METHOTREXATE

Generic: METHOTREXATE SODIUM

Manufacturer: Fresenius Kabi Usa, Llc

Folate Analog Metabolic Inhibitor [EPC]Tumor Necrosis Factor Blocker [EPC]Corticosteroid [EPC]Vitamin C [EPC]Vitamin B12 [EPC]
473,807
Total Reports
153,523
Serious Reports
36,208
Death Reports
30
Reported Reactions
Death Report Ratio: High (7.64%)

Patient Demographics

Male
123,878
Female
302,597

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for METHOTREXATE.

# Reaction Reports % of Total
1 DRUG INEFFECTIVE 91,553
12.7%
2 RHEUMATOID ARTHRITIS 41,872
5.8%
3 ARTHRALGIA 39,751
5.5%
4 PAIN 38,691
5.4%
5 OFF LABEL USE 38,439
5.3%
6 FATIGUE 32,139
4.4%
7 NAUSEA 28,117
3.9%
8 JOINT SWELLING 24,461
3.4%
9 DRUG INTOLERANCE 23,989
3.3%
10 CONDITION AGGRAVATED 23,174
3.2%
11 HEADACHE 22,742
3.1%
12 RASH 21,834
3.0%
13 DIARRHOEA 20,267
2.8%
14 PAIN IN EXTREMITY 19,577
2.7%
15 DRUG HYPERSENSITIVITY 19,384
2.7%
16 PYREXIA 18,371
2.5%
17 PNEUMONIA 17,710
2.5%
18 ALOPECIA 16,968
2.3%
19 VOMITING 16,894
2.3%
20 MALAISE 16,891
2.3%
21 TREATMENT FAILURE 16,851
2.3%
22 DYSPNOEA 15,894
2.2%
23 ABDOMINAL DISCOMFORT 15,824
2.2%
24 NASOPHARYNGITIS 15,101
2.1%
25 INFECTION 14,741
2.0%
26 PERIPHERAL SWELLING 14,587
2.0%
27 MUSCULOSKELETAL STIFFNESS 14,484
2.0%
28 ARTHROPATHY 14,310
2.0%
29 INJECTION SITE PAIN 14,225
2.0%
30 CONTRAINDICATED PRODUCT ADMINISTERED 13,977
1.9%

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.