DOXAZOSIN
Generic: DOXAZOSIN
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.Manufacturer
ORALRoute
DOXAZOSIN MESYLATEActive Substance
2018-02-13Original Approval
DOXAZOSIN is FDA application ANDA205210, sponsored by HERITAGE PHARMA. 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 II2023-02-07
Doxazosin Tablets USP, 8 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729-415-01 UPC 3 16729 41501 9; b) 1,000 TabletsCGMP Deviations: recalling drug products following an FDA inspection.
Class II2023-02-07
Doxazosin Tablets USP 1 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-211-01 UPC 3 16729 21101 7; b) 1,000-couCGMP Deviations: recalling drug products following an FDA inspection.
Class III2026-01-21
Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed by Unichem Pharmaceuticals (USA), Inc., 1 ToTablets/Capsules Imprinted with Wrong ID
Class II2023-03-16
Doxazosin Tablets, USP, 4mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203CGMP Deviations
Class II2023-02-07
Doxazosin Tablets USP, 2 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-414-01 UPC 3 16729 41401 2; b) 1,000-coCGMP Deviations: recalling drug products following an FDA inspection.
Class II2023-02-07
Doxazosin Tablets USP, 4 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-213-01 UPC 3 16729 21301 1; b) 1,000-coCGMP Deviations: recalling drug products following an FDA inspection.
Top Reported Reactions
1
DYSPNOEA
1,659 reports
2
FATIGUE
1,422 reports
3
DIARRHOEA
1,382 reports
4
DIZZINESS
1,382 reports
5
DRUG INEFFECTIVE
1,216 reports
6
NAUSEA
1,169 reports
7
ACUTE KIDNEY INJURY
1,133 reports
8
HEADACHE
1,008 reports
9
HYPOTENSION
997 reports
10
HYPERTENSION
901 reports