ENBREL

Generic: ETANERCEPT

Manufacturer: Immunex Corporation

Tumor Necrosis Factor Blocker [EPC]Folate Analog Metabolic Inhibitor [EPC]Corticosteroid [EPC]Antirheumatic Agent [EPC]Nonsteroidal Anti-inflammatory Drug [EPC]
591,577
Total Reports
67,663
Serious Reports
16,506
Death Reports
30
Reported Reactions
Death Report Ratio: Moderate (2.79%)

Patient Demographics

Male
139,057
Female
407,742

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for ENBREL.

# Reaction Reports % of Total
1 DRUG INEFFECTIVE 75,053
9.7%
2 INJECTION SITE PAIN 56,664
7.3%
3 RHEUMATOID ARTHRITIS 46,177
6.0%
4 ARTHRALGIA 44,969
5.8%
5 PAIN 43,004
5.6%
6 INJECTION SITE ERYTHEMA 41,016
5.3%
7 FATIGUE 30,270
3.9%
8 PAIN IN EXTREMITY 25,461
3.3%
9 JOINT SWELLING 25,430
3.3%
10 PSORIASIS 24,972
3.2%
11 HEADACHE 24,669
3.2%
12 INJECTION SITE SWELLING 23,258
3.0%
13 OFF LABEL USE 22,112
2.9%
14 INJECTION SITE PRURITUS 22,089
2.9%
15 INJECTION SITE REACTION 20,860
2.7%
16 NASOPHARYNGITIS 20,626
2.7%
17 CONDITION AGGRAVATED 20,536
2.7%
18 RASH 20,059
2.6%
19 NAUSEA 19,208
2.5%
20 MALAISE 18,593
2.4%
21 DRUG INTOLERANCE 16,623
2.2%
22 SINUSITIS 16,469
2.1%
23 DRUG HYPERSENSITIVITY 14,816
1.9%
24 MUSCULOSKELETAL STIFFNESS 14,470
1.9%
25 ARTHROPATHY 14,310
1.9%
26 ALOPECIA 14,240
1.8%
27 PERIPHERAL SWELLING 14,133
1.8%
28 HYPERSENSITIVITY 13,867
1.8%
29 INJECTION SITE BRUISING 13,721
1.8%
30 DIARRHOEA 13,590
1.8%

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.