FDA Adverse Events Reports (FAERS) Summary for OLUMIANT

These tables and charts are based on 6,594 total reports for OLUMIANT (BARICITINIB) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through April 28, 2026.

This FAERS total includes 5,488 pharmaceutical company-submitted and non-U.S. FAERS reports and 1,106 U.S. consumer or healthcare provider-submitted MedWatch reports. For a separate summary of the 1,106 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch OLUMIANT summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

Top 20 Adverse Effects Associated with OLUMIANT (reported in FAERS Database)

	Side Effect	# of FDA Reports
1	DRUG INEFFECTIVE	438
2	OFF LABEL USE	284
3	COVID-19	283
4	RHEUMATOID ARTHRITIS	233
5	HEADACHE	195
6	THERAPY INTERRUPTED	173
7	SHINGLES	172
8	NAUSEA	162
9	PNEUMONIA	154
10	PULMONARY EMBOLISM	140
11	PAIN	139
12	DEATH	138
13	WEIGHT INCREASED	137
14	JOINT PAIN	136
15	FATIGUE	136
16	HAIR LOSS	135
17	URINARY TRACT INFECTION	134
18	SHORTNESS OF BREATH	121
19	RASH	116
20	DIARRHEA	108
21	FALL	106
22	SINUSITIS	102
23	COMMON COLD	101
24	DIZZINESS	96
25	ILLNESS	96
26	DEEP VEIN THROMBOSIS	94
27	INFECTION	87
28	PAIN IN EXTREMITY	86
29	FEVER	86
30	VOMITING	86
31	MALAISE	83
32	ANEMIA	77
33	ACNE	72
34	COUGH	72
35	DIVERTICULITIS	70
36	BLOOD CHOLESTEROL INCREASED	69
37	LOWER LIMBS SWELLING	66
38	INTERSTITIAL LUNG DISEASE	65
39	BREAST CANCER	64
40	ABDOMINAL PAIN UPPER	63
41	ITCHING	63
42	THERAPY CESSATION	63
43	ARTHRITIS	62
44	CONDITION AGGRAVATED	62
45	HIGH BLOOD PRESSURE	61
46	HEART ATTACK (MYOCARDIAL INFARCTION)	59
47	WHITE BLOOD CELL COUNT DECREASED	57
48	ATRIAL FIBRILLATION	56
49	INFLUENZA	56
50	BRONCHITIS	54
51	CHEST PAIN	54
52	CONSTIPATION	54
53	CANCER MALIGNANT	54
54	ABDOMINAL PAIN	53
55	STROKE	53
56	SEPSIS	53
57	BLOOD PRESSURE INCREASED	49
58	HYPERSENSITIVITY	49
59	JOINT SWELLING	48
60	ABDOMINAL DISCOMFORT	47
61	ELEVATED LIVER ENZYMES	47
62	LACK OF STRENGTH AND ENERGY (ASTHENIA)	45
63	BACK PAIN	45
64	SWELLING	44
65	ALOPECIA AREATA	43
66	DEPRESSION	43
67	UPPER RESPIRATORY TRACT INFECTION	43
68	WEIGHT DECREASED	43
69	ANAPHYLACTIC REACTION	42
70	PINS AND NEEDLES	42
71	THROAT PAIN	41
72	GASTROINTESTINAL DISORDER	40
73	MATERNAL EXPOSURE DURING PREGNANCY	40
74	ANXIETY	38
75	BLISTER	38
76	LUNG NEOPLASM MALIGNANT	38
77	THROMBOSIS	38
78	ORAL HERPES	37
79	MUSCULOSKELETAL STIFFNESS	36
80	HEART FAILURE	35
81	CELLULITIS	35
82	DRUG HYPERSENSITIVITY	35
83	LUNG ADENOCARCINOMA	35
84	PRODUCT DOSE OMISSION ISSUE	35
85	ACUTE KIDNEY INJURY	34
86	EXCESS SWEATING	34
87	LUNG DISORDER	34
88	RESPIRATORY FAILURE	34
89	HEART RATE INCREASED	33
90	INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION	33
91	KIDNEY IMPAIRMENT	33
92	BLOOD CREATINE PHOSPHOKINASE INCREASED	32
93	DRUG INTOLERANCE	32
94	SWELLING OF LIMBS	32
95	PALPITATIONS	32
96	GAIT DISTURBANCE	31
97	HAEMOGLOBIN DECREASED	31
98	PNEUMOCYSTIS JIROVECII PNEUMONIA	31
99	DRUG INTERACTION	30
100	INFLUENZA LIKE ILLNESS	30

Latest Known Outcomes for Reactions Reported for OLUMIANT

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	3365
2	Patient recovered	1323
3	Patient has not recovered/symtoms have not resolved	991
4	Patient is recovering/symptoms resolving	605
5	Patient died	400
6	Patient has recovered but has consequent health issues	101

Search all MedWatch and FAERS by keyword:

OLUMIANT Total Reports

Male	Female	Unknown	Total
1571	4394	629	6,594

Top Countries Reporting

	Country	Number of Reports
1	United States	3122
2	Japan	708
3	Germany	645
4	France	425
5	Canada	176
6	Italy	158
7	United Kingdom	142
8	Spain	111
9	Sweden	110
10	EU	105

Outcomes for Reports

Serious: 3885
Not Serious: 2708
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Top Indications

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

Top Companies Reporting

ELI LILLY AND COMPANY
ELI LILLY AND CO

Safety-Related FDA Updates

FDA Approval Date: 2018-05-31

OLUMIANT (BARICITINIB) Rx Drug:
Risk of severe hypoglycemia (low blood sugar) in patients with diabetes Safety-related Labeling Changes

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 the cases for OLUMIANT reported to the United States Food and Drug Administration (FDA) FDA Safety Information and Adverse Event Reporting System (FAERS) and obtained from Open FDA. Data was last updated with reports received through April 28, 2026.

This summary includes ALL reports where the drug is a "primary OR secondary OR suspected interacting" drug. Typically, reports are filed for the most serious type or "event" and do not represent incidental or minor side effects. The majority of these reports are mandatory reports submitted by pharmaceutical companies, who receive complaints from consumers. 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. This report also features counts of latest known outcomes associated with reported side effects, but does not provide the specific outcomes for specific adverse events.

Adverse Event Reports are submitted to the FAERS database by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers). Health care providers such as doctors (voluntary reporting), and patients themselves (voluntary reporting) report to the FDA directly through the MedWatch program. Those MedWatch reports are coded and included in the FAERS database. This report mainly consists of the mandatory reports, because the MedWatch reports are a small percentage (3 - 5%) of total reports. Link to the MedWatch summary report at the top of the page for a summary of the directly reported (voluntary) adverse events for this drug.The number of reports included here might differ somewhat from the number of reports in the downloadable quarterly FAERS reports and in the online FAERS dashboard, due to lags in reporting, drug name differences, duplicates, and other factors. Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on openFDA 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 or comments about this report.