AMITRIPTYLINE HYDROCHLORIDE

Generic: AMITRIPTYLINE HYDROCHLORIDE

Aurobindo Pharma LimitedManufacturer
ORALRoute
AMITRIPTYLINE HYDROCHLORIDEActive Substance
1978-04-10Original Approval

AMITRIPTYLINE HYDROCHLORIDE is FDA application ANDA086009, sponsored by AUROBINDO PHARMA USA. 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 III2017-06-16
Amitriptyline HCl Tablets, USP 25 mg, Packaged in a)100-count bottles (NDC 0781-1487-01) and b) 1000-count bottles ( NDC

Cross Contamination With Other Product: Imipramine

Top Reported Reactions

1
PAIN
1,657 reports
2
NAUSEA
1,534 reports
3
HEADACHE
1,476 reports
4
FATIGUE
1,449 reports
5
DYSPNOEA
1,441 reports
6
DIZZINESS
1,225 reports
7
DIARRHOEA
1,184 reports
8
MALAISE
1,100 reports
9
VOMITING
1,063 reports
10
FALL
1,053 reports