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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.

PROMETHAZINE\PROMETHAZINE: 1,488 Adverse Event Reports & Safety Profile

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1,488
Total FAERS Reports
671 (45.1%)
Deaths Reported
491
Hospitalizations
1,488
As Primary/Secondary Suspect
165
Life-Threatening
22
Disabilities

Active Ingredient: PROMETHAZINE\PROMETHAZINE HYDROCHLORIDE ·

First Report: 2000 · Latest Report: 20190611

What Are the Most Common PROMETHAZINE\PROMETHAZINE Side Effects?

#1 Most Reported
Toxicity to various agents
384 reports (25.8%)
#2 Most Reported
Completed suicide
242 reports (16.3%)
#3 Most Reported
Drug abuse
197 reports (13.2%)

All PROMETHAZINE\PROMETHAZINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Toxicity to various agents 384 25.8% 268 124
Completed suicide 242 16.3% 242 52
Drug abuse 197 13.2% 174 20
Overdose 109 7.3% 38 50
Death 88 5.9% 88 5
Vomiting 85 5.7% 4 50
Nausea 64 4.3% 1 25
Suicide attempt 58 3.9% 3 44
Drug interaction 54 3.6% 10 27
Drug ineffective 51 3.4% 0 24
Intentional overdose 51 3.4% 10 39
Diarrhoea 49 3.3% 3 28
Somnolence 49 3.3% 1 18
Foetal exposure during pregnancy 48 3.2% 12 12
Confusional state 43 2.9% 0 21
Fatigue 43 2.9% 0 17
Serotonin syndrome 42 2.8% 0 30
Agitation 41 2.8% 1 20
Cardio-respiratory arrest 41 2.8% 36 17
Drug hypersensitivity 41 2.8% 0 9

Who Reports PROMETHAZINE\PROMETHAZINE Side Effects? Age & Gender Data

Gender: 63.7% female, 36.3% male. Average age: 41.7 years. Most reports from: US. View detailed demographics →

Is PROMETHAZINE\PROMETHAZINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 1 0 1
2003 1 0 1
2004 3 0 1
2005 5 0 4
2007 3 2 1
2008 2 0 0
2009 3 0 1
2010 6 2 3
2011 11 2 8
2012 12 12 0
2013 85 60 22
2014 67 28 25
2015 65 16 22
2016 98 17 38
2017 111 12 38
2018 88 30 30
2019 22 0 15

View full timeline →

What Is PROMETHAZINE\PROMETHAZINE Used For?

IndicationReports
Product used for unknown indication 836
Nausea 93
Sleep disorder 33
Vomiting 26
Schizophrenia 17
Suicide attempt 17
Depression 15
Foetal exposure during pregnancy 14
Insomnia 10
Anxiety disorder 9

PROMETHAZINE\PROMETHAZINE vs Alternatives: Which Is Safer?

PROMETHAZINE\PROMETHAZINE vs PROMETHAZINE\THIOUREA PROMETHAZINE\PROMETHAZINE vs PROPAFENONE PROMETHAZINE\PROMETHAZINE vs PROPARACAINE PROMETHAZINE\PROMETHAZINE vs PROPECIA PROMETHAZINE\PROMETHAZINE vs PROPIOMAZINE PROMETHAZINE\PROMETHAZINE vs PROPOFOL PROMETHAZINE\PROMETHAZINE vs PROPOXYPHENE PROMETHAZINE\PROMETHAZINE vs PROPOXYPHENE/ACETAMINOPHEN PROMETHAZINE\PROMETHAZINE vs PROPRANOLOL PROMETHAZINE\PROMETHAZINE vs PROPRANOLOL\PROPRANOLOL

Official FDA Label for PROMETHAZINE\PROMETHAZINE

Official prescribing information from the FDA-approved drug label.