Azathioprine

Lupus Nephritis, Pericarditis, Uveitis + 5 more

Treatment

3 FDA approvals

20 Active Studies for Azathioprine

What is Azathioprine

Azathioprine

The Generic name of this drug

Treatment Summary

Azathioprine is a medication used to treat inflammatory conditions like rheumatoid arthritis and to help prevent organ rejection after a transplant surgery. It was originally developed in 1956 and approved by the FDA in 1968. Azathioprine is a derivative of 6-mercaptopurine, meaning it is related to, but does not contain, the same active ingredient.

Imuran

is the brand name

image of different drug pills on a surface

Azathioprine Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Imuran

Azathioprine

1968

50

Approved as Treatment by the FDA

Azathioprine, otherwise called Imuran, is approved by the FDA for 3 uses like Kidney Transplant Rejection and Rheumatoid Arthritis .

Kidney Transplant Rejection

Rheumatoid Arthritis

Kidney Transplantation

Effectiveness

How Azathioprine Affects Patients

Azathioprine is a daily medication that helps to suppress the immune system. It works by affecting the cells that cause inflammation, and can also reduce the risk of cancer of the skin or lymph nodes. However, it is important to be aware that it can have side effects, so patients should discuss this with their doctor.

How Azathioprine works in the body

Azathioprine's exact effects aren't known, but it seems to limit the production of molecules called purines. It also blocks B and T cells from working properly. Azathioprine's metabolite, 6-thioguanine triphosphate, stops T cells from activating and causes them to die. This seems to be an effect of the molecule's action on a protein called rac1, which in turn affects other proteins like mitogen-activated protein kinase and NF-kappaB.

When to interrupt dosage

The suggested dosage of Azathioprine is subject to the determined condition, such as Atopic Dermatitis, Kidney Transplantation and Crohn's Disease. The measure can be seen in the table below, contingent upon the method of delivery (e.g. Tablet, film coated - Oral or Injection, powder, lyophilized, for solution - Intravenous).

Condition

Dosage

Administration

Lupus Nephritis

50.0 mg, , 75.0 mg, 100.0 mg, 10.0 mg/mL, 25.0 mg, 100.0 mg/mL

, Tablet, Tablet - Oral, Oral, Powder, for solution, Intravenous, Powder, for solution - Intravenous, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous, Tablet, film coated, Tablet, film coated - Oral, Suspension - Oral, Suspension

Pericarditis

50.0 mg, , 75.0 mg, 100.0 mg, 10.0 mg/mL, 25.0 mg, 100.0 mg/mL

, Tablet, Tablet - Oral, Oral, Powder, for solution, Intravenous, Powder, for solution - Intravenous, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous, Tablet, film coated, Tablet, film coated - Oral, Suspension - Oral, Suspension

Uveitis

50.0 mg, , 75.0 mg, 100.0 mg, 10.0 mg/mL, 25.0 mg, 100.0 mg/mL

, Tablet, Tablet - Oral, Oral, Powder, for solution, Intravenous, Powder, for solution - Intravenous, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous, Tablet, film coated, Tablet, film coated - Oral, Suspension - Oral, Suspension

Kidney Transplantation

50.0 mg, , 75.0 mg, 100.0 mg, 10.0 mg/mL, 25.0 mg, 100.0 mg/mL

, Tablet, Tablet - Oral, Oral, Powder, for solution, Intravenous, Powder, for solution - Intravenous, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous, Tablet, film coated, Tablet, film coated - Oral, Suspension - Oral, Suspension

Multiple Sclerosis

50.0 mg, , 75.0 mg, 100.0 mg, 10.0 mg/mL, 25.0 mg, 100.0 mg/mL

, Tablet, Tablet - Oral, Oral, Powder, for solution, Intravenous, Powder, for solution - Intravenous, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous, Tablet, film coated, Tablet, film coated - Oral, Suspension - Oral, Suspension

Rheumatoid Arthritis

50.0 mg, , 75.0 mg, 100.0 mg, 10.0 mg/mL, 25.0 mg, 100.0 mg/mL

, Tablet, Tablet - Oral, Oral, Powder, for solution, Intravenous, Powder, for solution - Intravenous, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous, Tablet, film coated, Tablet, film coated - Oral, Suspension - Oral, Suspension

Crohn's Disease

50.0 mg, , 75.0 mg, 100.0 mg, 10.0 mg/mL, 25.0 mg, 100.0 mg/mL

, Tablet, Tablet - Oral, Oral, Powder, for solution, Intravenous, Powder, for solution - Intravenous, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous, Tablet, film coated, Tablet, film coated - Oral, Suspension - Oral, Suspension

Psoriasis

50.0 mg, , 75.0 mg, 100.0 mg, 10.0 mg/mL, 25.0 mg, 100.0 mg/mL

, Tablet, Tablet - Oral, Oral, Powder, for solution, Intravenous, Powder, for solution - Intravenous, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous, Tablet, film coated, Tablet, film coated - Oral, Suspension - Oral, Suspension

Warnings

Azathioprine Contraindications

Condition

Risk Level

Notes

Severe Hypersensitivity Reactions

Do Not Combine

Azathioprine may interact with Pulse Frequency

Alkylating Agents

Do Not Combine

There are 20 known major drug interactions with Azathioprine.

