What the label lists and what reports show
Mirikizumab side effects
Mirikizumab's FDA label: “Most common adverse reactions are: Ulcerative colitis (≥2%): Induction: upper respiratory tract infections and arthralgia.” FAERS holds 793 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is colitis ulcerative (123 reports).
- No generic listed
- A presentation discontinued
Check it at the source: the mirikizumab FDA label on DailyMed (effective June 16, 2026); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of OMVOH?OMVOH can cause serious side effects, including: See “ What is the most important information I should know about OMVOH? ” The most common side effects of OMVOH in people treated for ulcerative colitis include: upper respiratory infections injection site reactions joint pain headache rash herpes viral infections The most common side effects of OMVOH in people treated for Crohn's disease include: upper respiratory infections injection site reactions elevated liver blood tests headache joint pain Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of OMVOH. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Source: FDA drug label, 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 label list?
From the label: adverse reactionsMost common adverse reactions are: Ulcerative colitis (≥2%): Induction: upper respiratory tract infections and arthralgia.
Table 3: Adverse Reactions a in Subjects with Ulcerative Colitis through Week 40 In a Placebo-Controlled Maintenance Study (UC-2)
| Adverse Reactions | OMVOH 200 mg Subcutaneous Injection b N=389 n (%) | Placebo N=192 n (%) |
|---|---|---|
| Upper respiratory tract infections c | 53 (14%) | 23 (12%) |
| Injection site reactions d | 34 (9%) | 8 (4%) |
| Arthralgia | 26 (7%) | 8 (4%) |
| Rash e | 16 (4%) | 2 (1%) |
| Headache | 16 (4%) | 2 (1%) |
| Herpes viral infection f | 9 (2%) | 1 (1%) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following topics are also discussed in detail in the Warnings and Precautions section: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Infections [see Warnings and Precautions ( 5.2 )] Tuberculosis [see Warnings and Precautions ( 5.3 )] Hepatotoxicity [see Warnings and Precautions ( 5.4 )] Most common adverse reactions are: Ulcerative colitis (≥2%): Induction: upper respiratory tract infections and arthralgia. ( 6.1 ) Maintenance: upper respiratory tract infections, injection site reactions, arthralgia, rash, headache, and herpes viral infection. ( 6.1 ) Crohn's disease (≥5%): upper respiratory tract infections, injection site reactions, headache, arthralgia, and elevated liver tests ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Ulcerative Colitis OMVOH was studied up to 12 weeks in subjects with moderately to severely active ulcerative colitis in a randomized, double-blind, placebo-controlled induction study (UC-1).
Source: FDA drug label, Eli Lilly and Company, effective June 16, 2026 (SPL set 472cbe04-263e-433d-9a0f-58c1b50b715a), via openFDA; the full label on DailyMed
What do FAERS reports show?
793 reports list mirikizumab among the medicines taken, 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. Of the 20 reactions below, 8 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Mirikizumab: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions