Tacrolimus

Vitiligo, Pyoderma Gangrenosum, Kidney Transplantation + 12 more
Treatment
3 FDA approvals
20 Active Studies for Tacrolimus

What is Tacrolimus

TacrolimusThe Generic name of this drug
Treatment SummaryTacrolimus (also known as FK-506 or Fujimycin) is a drug used to weaken a patient’s immune system after organ transplant. It can also be used as a topical treatment for severe atopic dermatitis, severe uveitis after bone marrow transplants, and vitiligo. Tacrolimus was discovered in 1984 from the bacteria Streptomyces tsukubaensis found in a Japanese soil sample. It works by binding to a protein called immunophilin FKBP-12, which then inhibits certain processes within the immune system.
Prografis the brand name
image of different drug pills on a surface
Tacrolimus Overview & Background
Brand Name
Generic Name
First FDA Approval
How many FDA approvals?
Prograf
Tacrolimus
1994
138

Approved as Treatment by the FDA

Tacrolimus, also called Prograf, is approved by the FDA for 3 uses such as Kidney Transplantation and Kidney .
Kidney Transplantation
Kidney
Immunosuppressive Treatment

Effectiveness

How Tacrolimus Affects PatientsTacrolimus works by blocking a protein (FKBP-12) that helps send signals to T-lymphocytes, which are involved in the body's immune response. It is similar to cyclosporine, but has been shown to be more effective in reducing rejection rates. Tacrolimus is also used to treat eczema, and while it can reduce inflammation like steroids, it is not as strong. It is a great option for treating eczema on the face, as other topical steroids can thin the skin there. For other parts of the body, topical steroids are usually a better option.
How Tacrolimus works in the bodyThe exact way tacrolimus works on atopic dermatitis is uncertain. It is believed to affect lymphocyte activation by forming a complex of tacrolimus, FKBP-12, calcium, calmodulin, and calcineurin. This prevents the movement and activity of a nuclear factor thought to initiate gene expression for lymphokine production. Tacrolimus also stops the gene transcription for various interleukins and other molecules involved in early T-cell activation, as well as blocks the release of pre-formed mediators from mast cells and basophils. Finally, it decreases the presence of a receptor

