FDA Adverse Events Reports (FAERS) Summary for OLUMIANT

These tables and charts are based on 6,707 total reports for OLUMIANT (BARICITINIB) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through July 30, 2026.

This FAERS total includes 5,593 pharmaceutical company-submitted and non-U.S. FAERS reports and 1,114 U.S. consumer or healthcare provider-submitted MedWatch reports. Adverse events listed on this page represent serious and sometimes rare adverse events reported to pharmaceutical companies, and often do not represent typical side effects for the medication. Find common side effects in the most recent official drug label.

For a separate summary of the 1,114 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	444
2	OFF LABEL USE	290
3	COVID-19	284
4	RHEUMATOID ARTHRITIS	236
5	HEADACHE	198
6	THERAPY INTERRUPTED	175
7	SHINGLES	172
8	NAUSEA	165
9	PNEUMONIA	156
10	PULMONARY EMBOLISM	144
11	JOINT PAIN	141
12	DEATH	140
13	PAIN	139
14	WEIGHT INCREASED	139
15	HAIR LOSS	137
16	FATIGUE	137
17	URINARY TRACT INFECTION	135
18	SHORTNESS OF BREATH	123
19	RASH	117
20	DIARRHEA	109
21	FALL	107
22	SINUSITIS	102
23	COMMON COLD	101
24	DIZZINESS	97
25	ILLNESS	97
26	DEEP VEIN THROMBOSIS	96
27	INFECTION	87
28	PAIN IN EXTREMITY	87
29	FEVER	87
30	VOMITING	87
31	MALAISE	85
32	ANEMIA	81
33	DIVERTICULITIS	73
34	ACNE	72
35	COUGH	72
36	BLOOD CHOLESTEROL INCREASED	70
37	LOWER LIMBS SWELLING	67
38	ITCHING	66
39	BREAST CANCER	65
40	INTERSTITIAL LUNG DISEASE	65
41	THERAPY CESSATION	64
42	ABDOMINAL PAIN UPPER	63
43	ARTHRITIS	62
44	CONDITION AGGRAVATED	62
45	HIGH BLOOD PRESSURE	61
46	HEART ATTACK (MYOCARDIAL INFARCTION)	59
47	INFLUENZA	58
48	WHITE BLOOD CELL COUNT DECREASED	57
49	ATRIAL FIBRILLATION	56
50	CONSTIPATION	56
51	BRONCHITIS	54
52	CHEST PAIN	54
53	CANCER MALIGNANT	54
54	SEPSIS	54
55	ABDOMINAL PAIN	53
56	STROKE	53
57	JOINT SWELLING	50
58	BLOOD PRESSURE INCREASED	49
59	HYPERSENSITIVITY	49
60	ABDOMINAL DISCOMFORT	48
61	ELEVATED LIVER ENZYMES	48
62	BACK PAIN	47
63	LACK OF STRENGTH AND ENERGY (ASTHENIA)	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	LUNG NEOPLASM MALIGNANT	41
72	MATERNAL EXPOSURE DURING PREGNANCY	41
73	THROAT PAIN	41
74	ANXIETY	40
75	GASTROINTESTINAL DISORDER	40
76	BLISTER	38
77	MUSCULOSKELETAL STIFFNESS	38
78	THROMBOSIS	38
79	ORAL HERPES	37
80	HEART FAILURE	36
81	CELLULITIS	36
82	DRUG HYPERSENSITIVITY	36
83	PRODUCT DOSE OMISSION ISSUE	36
84	DRUG INTOLERANCE	35
85	LUNG ADENOCARCINOMA	35
86	RESPIRATORY FAILURE	35
87	ACUTE KIDNEY INJURY	34
88	HAEMOGLOBIN DECREASED	34
89	EXCESS SWEATING	34
90	LUNG DISORDER	34
91	HEART RATE INCREASED	33
92	INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION	33
93	PALPITATIONS	33
94	KIDNEY IMPAIRMENT	33
95	BLOOD CREATINE PHOSPHOKINASE INCREASED	32
96	GAIT DISTURBANCE	32
97	SWELLING OF LIMBS	32
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	3429
2	Patient recovered	1352
3	Patient has not recovered/symtoms have not resolved	1028
4	Patient is recovering/symptoms resolving	619
5	Patient died	405
6	Patient has recovered but has consequent health issues	102

Yearly FDA Adverse Event Reports (Table)

Year	Number of Reports
2012	1
2013	1
2015	1
2016	1
2017	6
2018	253
2019	952
2020	689
2021	791
2022	841
2023	1275
2024	1052
2025	660
2026	184

Reports by Patient Age Group (Table)

Age Group	Number of Reports
0-10	49
11-20	104
21-30	232
31-40	302
41-50	565
51-60	958
61-70	1218
71-80	802
81-90	271
91+	14

Based on 4515 reports that included a patient age.

OLUMIANT Total Reports

Male	Female	Unknown	Total
1604	4463	640	6,707

Top Countries Reporting

	Country	Number of Reports
1	United States	3159
2	Japan	727
3	Germany	644
4	France	424
5	Canada	176
6	Italy	158
7	EU	157
8	United Kingdom	142
9	Spain	110
10	Sweden	110

Outcomes for Reports

Serious: 3976
Not Serious: 2730
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

Events listed on this page represent serious and often rare adverse events reported to pharmaceutical companies, and do not represent typical side effects for the medication. Find common side effects on the most recent official drug label 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 July 30, 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.