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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

LOFEPRAMINE: 48 Adverse Event Reports & Safety Profile

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48
Total FAERS Reports
1 (2.1%)
Deaths Reported
13
Hospitalizations
48
As Primary/Secondary Suspect
6
Life-Threatening
1
Disabilities

First Report: 200104 · Latest Report: 20180307

What Are the Most Common LOFEPRAMINE Side Effects?

#1 Most Reported
Hyponatraemia
14 reports (29.2%)
#2 Most Reported
White blood cell count decreased
8 reports (16.7%)
#3 Most Reported
Tuberculosis of central nervous system
8 reports (16.7%)

All LOFEPRAMINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Hyponatraemia 14 29.2% 0 3
Antipsychotic drug level above therapeutic 8 16.7% 0 8
Tuberculosis of central nervous system 8 16.7% 0 8
White blood cell count decreased 8 16.7% 0 8
Deafness neurosensory 7 14.6% 0 0
Drug ineffective 7 14.6% 0 0
Foetal exposure during pregnancy 7 14.6% 0 0
Inappropriate antidiuretic hormone secretion 7 14.6% 0 0
Labelled drug-drug interaction medication error 7 14.6% 0 7
Vestibular disorder 7 14.6% 0 0
Depression 6 12.5% 0 0
Respiratory depression 6 12.5% 0 0
Anxiety 5 10.4% 0 0

Who Reports LOFEPRAMINE Side Effects? Age & Gender Data

Gender: 56.5% female, 43.5% male. Average age: 54.1 years. Most reports from: GB. View detailed demographics →

Is LOFEPRAMINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 1 0 0
2002 1 0 0
2008 1 0 0
2013 1 0 0
2014 5 0 2
2016 8 0 8
2018 3 0 3

View full timeline →

What Is LOFEPRAMINE Used For?

IndicationReports
Depression 18
Anxiety 8
Tuberculosis of central nervous system 7
Product used for unknown indication 5

Official FDA Label for LOFEPRAMINE

Official prescribing information from the FDA-approved drug label.