When to interrupt dosage

The suggested dosage of Tacrolimus is reliant upon the identified condition, such as Vitiligo, Rejection; Transplant, Kidney and Pyoderma Gangrenosum. The magnitude of dosage is contingent upon the delivery approach (e.g. Capsule, gelatin coated - Oral or Topical) specified in the table below.
Condition
Dosage
Administration
Pyoderma Gangrenosum
0.5 mg, , 1.0 mg, 5.0 mg, 0.001 mg/mg, 0.0003 mg/mg, 4.0 mg, 0.75 mg, 3.0 mg, 0.2 mg, 0.03 %, 0.1 %, 5.0 mg/mL, 5.0 mg/mg, 0.00003 mg/mg, 0.003 mg/mg
, Oral, Capsule, Capsule - Oral, Topical, Ointment - Topical, Ointment, Capsule, coated, extended release, Capsule, coated, extended release - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, extended release, Tablet, extended release - Oral, Intravenous, Solution - Intravenous, Solution, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension, Granule, for suspension - Oral, Kit, Cream, Cream - Topical, Solution - Topical
Psoriasis
0.5 mg, , 1.0 mg, 5.0 mg, 0.001 mg/mg, 0.0003 mg/mg, 4.0 mg, 0.75 mg, 3.0 mg, 0.2 mg, 0.03 %, 0.1 %, 5.0 mg/mL, 5.0 mg/mg, 0.00003 mg/mg, 0.003 mg/mg
, Oral, Capsule, Capsule - Oral, Topical, Ointment - Topical, Ointment, Capsule, coated, extended release, Capsule, coated, extended release - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, extended release, Tablet, extended release - Oral, Intravenous, Solution - Intravenous, Solution, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension, Granule, for suspension - Oral, Kit, Cream, Cream - Topical, Solution - Topical
Vitiligo
0.5 mg, , 1.0 mg, 5.0 mg, 0.001 mg/mg, 0.0003 mg/mg, 4.0 mg, 0.75 mg, 3.0 mg, 0.2 mg, 0.03 %, 0.1 %, 5.0 mg/mL, 5.0 mg/mg, 0.00003 mg/mg, 0.003 mg/mg
, Oral, Capsule, Capsule - Oral, Topical, Ointment - Topical, Ointment, Capsule, coated, extended release, Capsule, coated, extended release - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, extended release, Tablet, extended release - Oral, Intravenous, Solution - Intravenous, Solution, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension, Granule, for suspension - Oral, Kit, Cream, Cream - Topical, Solution - Topical
Immunocompromised
0.5 mg, , 1.0 mg, 5.0 mg, 0.001 mg/mg, 0.0003 mg/mg, 4.0 mg, 0.75 mg, 3.0 mg, 0.2 mg, 0.03 %, 0.1 %, 5.0 mg/mL, 5.0 mg/mg, 0.00003 mg/mg, 0.003 mg/mg
, Oral, Capsule, Capsule - Oral, Topical, Ointment - Topical, Ointment, Capsule, coated, extended release, Capsule, coated, extended release - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, extended release, Tablet, extended release - Oral, Intravenous, Solution - Intravenous, Solution, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension, Granule, for suspension - Oral, Kit, Cream, Cream - Topical, Solution - Topical
Liver
0.5 mg, , 1.0 mg, 5.0 mg, 0.001 mg/mg, 0.0003 mg/mg, 4.0 mg, 0.75 mg, 3.0 mg, 0.2 mg, 0.03 %, 0.1 %, 5.0 mg/mL, 5.0 mg/mg, 0.00003 mg/mg, 0.003 mg/mg
, Oral, Capsule, Capsule - Oral, Topical, Ointment - Topical, Ointment, Capsule, coated, extended release, Capsule, coated, extended release - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, extended release, Tablet, extended release - Oral, Intravenous, Solution - Intravenous, Solution, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension, Granule, for suspension - Oral, Kit, Cream, Cream - Topical, Solution - Topical
Dermatitis, Atopic
0.5 mg, , 1.0 mg, 5.0 mg, 0.001 mg/mg, 0.0003 mg/mg, 4.0 mg, 0.75 mg, 3.0 mg, 0.2 mg, 0.03 %, 0.1 %, 5.0 mg/mL, 5.0 mg/mg, 0.00003 mg/mg, 0.003 mg/mg
, Oral, Capsule, Capsule - Oral, Topical, Ointment - Topical, Ointment, Capsule, coated, extended release, Capsule, coated, extended release - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, extended release, Tablet, extended release - Oral, Intravenous, Solution - Intravenous, Solution, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension, Granule, for suspension - Oral, Kit, Cream, Cream - Topical, Solution - Topical
Kidney
0.5 mg, , 1.0 mg, 5.0 mg, 0.001 mg/mg, 0.0003 mg/mg, 4.0 mg, 0.75 mg, 3.0 mg, 0.2 mg, 0.03 %, 0.1 %, 5.0 mg/mL, 5.0 mg/mg, 0.00003 mg/mg, 0.003 mg/mg
, Oral, Capsule, Capsule - Oral, Topical, Ointment - Topical, Ointment, Capsule, coated, extended release, Capsule, coated, extended release - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, extended release, Tablet, extended release - Oral, Intravenous, Solution - Intravenous, Solution, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension, Granule, for suspension - Oral, Kit, Cream, Cream - Topical, Solution - Topical
Rheumatoid Arthritis
0.5 mg, , 1.0 mg, 5.0 mg, 0.001 mg/mg, 0.0003 mg/mg, 4.0 mg, 0.75 mg, 3.0 mg, 0.2 mg, 0.03 %, 0.1 %, 5.0 mg/mL, 5.0 mg/mg, 0.00003 mg/mg, 0.003 mg/mg
