byAccord Healthcare Inc.
Active substanceTacrolimus
Used inCancer treatments and immune-system medicines
Strength1 mg/g
FormOintment
RouteTopical
Packs1 TUBE in 1 CARTON / 100 g in 1 TUBE · 1 TUBE in 1 CARTON / 30 g in 1 TUBE
NDC16729-422

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

Report wrong or outdated information on this page

Other strengths and forms

89 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Show all forms · 6 forms

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Envarsus Xr1 mgPrescription onlyTablet, Extended Release Veloxis Pharmaceuticals, Inc · TacrolimusEnvarsus Xr4 mgPrescription onlyTablet, Extended Release Veloxis Pharmaceuticals, Inc · TacrolimusEnvarsus Xr.75 mgPrescription onlyTablet, Extended Release Veloxis Pharmaceuticals, Inc · TacrolimusPrograf.5 mgPrescription onlyCapsule, Gelatin Coated Astellas Pharma US, Inc. · TacrolimusPrograf1 mgPrescription onlyCapsule, Gelatin Coated Astellas Pharma US, Inc. · TacrolimusPrograf5 mgPrescription onlyCapsule, Gelatin Coated Astellas Pharma US, Inc. · Tacrolimus

See every product with Tacrolimus