Common Azathioprine Drug Interactions

Drug Name

Risk Level

Description

2-Methoxyethanol

Major

The risk or severity of adverse effects can be increased when Azathioprine is combined with 2-Methoxyethanol.

9-(N-methyl-L-isoleucine)-cyclosporin A

Major

The risk or severity of adverse effects can be increased when Azathioprine is combined with 9-(N-methyl-L-isoleucine)-cyclosporin A.

Abetimus

Major

The risk or severity of adverse effects can be increased when Azathioprine is combined with Abetimus.

Acteoside

Major

The risk or severity of adverse effects can be increased when Azathioprine is combined with Acteoside.

Aldosterone

Major

The risk or severity of adverse effects can be increased when Azathioprine is combined with Aldosterone.

Azathioprine Toxicity & Overdose Risk

The lowest toxic dose of the drug in mice has been found to be 2500mg/kg and 400mg/kg in rats. Those who overdose may experience decreased bone marrow production, bleeding, and infection, which can potentially be fatal. Treatment includes managing symptoms and hemodialysis, which can remove 45% of the dose from the bloodstream.

image of a doctor in a lab doing drug, clinical research

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

430 active clinical trials are currently underway to assess the potential of Azathioprine in the management of Rejection; Transplant, Kidney, Uveitis and Crohn's Disease.

Condition

Clinical Trials

Trial Phases

Crohn's Disease

54 Actively Recruiting

Phase 1, Phase 2, Not Applicable, Phase 3, Phase 4, Early Phase 1

Rheumatoid Arthritis

55 Actively Recruiting

Not Applicable, Phase 4, Phase 3, Phase 2, Phase 1

Lupus Nephritis

24 Actively Recruiting

Phase 3, Phase 2, Phase 1, Phase 4

Pericarditis

1 Actively Recruiting

Phase 2, Phase 3

Kidney Transplantation

0 Actively Recruiting

Uveitis

3 Actively Recruiting

Not Applicable, Phase 3

Multiple Sclerosis

127 Actively Recruiting

Phase 3, Not Applicable, Phase 4, Phase 2, Phase 1, Early Phase 1

Psoriasis

0 Actively Recruiting

Azathioprine Reviews: What are patients saying about Azathioprine?

5

Patient Review

2/2/2016

Azathioprine for Liver Inflammation caused by Body's Own Immune Response

I have autoimmune hepatitis and primary biliary cirrhosis of the liver, and this treatment has done wonders for me. My doctor increased my Ursodial dosage, and now my ALK PH levels are starting to drop as well.

4.7

Patient Review

12/23/2019

Azathioprine for Crohn's Disease

I've had Crohn's for a long time, and this treatment has really helped me stay in remission. I'm grateful that it exists, but my doctor wants me to switch to a different medication due to potential risks.

4.7

Patient Review

7/21/2016

Azathioprine for Ulcerated Colon

I was diagnosed with UC in December 2015 and then put on infliximab. I've been doing very well for the past six months, only experiencing some joint pain that is subsiding now. It's important to note that it takes 2-3 months for this drug to take effect.

4

Patient Review

6/12/2017

Azathioprine for Liver Inflammation caused by Body's Own Immune Response

I've been taking azathioprine for my autoimmune hepatitis for a year and a half now. The side effects were tough at first, but they've lessened with time. My doctor also prescribed me omeprazole for the nausea, which has helped immensely. I'm also being treated with plaquinel for my lupus and rheumatoid arthritis, and I'm hoping to feel normal soon.

3.7

Patient Review

4/29/2015

Azathioprine for Inflammation of Skin and Muscles All Over the Body

I did gain some weight while taking this medication, but it didn't make me lose my hair, so that's a plus.

3

Patient Review

2/8/2017

Azathioprine for Rheumatoid Arthritis

I'm finding that Aza is making me really tired and depressed. Has anyone else experienced this?

3

Patient Review

7/29/2020

Azathioprine for Rheumatoid Arthritis

So far, so good. I'm hopeful that this treatment will be effective in the long run.

2.7

Patient Review

1/15/2015

Azathioprine for Rheumatoid Arthritis

I'm experiencing numbness in my hands and an upset stomach. I think it might be time to stop this medication.

2.7

Patient Review

9/21/2015

Azathioprine for Liver Inflammation caused by Body's Own Immune Response

Azathioprine has been terrible for myAutoimmune Hepatitis. I've lost a lot of hair, and I'm constantly exhausted with joint and stomach pain. It's also made it hard to think clearly. My doctor doesn't seem to care about any of these side effects.

2.3

Patient Review

6/17/2016

Azathioprine for Ulcerated Colon

I started taking these tablets a few days ago and almost immediately thereafter, I developed an electric shock sensation on the side of my head. It's been getting worse since then and is now painful to the touch. I hope this stops soon.

2

Patient Review

6/3/2021

Azathioprine for Crohn's Disease

Azathioprine was an absolute nightmare for me. I had to stop taking it after just six months because the side effects were so severe. I would absolutely not recommend this medication to anyone.

2

Patient Review

5/8/2015

Azathioprine for Rheumatoid Arthritis

I found this medication made me excessively drowsy to the point where it was difficult to function. I discontinued use after three months.

1.7

Patient Review

9/30/2015

Azathioprine for Myasthenia Gravis

Azathioprine was supposed to help me reduce my daily intake of prednisone, but it's just been awful. I constantly feel sick, like I have a cold, and my stomach is in knots all the time. The last few times I've vomited there's even been blood in it. This prescription does nothing for my muscles, so it seems like prednisone is the only way.

1

Patient Review

8/9/2017

Azathioprine for Systemic Lupus Erythematosus

I developed a cyst after just three weeks of using this medication. It was incredibly painful and my doctor had to remove it surgically. He said it was an allergic reaction to the medication, so I stopped taking it immediately. I'm doing much better now!
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about azathioprine

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

What is the drug azathioprine used for?

"Can you take azathioprine with other medications?

Azathioprine is used with other medications to prevent transplant rejection (attack of the transplanted organ by the immune system) in people who received kidney transplants."

Answered by AI

Is azathioprine a steroid?

"Azathioprine is not a steroid, and it is thought to be safer to take in the long term than steroids."

Answered by AI

What are the side effects of taking azathioprine?

"The following are potential side effects of the medication: increased stomach irritation, abdominal pain, nausea and vomiting, changes in hair color and texture (along with hair loss), loss of appetite, blood in the urine or stool, unusual bruising, fatigue, development of mouth sores and ulcers."

Answered by AI

Is azathioprine like chemo?

"There are a few chemotherapy drugs that are used to treat rheumatic diseases. The three that are most widely used are Methotrexate, Azathioprine, and Cyclophosphamide. Methotrexate is the chemotherapy drug that is most often used to treat rheumatic diseases."

Answered by AI

Clinical Trials for Azathioprine

Image of University of Illinois at Chicago in Chicago, United States.

Functional Balance Intervention for Multiple Sclerosis

40 - 90
All Sexes
Chicago, IL

The study involves a two-arm, Phase 1, randomized controlled clinical trial designed to establish the feasibility and effects of a Functional Balance Intervention (FBI) on physical and cognitive function, as well as measures of daily living among persons with multiple sclerosis (PwMS). Combined Specific Aims: Aim 1: Examine the effect of the FBI (Intervention Group) on physical function in PwMS compared to a stretching program (Control Group). Hypothesis 1: After four months of training, the FBI group will show significantly greater improvements in physical function compared to the stretching group. Aim 2: Examine the effect of the multicomponent FBI on cognitive function in PwMS compared to the stretching program. Hypothesis 2: After four months of training, the FBI group will show significantly greater improvements in cognitive function compared to the stretching group. Aim 3: Examine the effects of the multicomponent FBI compared to the Control Group among PwMS on measures of daily living (dual-task performance, balance confidence, community mobility, and quality of life). Hypothesis 3: After four months of training, the FBI group will show significantly greater improvements in measures of daily living compared to the stretching group. All assessment sessions will be conducted virtually via Zoom. All measures collected during the initial screening, pre-training assessment, training progression, and mid- and post-training assessment sessions will be administered either via Zoom with a Helper Buddy present or through survey links sent to participants via the UIC REDCap system. The training sessions will be performed independently by the participants in the presence of a Helper Buddy. The investigators will recruit 75 people with multiple sclerosis (PwMS) for this study. Eligible participants will be randomized to either the FBI (Intervention) or stretching (Control) group, followed by an onboarding session with a designated Helper Buddy. Training will occur twice weekly for four months. Based on the anticipated attrition rate, the investigators aim for 40 PwMS to complete the post-training assessments and finish the study.

Recruiting
Has No Placebo

University of Illinois at Chicago

Image of The University of British Columbia in Vancouver, Canada.

