METHOTREXATE
Generic: METHOTREXATE
Hikma Pharmaceuticals USA Inc.Manufacturer
INTRA-ARTERIAL, INTRAMUSCULAR, INTRATHECAL, INTRAVENOUSRoute
METHOTREXATEActive Substance
1986-09-16Original Approval
METHOTREXATE is FDA application ANDA089342, sponsored by HIKMA. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.
Recalls
Class II2021-03-15
Methotrexate Injection, USP 50 mg/2mL (25 mg/mL) 5 x 2mL Single-Dose Vials, Sterile, Rx Only, Distributed by Hospira, InCGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II2012-06-27
Methotrexate Injection, USP, 25 mg/mL, 40 mL Single Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured forThe affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and
Class III2023-09-22
Methotrexate Tablets, USP, 2.5 mg, 10x10 Unit-Dose Tablets per carton, Rx only, Distributed by: West-Ward PharmaceuticalFailed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two tab
Top Reported Reactions
1
DRUG INEFFECTIVE
92,614 reports
2
RHEUMATOID ARTHRITIS
42,467 reports
3
ARTHRALGIA
40,408 reports
4
OFF LABEL USE
39,859 reports
5
PAIN
39,310 reports
6
FATIGUE
32,749 reports
7
NAUSEA
28,654 reports
8
JOINT SWELLING
24,835 reports
9
DRUG INTOLERANCE
24,385 reports
10
CONDITION AGGRAVATED
23,716 reports