Belimumab

Common brands: Benlysta, Prednisone, Prednisone Delayed Release, Prednisone Tablets, Usp, 10 Mg, Prednisone Tablets, Usp, 20 Mg

Top reporter: Glaxosmithkline Llc

B Lymphocyte Stimulator-specific Inhibitor [EPC]Corticosteroid [EPC]Nonsteroidal Anti-inflammatory Drug [EPC]Folate Analog Metabolic Inhibitor [EPC]Purine Antimetabolite [EPC]
30,863
Total Reports
17,388
Serious Reports
883
Death Reports
30
Reported Reactions
Death Report Ratio: Moderate (2.86%)

Patient Demographics

Male
1,756
Female
23,672

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Belimumab.

# Reaction Reports % of Total
1 PRODUCT DOSE OMISSION ISSUE 4,960
13.1%
2 SYSTEMIC LUPUS ERYTHEMATOSUS 3,858
10.2%
3 FATIGUE 2,033
5.4%
4 DRUG INEFFECTIVE 1,818
4.8%
5 PAIN 1,739
4.6%
6 HEADACHE 1,541
4.1%
7 WRONG TECHNIQUE IN DEVICE USAGE PROCESS 1,477
3.9%
8 NAUSEA 1,476
3.9%
9 MALAISE 1,407
3.7%
10 ARTHRALGIA 1,349
3.6%
11 INJECTION SITE PAIN 1,335
3.5%
12 PRODUCT COMPLAINT 1,260
3.3%
13 OFF LABEL USE 1,065
2.8%
14 CONDITION AGGRAVATED 969
2.6%
15 PYREXIA 965
2.5%
16 ACCIDENTAL EXPOSURE TO PRODUCT 954
2.5%
17 RASH 942
2.5%
18 EXPOSURE VIA SKIN CONTACT 938
2.5%
19 DIARRHOEA 784
2.1%
20 PAIN IN EXTREMITY 763
2.0%
21 PRODUCT STORAGE ERROR 725
1.9%
22 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION 685
1.8%
23 DYSPNOEA 666
1.8%
24 PRODUCT DOSE OMISSION 651
1.7%
25 DIZZINESS 635
1.7%
26 COUGH 627
1.7%
27 URINARY TRACT INFECTION 599
1.6%
28 VOMITING 585
1.5%
29 PNEUMONIA 581
1.5%
30 DEPRESSION 579
1.5%

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.