Ustekinumab

Common brands: Stelara, Humira, Methotrexate, Rasuvo, Otrexup

Top reporter: Janssen Biotech, Inc.

Interleukin-12 Antagonist [EPC]Interleukin-23 Antagonist [EPC]Tumor Necrosis Factor Blocker [EPC]Folate Analog Metabolic Inhibitor [EPC]Corticosteroid [EPC]
100,109
Total Reports
41,676
Serious Reports
5,688
Death Reports
30
Reported Reactions
Death Report Ratio: High (5.68%)

Patient Demographics

Male
34,908
Female
51,754

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Ustekinumab.

# Reaction Reports % of Total
1 DRUG INEFFECTIVE 14,579
8.7%
2 OFF LABEL USE 12,465
7.5%
3 PRODUCT DOSE OMISSION ISSUE 9,928
5.9%
4 FATIGUE 6,702
4.0%
5 PSORIASIS 6,500
3.9%
6 PAIN 6,129
3.7%
7 ARTHRALGIA 5,719
3.4%
8 CROHN^S DISEASE 5,689
3.4%
9 RASH 5,537
3.3%
10 PRODUCT USE ISSUE 5,368
3.2%
11 HEADACHE 5,201
3.1%
12 CONDITION AGGRAVATED 5,135
3.1%
13 INFUSION RELATED REACTION 5,041
3.0%
14 RHEUMATOID ARTHRITIS 4,730
2.8%
15 JOINT SWELLING 4,635
2.8%
16 HYPERSENSITIVITY 4,553
2.7%
17 DIARRHOEA 4,542
2.7%
18 ALOPECIA 4,474
2.7%
19 SYNOVITIS 4,473
2.7%
20 HEPATIC ENZYME INCREASED 4,380
2.6%
21 NAUSEA 4,336
2.6%
22 PNEUMONIA 4,267
2.6%
23 PSORIATIC ARTHROPATHY 4,257
2.5%
24 ABDOMINAL DISCOMFORT 4,223
2.5%
25 DRUG INTOLERANCE 4,204
2.5%
26 SYSTEMIC LUPUS ERYTHEMATOSUS 4,131
2.5%
27 LOWER RESPIRATORY TRACT INFECTION 4,099
2.5%
28 WOUND 4,034
2.4%
29 ARTHROPATHY 3,945
2.4%
30 SWELLING 3,927
2.3%

Important Disclaimer

FDA adverse event reports are submitted voluntarily and do not prove causation. A reported reaction does not mean the drug caused it. Drugs with more users naturally have more reports. Always consult your doctor or pharmacist before making medication decisions.