Livdelzi® (seladelpar)
What are the possible side effects?
Gilead Sciences, Inc. is providing this letter in response to your unsolicited request for medical information. It is not promotional. It is intended for a US audience 18 years or older.
Gilead Sciences, Inc. is providing this letter in response to your unsolicited request for medical information. It is not promotional. It is intended for a US audience 18 years or older.
LIVDELZI® (seladelpar)
What are the possible side effects of LIVDELZI?
This information is provided in response to your question. It is not treatment advice on how to use LIVDELZI. Please discuss this question and others you have about your medical condition or treatment with your healthcare provider.
Download the LIVDELZI Patient Information for more details, including approved use(s) and important warnings: https://www.gilead.com/-/media/files/pdfs/medicines/pbc/livdelzi/livdelzi_patient_pi.pdf
The short answer1
In the main study, the most common side effect of LIVDELZI was headache. Headache happened in 8% of people, which is 8 in every 100 people.
LIVDELZI may cause serious side effects such as:
| Breaks or cracks in your bones, also called fractures. LIVDELZI can increase your chance of breaking a bone. |
| Changes in liver tests. Taking more LIVDELZI than what your healthcare provider tells you can increase liver enzymes in the blood. |
These are not all the possible side effects of LIVDELZI. Please tell your healthcare provider if you have any side effects.
Who is LIVDELZI for?1
LIVDELZI is a prescription medicine used to treat primary biliary cholangitis, or PBC, in adults. It is approved for use with another medicine for PBC called UDCA in people who have not responded well. It is also approved for use alone if UDCA could not be tolerated.
| People with advanced liver disease, also called decompensated cirrhosis, should not take LIVDELZI. Symptoms may include:
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It is not known if LIVELDZI will prevent advanced liver disease or improve your chance of staying alive.
It is not known if LIVDELZI works well or is safe in children.
What are the common side effects of LIVDELZI?1
The most common side effects of LIVDELZI in the main study were:
- headache
- stomach pain
- nausea
- stomach bloating or swelling
- dizziness
Headache happened in 8% of people, which is 8 in every 100 people. The other common side effects each happened in no more than 7% of people who took LIVDELZI.
These are not all of the possible side effects of LIVDELZI.
What are the serious side effects of LIVDELZI?1
LIVDELZI may cause serious side effects such as:
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These are not all of the possible side effects of LIVDELZI.
Contact your healthcare provider right away if you are concerned about any symptoms you are having or if you think that you might have any of these side effects.
What should I tell my healthcare provider before taking LIVDELZI?1
Before taking LIVDELZI, tell your healthcare provider about all your medical conditions, including if you:
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What should I tell my healthcare provider about the medicines I take before taking LIVDELZI?1
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
| LIVDELZI can affect the way some medicines work. Also, some medicines may affect how LIVDELZI works.
Talk with your healthcare provider before starting a new medication.
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Glossary
Bile ducts: tubes that carry bile between some organs in your body such as the liver. Bile helps to break down fats in the food you eat.
Decompensated cirrhosis: when the liver is so damaged that it can no longer work.
Nausea: feeling sick to the stomach; stomach discomfort and the feeling of wanting to vomit.
Primary biliary cholangitis or PBC: when your immune system attacks the bile ducts in your liver. The ducts become swollen, and over time can become blocked. Bile can back up into your liver and that causes damage.
Ursodeoxycholic acid or UDCA: is a type of medicine to treat PBC. It helps clear bile from the liver.
Reference
- Livdelzi Gilead Sciences Inc. LIVDELZI® (seladelpar) capsules, for oral use. US Prescribing Information. Foster City, CA. Revised August. 2024.
More information about LIVDELZI
If you would like more detailed information about LIVDELZI, please visit:
https://www.gilead.com/-/media/files/pdfs/medicines/pbc/livdelzi/livdelzi_pi.pdf
This is the US FDA-approved Prescribing Information, including the Patient Labeling, for LIVDELZI. It will tell you about the uses, warnings, and other important safety information about LIVDELZI.
Important note
Gilead Sciences, Inc. is providing this letter in response to your unsolicited request for medical information. Some of the information included in this letter may not be covered in the US FDA- approved Prescribing Information for LIVDELZI. Gilead Sciences, Inc. does not intend this letter to be used as medical advice and does not promote use of LIVDELZI in a way that has not been approved by the FDA. Please discuss this question and others you may have about your medical condition or treatment with your healthcare provider.
Follow-Up
For any additional questions, please contact Gilead Medical Information at:
☎1‐866‐MEDI‐GSI (1‐866‐633‐4474) or https://www.patient.askgileadmedical.com/
Reporting side effects
Please report all adverse events to:
Gilead Global Patient Safety ☎ 1-800-445-3235, option 3 or
www.gilead.com/utility/contact/report-an-adverse-event
FDA MedWatch Program by ☎ 1-800-FDA-1088 or MedWatch, FDA, 5600 Fishers Ln, Rockville, MD 20852 or www.accessdata.fda.gov/scripts/medwatch
Data Privacy
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It may be necessary for us to share your information with Gilead’s affiliates, business partners, service providers, and regulatory authorities located in countries besides your own. Gilead Sciences has implemented measures to protect the personal information you provide. Please see the Gilead Privacy Statement (www.gilead.com/privacy-statements) for more information about how Gilead handles your personal information and your rights. If you have any further questions about the use of your personal information, please contact privacy@gilead.com.
LIVDELZI, GILEAD, and the GILEAD logo are registered trademarks of Gilead Sciences, Inc., or its related companies.
© 2025 Gilead Sciences, Inc.
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Do you want to report a side effect or other concern about a Gilead medicine?
Report side effects
To report a side effect or unexpected reaction (sometimes called an “adverse event”) please call 1-800-445-3235 (option #3), available 24 hours a day, 7 days a week.
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To report issues with our products, like defects or package errors, please call 1-800-445-3235 (option #2) available Monday – Friday, 8am – 5pm PT, or email QualityComplaints@gilead.com.
FDA MedWatch
To report a side effect or product quality concern directly to the U.S. Food and Drug Administration (FDA), please call 1-800-FDA-1088 or email www.fda.gov/MedWatch.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns at 1-800-FDA-1088 or www.fda.gov/MedWatch.