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ZEPOSIA is a once-daily pill for adults with moderate to severe ulcerative colitis (UC).

Take as directed by your doctor if certain liver problems exist.

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ZEPOSIA is a once-daily pill for adults with moderate to severe ulcerative colitis (UC).

Take as directed by your doctor if certain liver problems exist.

Safety and side effects

It’s important to know as much as you can when starting a treatment, including its safety information.

ZEPOSIA has a well-established safety profile

The safety of ZEPOSIA has been studied across:

  • 4 clinical studies
  • 2 conditions—ulcerative colitis and multiple sclerosis
  • Over 1,300 patients

At 10 weeks of treatment, 94% of patients remained on ZEPOSIA in the UC clinical studies, and 3.3% stopped due to a side effect they experienced (N=429).

At 1 year of treatment, 80% of patients remained on ZEPOSIA and 1.3% stopped due to a side effect they experienced (N=230).

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ZEPOSIA may cause serious side effects, including:

  • Infections: ZEPOSIA may increase the risk of infections, some serious in nature. Symptoms include fever, feeling very tired, flu-like symptoms, cough, painful and frequent urination (signs of a urinary tract infection), rash, or symptoms of meningitis, such as headache with fever, neck stiffness, sensitivity to light, nausea, or confusion
  • Progressive multifocal leukoencephalopathy (PML): ZEPOSIA can increase your risk for PML, which is a rare brain infection that gets worse over days to weeks, and usually leads to death or severe disability
  • ZEPOSIA may cause your heart rate to temporarily slow down (also known as bradyarrhythmia) when you start taking ZEPOSIA—especially during the first 8 days. To potentially help reduce this, the dosage of ZEPOSIA will be gradually increased during the first 7 days

Contact your healthcare provider right away if you experience the symptoms listed above.

ZEPOSIA may cause serious side effects, including:

  • Liver problems: Symptoms include unexplained nausea, vomiting, stomach area (abdominal) pain, tiredness, loss of appetite, yellowing of the whites of your eyes or skin, or dark colored urine
  • Increased blood pressure: Your healthcare provider should check your blood pressure during treatment with ZEPOSIA. A sudden, severe increase in blood pressure (hypertensive crisis) can happen when you eat certain foods that contain a high level of tyramine
  • Breathing problems: Such as shortness of breath
  • Macular edema (a vision problem): Your risk for macular edema is higher if you have diabetes or have had an inflammation of your eye called uveitis. Symptoms include blurriness, shadows or a blind spot in the center of your vision, sensitivity to light, or unusually colored vision
  • Swelling and narrowing of blood vessels in your brain. Posterior Reversible Encephalopathy Syndrome (or PRES): A rare condition that has happened with ZEPOSIA and with drugs in the same class. Symptoms include sudden severe headache, sudden confusion, sudden loss of vision or other vision changes, or seizure

The safety of ZEPOSIA was evaluated during a one-year, two-part clinical trial. During the clinical trial, people who took ZEPOSIA (n=429) and those who took placebo (n=216) were asked to report any side effects they experienced. All participants were first evaluated at 10 weeks.

Additional information from another clinical study (which included 67 patients who received ZEPOSIA 0.92 mg once daily) is also included in the first table (below).

Here are the most common side effects reported (in a least 2% of ZEPOSIA participants and ≥1% more than placebo), along with the percentages of people who experienced each.

Side effect
(0-9/10 weeks)
ZEPOSIA
496 patients
Placebo
281 patients
Upper respiratory infection 5% 4%
Elevated liver enzymes 5% 0%
Headache 4% 3%
Fever 3% 2%
Nausea 3% 2%
Joint pain 3% 1%

Participants who achieved symptom relief at 10 weeks were able to continue to the second part of the trial, where they were evaluated again after 1 year (ZEPOSIA: n=230; placebo: n=227).

At 1 year, here were the most common side effects reported (in a least 4% of ZEPOSIA participants and ≥1% more than placebo), along with the percentage of people who experienced each.

Side effect
(10-52 weeks)
ZEPOSIA
230 patients
Placebo
227 patients
Elevated liver enzymes 11% 2%
Headache 5% <1%

If you experience any side effects while taking ZEPOSIA, be sure to talk to your doctor right away. These are not all the possible side effects of ZEPOSIA. To see the full list of side effects, click here.

Since it was first approved, approximately 35,000 patients have received ZEPOSIA across two conditions.*

Please see the full Prescribing Information and Medication Guide for information on all of the side effects reported by those taking ZEPOSIA.

  • As of April 30, 2023