Nutritional Therapy + Anti-TNFα for Crohn's Disease

9 - 17
All Sexes
Vancouver, Canada

Children with Crohn's disease (CD), a type of Inflammatory Bowel Disease (IBD), often face serious health challenges, including poor growth, frequent hospital stays, and long-term medication use. Although biologic drugs like infliximab, an anti-TNFα (Tumor necrosis factor α) medication, have improved treatment, they don't work for everyone: many children still experience symptoms or disease flare-ups. Nutritional therapies, especially the Crohn's Disease Exclusion Diet (CDED), may help improve treatment outcomes. This study will assess whether starting CDED at the same time as infliximab leads to better responses to treatment. The goal of this study is to improve how well children respond to therapy, reduce drug exposure, and support better long-term health.

Waitlist Available
Has No Placebo

The University of British Columbia

Kevan Jacobson, MBBCh, FRCP, FRCPC, AGAF, CAGF

Image of MUHC - Montreal General Hospital in Montreal, Canada.

Ustekinumab for Crohn's Disease and Ulcerative Colitis

18+
All Sexes
Montreal, Canada

The goal of this clinical trial is to evaluate whether disease remission can be maintained when biologic therapy is reduced in patients with Crohn"s disease (CD) and ulcerative colitis (UC) taking ustekinumab (UST). The main question it aims to answer is: Can we de-escalate UST subcutaneous dose either from every 4 weeks (Q4) to every 8 weeks (Q8) or every 8 weeks (Q8) to every 12 weeks (Q12) in CD or UC patients in deep remission without loosing their response? Researchers will follow UST blood levels, inflammation markers and intestinal mucosa integrity and to see if UST dose can be reduced while maintaining clinical remission. Participants will: Change UST dosing from Q4 to Q8 or from Q8 to Q12. Visit the clinic once every 12 weeks for checkups and tests.

Phase 4
Recruiting

MUHC - Montreal General Hospital

Janssen Inc.

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Image of Johns Hopkins University School of Medicine in Baltimore, United States.

N-Acetylglucosamine for Crohn's Disease

13 - 80
All Sexes
Baltimore, MD

This study is a clinical trial of oral N-acetylglucosamine (GlcNAc) in patients with Crohn's disease (CD). This study includes two study groups divided by gene variation in a transporter protein that regulates manganese levels. This genetic variant increases the risk of Crohn's disease (especially involving the ileum) and is carried by approximately 10% of individuals with Crohn's disease. This genetic variant lowers manganese levels, and manganese is important in a cellular process called glycosylation, therefore, glycosylation is changed. Glycosylation in the gut controls the barrier function, interactions with the bugs in the gut, and immune function - all important in Crohn's disease. In this study, the investigators will test if this problem with glycosylation can be targeted by giving GlcNAc. GlcNAc is a key ingredient for glycosylation, and it is currently marketed as a dietary supplement in the United States.

Phase 2
Waitlist Available

Johns Hopkins University School of Medicine

Joanna Melia, MD

Image of Jacobs School of Medicine and Biomedical Sciences, Neurology, University at Buffalo in Buffalo, United States.

Mindset Training for MS

18 - 65
All Sexes
Buffalo, NY

People with Multiple Sclerosis (MS) often experience cognitive difficulties such as memory problems, concentration issues, and reduced processing speed. These symptoms can have a negative impact on daily functioning and overall quality of life. Previous research on cognitive rehabilitation has shown that regular training focused on memory and concentration can have positive effects on cognitive functioning, including processing speed, memory, and executive functions that support daily activities. Moreover, fMRI studies (brain scans that measure brain activity) have revealed changes in brain activation following cognitive rehabilitation. Recently, the idea has emerged that a more personalized approach could improve treatment outcomes. Specifically, researchers have identified a link between personality traits and cognitive functioning. Since every individual is different, current cognitive rehabilitation programs often fail to take these personal differences into account. In this project, the investigators aim to enhance the effectiveness of cognitive rehabilitation by focusing more closely on individual characteristics through an app-based training program. Participants will complete a 12-week app training prior to a 6-week cognitive rehabilitation program. The first app focuses on mindset training, supported by a coach. Afterwards, all participants will use a second app designed to train processing speed and memory. In addition to cognitive functioning, the investigators will also examine psychological, (neuro)biological, and social changes using questionnaires and fMRI. This research may provide valuable insights into how cognitive functioning and quality of life in people with MS can be improved. This study is funded by the National MS Fund and is a collaboration between several institutions: the Department of Health, Medical and Neuropsychology at Leiden University (The Netherlands), the University at Buffalo (USA), and Reha Rheinfelden (Switzerland).

Recruiting
1 Prior Treatment

Jacobs School of Medicine and Biomedical Sciences, Neurology, University at Buffalo

Hanneke E Hulst, Prof

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