Leflunomide

Common brands: Arava, Methotrexate, Rasuvo, Otrexup, Trexall

Top reporter: Sanofi-Aventis U.S. Llc

Antirheumatic Agent [EPC]Tumor Necrosis Factor Blocker [EPC]Folate Analog Metabolic Inhibitor [EPC]Corticosteroid [EPC]Nonsteroidal Anti-inflammatory Drug [EPC]
102,951
Total Reports
33,739
Serious Reports
8,823
Death Reports
30
Reported Reactions
Death Report Ratio: High (8.57%)

Patient Demographics

Male
16,631
Female
75,231

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Leflunomide.

# Reaction Reports % of Total
1 DRUG INEFFECTIVE 37,151
9.9%
2 RHEUMATOID ARTHRITIS 25,095
6.7%
3 PAIN 20,249
5.4%
4 ARTHRALGIA 17,141
4.6%
5 DRUG INTOLERANCE 15,735
4.2%
6 JOINT SWELLING 15,730
4.2%
7 FATIGUE 15,547
4.1%
8 RASH 13,498
3.6%
9 OFF LABEL USE 11,975
3.2%
10 ABDOMINAL DISCOMFORT 11,872
3.2%
11 ALOPECIA 11,841
3.2%
12 CONTRAINDICATED PRODUCT ADMINISTERED 11,767
3.1%
13 ARTHROPATHY 10,915
2.9%
14 CONDITION AGGRAVATED 10,504
2.8%
15 SWELLING 10,375
2.8%
16 NAUSEA 10,233
2.7%
17 SYNOVITIS 10,156
2.7%
18 SYSTEMIC LUPUS ERYTHEMATOSUS 9,784
2.6%
19 TREATMENT FAILURE 9,731
2.6%
20 DRUG HYPERSENSITIVITY 9,710
2.6%
21 PERIPHERAL SWELLING 9,286
2.5%
22 DIARRHOEA 9,268
2.5%
23 HYPERSENSITIVITY 9,242
2.5%
24 PEMPHIGUS 9,159
2.4%
25 HEADACHE 9,089
2.4%
26 GLOSSODYNIA 8,473
2.3%
27 HEPATIC ENZYME INCREASED 8,209
2.2%
28 HAND DEFORMITY 8,200
2.2%
29 THERAPEUTIC PRODUCT EFFECT DECREASED 8,022
2.1%
30 MUSCULOSKELETAL STIFFNESS 7,789
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.