OLUMIANT FDA MedWatch Direct Reports Summary

These tables and charts are created from 1,106 voluntary U.S. reports for OLUMIANT (BARICITINIB) reported by individuals to the FDA via the MedWatch Reporting System from 2004 through April 28, 2026.

For a summary of adverse events including mandatory reports submitted by pharmaceutical companies (all countries and all reporter types) to the FAERS database, View FDA FAERS OLUMIANT Report.

Top Adverse Effects Associated with OLUMIANT (from U.S. FDA Medwatch Reports)

	Side Effect	# of FDA Reports
1	THERAPY INTERRUPTED	173
2	THERAPY CESSATION	61
3	ILLNESS	57
4	COVID-19	53
5	SINUSITIS	53
6	INFECTION	44
7	DRUG INEFFECTIVE	43
8	URINARY TRACT INFECTION	39
9	COMMON COLD	35
10	INFLUENZA	34
11	MALAISE	31
12	PNEUMONIA	27
13	RHEUMATOID ARTHRITIS	23
14	INTENTIONAL DOSE OMISSION	22
15	HEADACHE	21
16	BRONCHITIS	20
17	FALL	19
18	PAIN IN EXTREMITY	19
19	NAUSEA	18
20	JOINT PAIN	17
21	CONDITION AGGRAVATED	17
22	SHINGLES	16
23	HOSPITALIZATION	16
24	PAIN	16
25	DIARRHEA	15

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OLUMIANT Total Medwatch Safety Reports by Patient Sex

Male	Female	Unknown	Total
197	892	17	1,106

Medwatch Reporter Type	Count
Consumer	21
Physician	6
Pharmacist	137
Other Health Professional	781
Lawyer	1

Top Indications

Rheumatoid arthritis
Alopecia areata
Product used for unknown indication
HAIR LOSS
ECZEMA

Type of Outcome Reported
Serious: 151
Not Serious: 955
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Suspected Role
Primary Suspect: 1106
Concomitant Drugs: 78
Note: A single MedWatch report can list more than one drug. This summary includes OLUMIANT identified as the suspect drug or as a concomitantly taken drug.

FDA Safety-Related Labeling Changes

OLUMIANT (BARICITINIB) Rx Drug:
FDA Safety-related Labeling Changes

Risk of severe hypoglycemia (low blood sugar) in patients with diabetes

Have experience (good or bad) with OLUMIANT? Rate OLUMIANT at Ask a Patient.

For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.

NOTES

This report, created by AskaPatient.com, is derived from U.S. drug-related adverse event cases that were reported directly to the FDA using the voluntary MedWatch online or paper reporting system. MedWatch is the voluntary FDA system for consumers, physicians, and others to directly report adverse reactions. The Medwatch initiative was launched in 1993 as a voluntary reporting program for consumers, physicians and other healthcare practitioners.

After processing the received forms, the FDA adds the MedWatch reports to the FDA Adverse Events Reporting System(or FAERS database.) Click here for the complete FAERS report summary, which includes mandatory reports submitted by pharmaceutical companies (worldwide) combined with the MedWatch reports. MedWatch Reports only represent about 5% of the FAERS database. For more, read "Does the FDA's Rapidly Growing Database of Adverse Events Improve Drug Safety?"

The data in this report was obtained from Open FDA. Data was last updated to include reports through January 27, 2026. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event.

Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on Open FDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."

FDA uses the "MedDRA" classification system to describe reported adverse reactions. MedDRA is a standardized medical terminology that facilitates sharing of regulatory information internationally. In some cases, "patient friendly" terms for the layman designated by MedDRA have been substituted for medical jargon. Please contact us with questions about this report.