CALCITRIOL

Generic: CALCITRIOL

Patrin PharmaManufacturer
ORALRoute
CALCITRIOLActive Substance
2023-07-28Original Approval

CALCITRIOL is FDA application ANDA203973, sponsored by ANDA REPOSITORY. 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 II2014-05-01
Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-3120-

Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at th

Top Reported Reactions

1
NAUSEA
1,447 reports
2
DIARRHOEA
1,174 reports
3
OFF LABEL USE
1,132 reports
4
CHRONIC KIDNEY DISEASE
1,111 reports
5
VOMITING
1,090 reports
6
DYSPNOEA
1,068 reports
7
RENAL FAILURE
1,056 reports
8
FATIGUE
1,018 reports
9
ACUTE KIDNEY INJURY
956 reports
10
DEATH
892 reports