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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.

MAPROTILINE: 209 Adverse Event Reports & Safety Profile

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209
Total FAERS Reports
30 (14.4%)
Deaths Reported
119
Hospitalizations
209
As Primary/Secondary Suspect
9
Life-Threatening
2
Disabilities
Approved Prior to Jan 1, 1982
FDA Approved
Discontinued
Status
Yes
Generic Available

Active Ingredient: MAPROTILINE HYDROCHLORIDE · FDA Application: 017543 ·

First Report: 19970226 · Latest Report: 20231120

What Are the Most Common MAPROTILINE Side Effects?

#1 Most Reported
Constipation
33 reports (15.8%)
#2 Most Reported
Drug ineffective
31 reports (14.8%)
#3 Most Reported
Off label use
29 reports (13.9%)

All MAPROTILINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Constipation 33 15.8% 0 24
Drug ineffective 31 14.8% 0 22
Off label use 29 13.9% 2 24
Conjunctivitis 28 13.4% 0 20
Intestinal obstruction 28 13.4% 0 20
Psoriasis 28 13.4% 0 20
Vision blurred 26 12.4% 0 18
Dry eye 25 12.0% 0 20
Mental disorder 25 12.0% 0 20
Tremor 25 12.0% 1 14
Visual impairment 24 11.5% 0 20
Eye irritation 22 10.5% 0 17
Product use in unapproved indication 20 9.6% 0 15
Dizziness 19 9.1% 1 17
Aspiration 18 8.6% 18 14
Rhabdomyolysis 18 8.6% 0 17
Seizure 17 8.1% 16 12
Tachycardia 17 8.1% 0 17
Depressed level of consciousness 16 7.7% 16 12
Depression 16 7.7% 0 15

Who Reports MAPROTILINE Side Effects? Age & Gender Data

Gender: 79.8% female, 20.2% male. Average age: 58.2 years. Most reports from: ES. View detailed demographics →

Is MAPROTILINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 1 0 1
2005 1 0 0
2009 2 0 2
2010 1 1 0
2011 2 0 1
2012 2 0 1
2013 1 0 0
2014 18 4 14
2015 8 0 4
2016 22 13 18
2017 2 0 1
2018 8 0 8
2019 1 0 0
2020 4 0 4
2021 10 0 1
2022 6 0 0
2023 4 0 0

View full timeline →

What Is MAPROTILINE Used For?

IndicationReports
Depression 72
Product used for unknown indication 63
Insomnia 6
Major depression 6

MAPROTILINE vs Alternatives: Which Is Safer?

MAPROTILINE vs MARALIXIBAT MAPROTILINE vs MARAVIROC MAPROTILINE vs MARIBAVIR MAPROTILINE vs MAVACAMTEN MAPROTILINE vs MEASLES-MUMPS-RUBELLA VIRUS VACCINE MAPROTILINE vs MEASLES VIRUS STRAIN ENDERS' ATTENUATED EDMONSTON LIVE ANTIGEN\MUMPS VIRUS STRAIN B LEVEL JERYL LYNN LIVE ANTIGEN\RUBELLA VIRUS STRAIN WISTAR RA 27/3 LIVE ANTIGEN MAPROTILINE vs MEASLES VIRUS STRAIN ENDERS^ ATTENUATED EDMONSTON LIVE ANTIGEN\MUMPS VIRUS STRAIN B LEVEL JERYL LYNN LIVE ANTIGEN\RUBELLA VIRUS STRAIN WISTAR RA 27/3 LIVE ANTIGEN MAPROTILINE vs MEASLES VIRUS STRAIN ENDERS' ATTENUATED EDMONSTON LIVE ANTIGEN\MUMPS VIRUS STRAIN B LEVEL JERYL LYNN LIVE ANTIGEN\RUBELLA VIRUS STRAIN WISTAR RA 27/3 LIVE ANTIGEN\VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN MAPROTILINE vs MEBENDAZOLE MAPROTILINE vs MEBEVERINE

Official FDA Label for MAPROTILINE

Official prescribing information from the FDA-approved drug label.