What the label lists and what reports show
Baricitinib side effects
Baricitinib's FDA label: “In the 0 to 52-week exposure population, the most commonly reported infections with OLUMIANT were viral upper respiratory tract infection, upper respiratory tract infection, urinary tract infection, and bronchitis.” FAERS holds 9,585 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 pulmonary embolism (309 reports).
- No generic listed
- Boxed warning
Check it at the source: the baricitinib FDA label on DailyMed (effective June 30, 2026, Eli Lilly and Company); 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 OLUMIANT?OLUMIANT may cause serious side effects including: See “ What is the most important information I should know about OLUMIANT? ” The most common side effects of OLUMIANT in people treated for rheumatoid arthritis include: upper respiratory tract infections (common cold, sinus infections) nausea herpes simplex virus infections, including cold sores shingles (herpes zoster) The most common side effects of OLUMIANT in people treated for COVID-19 include: increased liver enzyme levels increased platelets in your blood (thrombocytosis) increased blood creatine phosphokinase low white blood cell count (neutropenia) blood clots in the veins of your legs (DVT) blood clot in your lungs (pulmonary embolism) urinary tract infection The most common side effects of OLUMIANT in people treated for alopecia areata include: upper respiratory tract infections (common cold, sinus infections) headache acne […]
Source: FDA drug label, Eli Lilly and Company, effective June 30, 2026 (SPL set 866e9f35-9035-4581-a4b1-75a621ab55cf), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsIn the 0 to 52-week exposure population, the most commonly reported infections with OLUMIANT were viral upper respiratory tract infection, upper respiratory tract infection, urinary tract infection, and bronchitis.
Table 10: Adverse Reactions That Occurred in ≥1% of Patients Treated with OLUMIANT 2 mg or OLUMIANT 4 mg in Alopecia Areata Trials
| Reaction | Placebo N=371 (%) a | OLUMIANT 2 mg N=365 (%) a | OLUMIANT 4 mg N=540 (%) a |
|---|---|---|---|
| Upper respiratory tract infections b (URTI) | 19.9 | 18.4 | 21.3 |
| Headache | 5.4 | 5.5 | 6.6 |
| Acne c | 2.2 | 5.8 | 5.9 |
| Hyperlipidemia d | 3.0 | 3.6 | 5.9 |
| Blood creatine phosphokinase increased | 1.3 | 0.8 | 4.3 |
| Urinary tract infections (UTI) e | 2.2 | 3.8 | 3.7 |
| Liver enzyme elevations f | 2.4 | 1.1 | 3.0 |
| Folliculitis g | 0.8 | 1.4 | 2.2 |
| Fatigue | 1.1 | 0.8 | 2.2 |
| Lower respiratory tract infections (LRTI) h | 0.8 | 2.2 | 2.0 |
| Nausea | 1.6 | 2.7 | 2.0 |
| Genital Candida infections i | 0.3 | 2.2 | 1.3 |
| Anemia | 0.3 | 0.3 | 1.3 |
| Neutropenia j | 0.8 | 0.3 | 1.3 |
| Abdominal pain k | 2.2 | 3.8 | 0.9 |
| Herpes zoster | 0.5 | 1.4 | 0.9 |
| Weight increased | 0.3 | 1.6 | 0.9 |
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 clinically significant adverse reactions are described elsewhere in the labeling: Serious Infections [see Warnings and Precautions ( 5.1 )] Mortality [see Warnings and Precautions ( 5.2 )] Malignancy and Lymphoproliferative Disorders [see Warnings and Precautions ( 5.3 )] Major Adverse Cardiovascular Events [see Warnings and Precautions ( 5.4 )] Thrombosis [see Warnings and Precautions ( 5.5 )] Hypersensitivity [see Warnings and Precautions ( 5.6 )] Gastrointestinal Perforations [see Warnings and Precautions ( 5.7 )] Hypoglycemia in Patients with Diabetes [see Warnings and Precautions ( 5.8 )] Laboratory Abnormalities [see Warnings and Precautions ( 5.9 )] Adverse reactions reported in clinical trials (≥1%) are: Rheumatoid Arthritis: upper respiratory tract infections (URTIs), nausea, herpes simplex, and herpes zoster.
Source: FDA drug label, Eli Lilly and Company, effective June 30, 2026 (SPL set 866e9f35-9035-4581-a4b1-75a621ab55cf), via openFDA; the full label on DailyMed
What do FAERS reports show?
9,585 reports list baricitinib among the medicines taken, each a report of something that happened, not proof the medicine caused it; 877 are coded as a death and 3,139 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 17 reactions below, 12 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?
- Baricitinib: 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