, Oral, Capsule, Capsule - Oral, Topical, Ointment - Topical, Ointment, Capsule, coated, extended release, Capsule, coated, extended release - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, extended release, Tablet, extended release - Oral, Intravenous, Solution - Intravenous, Solution, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension, Granule, for suspension - Oral, Kit, Cream, Cream - Topical, Solution - Topical
Chronic Graft Versus Host Disease
0.5 mg, , 1.0 mg, 5.0 mg, 0.001 mg/mg, 0.0003 mg/mg, 4.0 mg, 0.75 mg, 3.0 mg, 0.2 mg, 0.03 %, 0.1 %, 5.0 mg/mL, 5.0 mg/mg, 0.00003 mg/mg, 0.003 mg/mg
, Oral, Capsule, Capsule - Oral, Topical, Ointment - Topical, Ointment, Capsule, coated, extended release, Capsule, coated, extended release - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, extended release, Tablet, extended release - Oral, Intravenous, Solution - Intravenous, Solution, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension, Granule, for suspension - Oral, Kit, Cream, Cream - Topical, Solution - Topical
Oral Lichen Planus
0.5 mg, , 1.0 mg, 5.0 mg, 0.001 mg/mg, 0.0003 mg/mg, 4.0 mg, 0.75 mg, 3.0 mg, 0.2 mg, 0.03 %, 0.1 %, 5.0 mg/mL, 5.0 mg/mg, 0.00003 mg/mg, 0.003 mg/mg
, Oral, Capsule, Capsule - Oral, Topical, Ointment - Topical, Ointment, Capsule, coated, extended release, Capsule, coated, extended release - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, extended release, Tablet, extended release - Oral, Intravenous, Solution - Intravenous, Solution, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension, Granule, for suspension - Oral, Kit, Cream, Cream - Topical, Solution - Topical
Immunosuppressive Treatment
0.5 mg, , 1.0 mg, 5.0 mg, 0.001 mg/mg, 0.0003 mg/mg, 4.0 mg, 0.75 mg, 3.0 mg, 0.2 mg, 0.03 %, 0.1 %, 5.0 mg/mL, 5.0 mg/mg, 0.00003 mg/mg, 0.003 mg/mg
, Oral, Capsule, Capsule - Oral, Topical, Ointment - Topical, Ointment, Capsule, coated, extended release, Capsule, coated, extended release - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, extended release, Tablet, extended release - Oral, Intravenous, Solution - Intravenous, Solution, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension, Granule, for suspension - Oral, Kit, Cream, Cream - Topical, Solution - Topical
Kidney Transplantation
0.5 mg, , 1.0 mg, 5.0 mg, 0.001 mg/mg, 0.0003 mg/mg, 4.0 mg, 0.75 mg, 3.0 mg, 0.2 mg, 0.03 %, 0.1 %, 5.0 mg/mL, 5.0 mg/mg, 0.00003 mg/mg, 0.003 mg/mg
, Oral, Capsule, Capsule - Oral, Topical, Ointment - Topical, Ointment, Capsule, coated, extended release, Capsule, coated, extended release - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, extended release, Tablet, extended release - Oral, Intravenous, Solution - Intravenous, Solution, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension, Granule, for suspension - Oral, Kit, Cream, Cream - Topical, Solution - Topical
Prophylaxis against heart transplant rejection
0.5 mg, , 1.0 mg, 5.0 mg, 0.001 mg/mg, 0.0003 mg/mg, 4.0 mg, 0.75 mg, 3.0 mg, 0.2 mg, 0.03 %, 0.1 %, 5.0 mg/mL, 5.0 mg/mg, 0.00003 mg/mg, 0.003 mg/mg
, Oral, Capsule, Capsule - Oral, Topical, Ointment - Topical, Ointment, Capsule, coated, extended release, Capsule, coated, extended release - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, extended release, Tablet, extended release - Oral, Intravenous, Solution - Intravenous, Solution, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension, Granule, for suspension - Oral, Kit, Cream, Cream - Topical, Solution - Topical
Dermatitis, Atopic
0.5 mg, , 1.0 mg, 5.0 mg, 0.001 mg/mg, 0.0003 mg/mg, 4.0 mg, 0.75 mg, 3.0 mg, 0.2 mg, 0.03 %, 0.1 %, 5.0 mg/mL, 5.0 mg/mg, 0.00003 mg/mg, 0.003 mg/mg
, Oral, Capsule, Capsule - Oral, Topical, Ointment - Topical, Ointment, Capsule, coated, extended release, Capsule, coated, extended release - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, extended release, Tablet, extended release - Oral, Intravenous, Solution - Intravenous, Solution, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension, Granule, for suspension - Oral, Kit, Cream, Cream - Topical, Solution - Topical
Lung
0.5 mg, , 1.0 mg, 5.0 mg, 0.001 mg/mg, 0.0003 mg/mg, 4.0 mg, 0.75 mg, 3.0 mg, 0.2 mg, 0.03 %, 0.1 %, 5.0 mg/mL, 5.0 mg/mg, 0.00003 mg/mg, 0.003 mg/mg
, Oral, Capsule, Capsule - Oral, Topical, Ointment - Topical, Ointment, Capsule, coated, extended release, Capsule, coated, extended release - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, extended release, Tablet, extended release - Oral, Intravenous, Solution - Intravenous, Solution, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension, Granule, for suspension - Oral, Kit, Cream, Cream - Topical, Solution - Topical

