DORZOLAMIDE HYDROCHLORIDE

Generic: DORZOLAMIDE HYDROCHLORIDE

Sagent PharmaceuticalsManufacturer
OPHTHALMICRoute
DORZOLAMIDE HYDROCHLORIDEActive Substance
2022-01-27Original Approval

DORZOLAMIDE HYDROCHLORIDE is FDA application ANDA215660, sponsored by GLAND. 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 II2026-07-22
Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, 10mL - bottle, Rx only, Manufactured by: Micro La

Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.

Top Reported Reactions

1
TREATMENT FAILURE
1,450 reports
2
DRUG INEFFECTIVE
893 reports
3
OFF LABEL USE
556 reports
4
FATIGUE
484 reports
5
HEADACHE
393 reports
6
EYE IRRITATION
370 reports
7
PAIN
370 reports
8
EYE PAIN
351 reports
9
HYPERSENSITIVITY
334 reports
10
CONDITION AGGRAVATED
313 reports