Sulfasalazine

Common brands: Azulfidine En-Tabs, Azulfidine, Methotrexate, Rasuvo, Trexall

Top reporter: Pfizer Laboratories Div Pfizer Inc

Aminosalicylate [EPC]Tumor Necrosis Factor Blocker [EPC]Folate Analog Metabolic Inhibitor [EPC]Corticosteroid [EPC]Antirheumatic Agent [EPC]
76,995
Total Reports
28,799
Serious Reports
6,899
Death Reports
30
Reported Reactions
Death Report Ratio: High (8.96%)

Patient Demographics

Male
15,951
Female
52,549

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Sulfasalazine.

# Reaction Reports % of Total
1 DRUG INEFFECTIVE 29,160
9.4%
2 RHEUMATOID ARTHRITIS 19,331
6.2%
3 PAIN 15,789
5.1%
4 DRUG INTOLERANCE 13,637
4.4%
5 ARTHRALGIA 13,303
4.3%
6 FATIGUE 13,155
4.2%
7 JOINT SWELLING 12,599
4.1%
8 OFF LABEL USE 10,932
3.5%
9 RASH 10,809
3.5%
10 ABDOMINAL DISCOMFORT 9,912
3.2%
11 CONTRAINDICATED PRODUCT ADMINISTERED 9,546
3.1%
12 CONDITION AGGRAVATED 9,477
3.1%
13 ALOPECIA 9,383
3.0%
14 ARTHROPATHY 9,107
2.9%
15 SYNOVITIS 9,051
2.9%
16 TREATMENT FAILURE 8,793
2.8%
17 SYSTEMIC LUPUS ERYTHEMATOSUS 8,707
2.8%
18 SWELLING 8,583
2.8%
19 NAUSEA 8,466
2.7%
20 DRUG HYPERSENSITIVITY 8,364
2.7%
21 PEMPHIGUS 7,923
2.6%
22 GLOSSODYNIA 7,698
2.5%
23 HYPERSENSITIVITY 7,502
2.4%
24 HAND DEFORMITY 7,391
2.4%
25 MUSCULOSKELETAL STIFFNESS 7,387
2.4%
26 INFUSION RELATED REACTION 7,205
2.3%
27 HEPATIC ENZYME INCREASED 6,918
2.2%
28 HEADACHE 6,903
2.2%
29 WOUND 6,826
2.2%
30 THERAPEUTIC PRODUCT EFFECT DECREASED 6,657
2.1%

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.