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Immunomodulators

Editorial Team's avatar image

By Editorial Team

3 min read

Reviewed by: HU Medical Review Board | Last reviewed: January 2025 | Last updated: January 2025

Inflammatory bowel disease (IBD) is a group of chronic digestive conditions that include Crohn’s disease and ulcerative colitis (UC). IBD cannot be cured, but there are many drugs used to treat its symptoms.1

The goal of IBD treatment is to achieve remission. This means that symptoms – caused by inflammation in the intestines – are controlled and you have no disease flares.2

Immunomodulators are one group of medicines used to control IBD inflammation. This type of drug is prescribed to help people achieve long-term remission.1-3

How do immunomodulators work for IBD?

To decrease inflammation, immunomodulators change the way your immune system works. This group of drugs is often used to stop the body from attacking itself in people with autoimmune diseases like rheumatoid arthritis, psoriasis, and IBD. Doctors also prescribe these drugs to people after organ transplants so their bodies will not reject the new organ.2,3

Your doctor may prescribe an immunomodulator to:2

  • Control symptoms not controlled by aminosalicylates, antibiotics, or steroids
  • Reduce the need for steroids
  • Treat abnormal channels between the intestines and other body parts (fistulas)
  • Boost the effect of a biologic drug or prevent resistance to a biologic drug
  • Prevent symptoms after surgery

It takes immunomodulators 1 to 6 months, or longer, to work. So, they may be combined with faster-acting drugs such as a steroid or biologic when first given.1-3

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Examples of immunomodulators for IBD

There are several immunomodulators prescribed to treat Crohn’s disease and UC, including:4

  • Azathioprine (Imuran®)
  • Mercaptopurine (Purinethol®)
  • Cyclosporine (Neoral®, Sandimmune®)
  • Methotrexate (Jylamvo®, Otrexup®, Rasuvo®, Xatmep®)
  • Tacrolimus (Prograf®)

Immunomodulators may be prescribed as a pill or injection.2

What are the possible side effects?

Side effects can vary depending on the specific drug you are taking. Common side effects of immunomodulators are wide-ranging and include:2,3

  • Nausea and vomiting
  • Fatigue, discomfort, or lack of interest (malaise)
  • Infections
  • Headache
  • Tremor
  • High blood pressure
  • Extra hair growth
  • Low white blood cell count

Azathioprine has a black box warning, the strictest warning from the US Food and Drug Administration (FDA). It has this warning because it increases the risk of cancer.5

Cyclosporine has a black box warning because it must be given under special circumstances to people who have had an organ transplant. It also can build up to toxic levels in the body, so it needs close monitoring by a doctor.6

Methotrexate has a black box warning because it can harm a fetus, raise the risk of infection, and cause serious problems with the bone marrow, kidneys, liver, nervous system, gastrointestinal tract, lungs, and skin. In some cases, these problems lead to death.7

Tacrolimus has a boxed warning because it increases the risk of serious infections and cancer.8

These are not all the possible side effects of immunomodulators. Talk to your doctor about what to expect when taking immunomodulators. You also should call your doctor if you have any changes that concern you when taking immunomodulators.

Other things to know

Because immunomodulators reduce activity of the immune system, you may get infections more easily. Talk to your doctor about any vaccines that may be recommended to reduce your risk of infection. Be sure to call your doctor if you have fever, chills, or a sore throat.2,6-8

Some immunomodulators affect your liver and kidney function. You will need regular blood tests to monitor your bone marrow, liver, and kidney function while taking immunomodulators.2,3,6,7

Methotrexate is not safe to take while pregnant. Both men and women should stop taking methotrexate for several months before trying to get pregnant.2,7

Your doctor may suggest you take folic acid to reduce the side effects of methotrexate. Because of its possible dangerous side effects, your doctor will monitor you closely while you take it.2,7

Before beginning treatment for Crohn’s disease or ulcerative colitis, tell your doctor about all your health conditions and any other drugs, vitamins, or supplements you take. This includes over-the-counter drugs.

Other drugs that may be prescribed for IBD include:1

  • Antibiotics
  • Corticosteroids
  • Aminosalicylates (5-ASAs)