Warnings

Tacrolimus Contraindications
Condition
Risk Level
Notes
Severe Hypersensitivity Reactions
Do Not Combine
Tacrolimus may interact with Pulse Frequency
There are 20 known major drug interactions with Tacrolimus.
Common Tacrolimus Drug Interactions
Drug Name
Risk Level
Description
Abemaciclib
Major
The serum concentration of Abemaciclib can be increased when it is combined with Tacrolimus.
Alectinib
Major
The metabolism of Alectinib can be decreased when combined with Tacrolimus.
Aminophylline
Major
The metabolism of Aminophylline can be decreased when combined with Tacrolimus.
Axitinib
Major
The serum concentration of Axitinib can be increased when it is combined with Tacrolimus.
Bacillus calmette-guerin substrain russian BCG-I live antigen
Major
The therapeutic efficacy of Bacillus calmette-guerin substrain russian BCG-I live antigen can be decreased when used in combination with Tacrolimus.
Tacrolimus Toxicity & Overdose RiskThe side effects of overdose on this medication can be serious, such as blurred vision, kidney and liver damage, seizures, uncontrollable shaking, high blood pressure, low levels of magnesium, diabetes, high levels of potassium, itching, trouble sleeping, and confusion. The lowest toxic dose in rats is between 134-194 mg/kg.
image of a doctor in a lab doing drug, clinical research

Tacrolimus Novel Uses: Which Conditions Have a Clinical Trial Featuring Tacrolimus?

147 active clinical trials are analyzing the potential of Tacrolimus to ameliorate Oral Lichen Planus, Pyoderma Gangrenosum and refractory Rheumatoid Arthritis.
Condition
Clinical Trials
Trial Phases
Rheumatoid Arthritis
61 Actively Recruiting
Not Applicable, Phase 4, Phase 3, Phase 2, Phase 1
Vitiligo
18 Actively Recruiting
Phase 2, Phase 3, Not Applicable
Prophylaxis against heart transplant rejection
0 Actively Recruiting
Lung
0 Actively Recruiting
Pyoderma Gangrenosum
4 Actively Recruiting
Phase 2, Early Phase 1, Phase 3
Psoriasis
0 Actively Recruiting
Chronic Graft Versus Host Disease
29 Actively Recruiting
Not Applicable, Phase 2, Phase 4, Phase 1, Phase 3, Early Phase 1
Oral Lichen Planus
1 Actively Recruiting
Phase 2
Dermatitis, Atopic
0 Actively Recruiting
Kidney Transplantation
0 Actively Recruiting
Liver
0 Actively Recruiting
Immunosuppressive Treatment
0 Actively Recruiting
Immunocompromised
4 Actively Recruiting
Phase 3, Not Applicable, Phase 1
Dermatitis, Atopic
0 Actively Recruiting
Kidney
0 Actively Recruiting

Tacrolimus Reviews: What are patients saying about Tacrolimus?

5Patient Review
1/2/2012
Tacrolimus for Body's Rejection of a Transplanted Organ
I've had zero issues.
5Patient Review
10/13/2007
Tacrolimus for Prevention of Cardiac Transplant Rejection
5Patient Review
12/17/2008
Tacrolimus for Prevent Kidney Transplant Rejection
I had never experienced tremor before, but after starting this medication I quickly felt much better.
5Patient Review
1/2/2011
Tacrolimus for Prevention of Liver Transplant Rejection
This drug has been a life-saver for me. I have nephrotic syndrome, and before taking this pill, I was carrying around a lot of extra fluid in my stomach and other parts of my body. After taking this pill for a few months, I went from 160 pounds back down to my normal weight of 115 pounds. I didn't experience any side effects like I did when my doctor tried Cyclosporine. This drug turned my labs back to normal and made my weekly kidney appointments go from 4-5 times per month down to just once every few months. It's an amazing drug!
5Patient Review
7/31/2017
Tacrolimus for Prevention of Liver Transplant Rejection
I'm five months out from my transplant and I feel great! Thank you so much to my donor.
5Patient Review
4/29/2021
Tacrolimus for Prevention of Liver Transplant Rejection
I've been on this medication for 12 years. I had one liver rejection issue in the beginning, but it was quickly resolved by adjusting my dosage. I'm currently taking 1 mg in the morning and 2 mg at night.
4.7Patient Review
8/16/2008
Tacrolimus for Prevent Kidney Transplant Rejection
After my transplant, I've only experienced one or two rejections. This is due in large part to the Prograf medication I began taking shortly after the surgery.
4.3Patient Review
10/5/2019
Tacrolimus for Prevent of Transplant Rejection
I've had my liver transplants for 25 years and have been on cyclosporine, then tacrolimus. Recently, it's stopped an episode of acute rejection but I've experienced several side effects, including low platelets, headaches, ringing in the ears, difficulty swallowing, heart palpitations and tiredness. Has anyone else been having muscle weakness?
4Patient Review
10/25/2007
Tacrolimus for Prevention of Lung Transplant Rejection
4Patient Review
11/8/2010
Tacrolimus for Prevent of Transplant Rejection
I was originally on a lower dosage of this medication, but it actually ended up raising my IGG levels.
4Patient Review
3/23/2010
Tacrolimus for Prevent Kidney Transplant Rejection
Tacrolimus has been incredibly effective for me since my kidney/pancreas transplant. I've never had any rejection and it's honestly the best drug I'm on right now.
4Patient Review
10/3/2011
Tacrolimus for Prevention of Liver Transplant Rejection
I haven't had any major issues while using tacrolimus. My only complaint is that it caused a slight elevation in creatin levels in my kidneys.
3.7Patient Review
11/14/2013
Tacrolimus for Prevent of Transplant Rejection
One of the more distressing side effects is hair loss. Please be upfront about this potentiality when taking this medication, as it was not initially made clear to me.
3.7Patient Review
11/4/2019
Tacrolimus for Prevent Kidney Transplant Rejection
While this treatment has saved my kidney, the number of awful side effects have really impacted my quality of life.
3Patient Review
3/15/2010
Tacrolimus for Osteoporosis
After 13 hours of not taking prograf, my FK level is 14.6. Is this normal?
2.3Patient Review
1/24/2008
Tacrolimus for Prevent Kidney Transplant Rejection
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about tacrolimus

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is tacrolimus is a steroid?

"Tacrolimus is a prescription non-steroidal medication that is applied to the skin short-term to treat eczema, also known as atopic dermatitis."

Answered by AI

What drug class is tacrolimus?

"Tacrolimus is an immunosuppressant, a class of medication that works by decreasing the activity of the immune system to prevent it from attacking the transplanted organ."

Answered by AI

What does tacrolimus do to skin?

"This drug reduces eczema by weakening the skin's immune system, which decreases the allergic reaction. Tacrolimus is a type of drug called a topical calcineurin inhibitor (TCI)."

Answered by AI

What is tacrolimus is used for?

"Tacrolimus topical is used on the skin to treat moderate to severe atopic dermatitis. Atopic dermatitis is a skin condition where there is itching, redness, and inflammation, much like an allergic reaction."

Answered by AI

Clinical Trials for Tacrolimus

Have you considered Tacrolimus clinical trials? We made a collection of clinical trials featuring Tacrolimus, we think they might fit your search criteria.
Have you considered Tacrolimus clinical trials? We made a collection of clinical trials featuring Tacrolimus, we think they might fit your search criteria.
Have you considered Tacrolimus clinical trials? We made a collection of clinical trials featuring Tacrolimus, we think they might fit your search criteria.