(Drug Name) (Drug Form) (Drug Strength)
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Tacrolimus: Topical ointment (0.03%)

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What is this Medicine?

TACROLIMUS (ta KROE li mus) is used on the skin to treat eczema.

In-Depth Information
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Tacrolimus 0.03% Topical Ointment

NDC: 458020390
  • Prescription Required
  • Not a Controlled Drug
    (CSA Schedule)
  • FDA Approved




FDA approved for the following conditions:
Eczema, Atopic Dermatitis

Sometimes used for but not FDA approved for the following conditions:
Contact Dermatitis, Psoriasis, Lichen Sclerosus

Storage Information
Store at 77 degrees F; excursions permitted to 59-86 degrees F
Tacrolimus 0.03% Topical Ointment

Reported Side Effects for Tacrolimus 0.03% Topical Ointment

Post-transplant Lymphoproliferative Disorder (PTLD) Incidence:
<1.0%*
Severity: SEVERE
Onset: DELAYED
Inflamed Vocal Cords Incidence:
<1.0%*
Severity: MILD
Onset: DELAYED
Secondary Malignancy Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Stomach Pain Incidence:
<59.0%*
Severity: MILD
Onset: EARLY
Vaginal Infection Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Inflamed Eyes Incidence:
<1.0%*
Severity: MODERATE
Onset: EARLY
Bladder Infection Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
High Bilirubin Level Incidence:
0.2-15.0%*
Severity: MODERATE
Onset: DELAYED
Decreased Appetite Incidence:
0.2-34.0%*
Severity: MILD
Onset: DELAYED
Mouth Ulcers Incidence:
0.2-15.0%*
Severity: MODERATE
Onset: DELAYED
Dry Mouth Incidence:
0.2-1.0%*
Severity: MILD
Onset: EARLY
Mouth Sores Incidence:
0.2-1.0%*
Severity: MODERATE
Onset: DELAYED
Inflamed Stomach Incidence:
0.2-15.0%*
Severity: MODERATE
Onset: DELAYED
Constipation Incidence:
0.2-40.0%*
Severity: MODERATE
Onset: DELAYED
Metallic Taste Incidence:
0.2-1.0%*
Severity: MILD
Onset: EARLY
Inflamed Colon Incidence:
0.2-15.0%*
Severity: MODERATE
Onset: DELAYED
Upset Stomach Incidence:
1.0-28.0%*
Severity: MILD
Onset: EARLY
Upset Stomach Incidence:
1.0-46.0%*
Severity: MILD
Onset: EARLY
Fever Incidence:
1.0-48.0%*
Severity: MILD
Onset: EARLY
Enlarged Lymph Nodes Incidence:
1.0-10.0%*
Severity: MODERATE
Onset: DELAYED
Vomiting Incidence:
1.0-29.0%*
Severity: MILD
Onset: EARLY
Menstrual Cramps Incidence:
1.0-4.0%*
Severity: MILD
Onset: DELAYED
Conjunctivitis Incidence:
2.0-3.0%*
Severity: MODERATE
Onset: DELAYED
Rhinitis Incidence:
2.0-4.0%*
Severity: MILD
Onset: EARLY
Sinus Infection Incidence:
2.0-7.0%*
Severity: MILD
Onset: DELAYED
Loose Stools Incidence:
3.0-72.0%*
Severity: MILD
Onset: EARLY
Sore Throat Incidence:
3.0-12.0%*
Severity: MILD
Onset: DELAYED
*This is an approximate aggregated range of reported side effects from clinical studies performed on this drug. Your experience with this drug may be different.
Pregnancy & Lactation Information
FIRST Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

SECOND Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

THIRD Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

Lactation

Compatible - This drug is generally safe to take by nursing mothers.


Learning More About
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  • Find additional patient usage statistics
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Patient Experiences with Tacrolimus

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