LEFLUNOMIDE
Generic: LEFLUNOMIDE
KVK-TechManufacturer
ORALRoute
LEFLUNOMIDEActive Substance
2019-06-03Original Approval
LEFLUNOMIDE is FDA application ANDA212453, sponsored by ABHAI LLC. 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 II2007-06-14
Leflunomide tablets, 10 mg, a) 30-count bottle (NDC 60505-2502-1), b) 1000-count bottle (NDC 60505-2502-3), Rx only, ManSubpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
Class II2007-06-14
Leflunomide tablets, 20 mg, 1000-count bottle, Rx only, Manufactured for Apotex Corp., Weston, Florida 33326 by Apotex ISubpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
Top Reported Reactions
1
DRUG INEFFECTIVE
23,255 reports
2
RHEUMATOID ARTHRITIS
16,148 reports
3
PAIN
13,275 reports
4
ARTHRALGIA
11,948 reports
5
JOINT SWELLING
11,710 reports
6
DRUG INTOLERANCE
11,457 reports
7
FATIGUE
10,829 reports
8
RASH
10,258 reports
9
OFF LABEL USE
9,477 reports
10
SYNOVITIS
8,590 reports