Prescription medicine
Mirikizumab Brand names: Omvoh
Mirikizumab (Omvoh) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
- A presentation discontinued
Check it at the source: the mirikizumab FDA label on DailyMed (effective June 16, 2026); every mirikizumab label on DailyMed.
Highlights of the record
FDA label of June 16, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageOMVOH is indicated for the treatment of: moderately to severely active ulcerative colitis in adults.
Forms and strengths
- 20 mg/ml
- 100 mg/ml
Injection (solution); kit.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- None current 2 past records
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 793 through July 30, 2026
What is mirikizumab used for?
From the label: indications and usageOMVOH is indicated for the treatment of: moderately to severely active ulcerative colitis in adults. moderately to severely active Crohn's disease in adults. OMVOH TM is an interleukin-23 antagonist indicated for the treatment of: moderately to severely active ulcerative colitis in adults ( 1 ) moderately to severely active Crohn's disease in adults
FDA pharmacologic class: Interleukin-23 Antagonist.
Source: FDA drug label (Omvoh), Eli Lilly and Company, effective June 16, 2026 (SPL set 472cbe04-263e-433d-9a0f-58c1b50b715a), via openFDA; the full label on DailyMed
What does the patient leaflet for mirikizumab say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about OMVOH?OMVOH can cause serious side effects, including: Serious allergic reactions. OMVOH may cause serious allergic reactions that may need to be treated in a hospital and may be life-threatening. Stop using OMVOH and get emergency medical help right away if you develop any of the following symptoms of a serious allergic reaction: fainting, dizziness, feeling lightheaded (low blood pressure) swelling of your face, eyelids, lips, mouth, tongue, throat, or trouble swallowing trouble breathing, throat tightening or wheezing chest tightness fast heartbeat or pounding in your chest (tachycardia) severe itching, hives, or redness all over your body sweating Infections. OMVOH may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should not start treatment with OMVOH until your infection is gone. Before starting your treatment with OMVOH, your healthcare provider should test you for tuberculosis (TB). If your healthcare provider feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with OMVOH. Your healthcare provider should watch you closely for signs and symptoms of TB while you are being treated with OMVOH and after treatment. Before starting OMVOH, tell your healthcare provider if you think you have an infection or have symptoms of an infection such as: fever, sweating, or chills muscle aches and pain cough or shortness of breath blood in your mucus (phlegm) flu-like symptoms headache warm, red, or painful skin or sores on your body diarrhea or stomach pain weight loss nausea or vomiting pain during urination After starting OMVOH, tell your healthcare provider right away if you have any symptoms of an infection. Liver problems. […]
From the patient leaflet: How should I store OMVOH?In the original carton, store OMVOH prefilled pens and prefilled syringes in a refrigerator between 36°F to 46°F (2°C to 8°C). Do not freeze. Do not use OMVOH if it has been frozen. Do not shake. Keep OMVOH in the original carton to protect from light until the time of use. If needed, your prefilled pens or prefilled syringes may be stored at room temperature for up to 2 weeks in the original carton. Do not store above 86°F (30°C). When OMVOH has been stored at room temperature, do not return it to the refrigerator. Do not use and throw away (dispose of) your prefilled pens and prefilled syringes if they: have been frozen. have been shaken. have not been protected from light in the original carton. have been stored at room temperature more than 2 weeks. Keep OMVOH and all medicines out of the reach of children.
Source: FDA drug label (Omvoh), Eli Lilly and Company, effective June 16, 2026 (SPL set 472cbe04-263e-433d-9a0f-58c1b50b715a), via openFDA; the full label on DailyMed
Is there a generic for mirikizumab (Omvoh)?
No generic mirikizumab is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is mirikizumab in shortage?
No mirikizumab presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 2 records are all marked to be discontinued, the latest updated December 22, 2025. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Omvoh, Injection, 100 mg/1 mL (NDC 0002-8011-27) | Eli Lilly and Co. | To Be Discontinued | December 22, 2025 |
| Omvoh, Injection, 100 mg/1 mL (NDC 0002-8870-27) | Eli Lilly and Co. | To Be Discontinued | December 22, 2025 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
What do FAERS reports show for mirikizumab?
The FDA Adverse Event Reporting System holds 793 reports that list mirikizumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 26 are coded as a death and 163 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other interleukin-23 antagonists
- the pharmacologic class, with prices and generics
- Mirikizumab side effects
- the label's list beside FAERS reports
- Mirikizumab shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other