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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\THIOUREA: 156 Adverse Event Reports & Safety Profile

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156
Total FAERS Reports
0
Deaths Reported
139
Hospitalizations
156
As Primary/Secondary Suspect
3
Life-Threatening
4
Disabilities

Active Ingredient: PROMETHAZINE HYDROCHLORIDE\THIOUREA ·

First Report: 20180130 · Latest Report: 20250318

What Are the Most Common PROMETHAZINE\THIOUREA Side Effects?

#1 Most Reported
Intentional overdose
133 reports (85.3%)
#2 Most Reported
Intentional self-injury
90 reports (57.7%)
#3 Most Reported
Suicide attempt
42 reports (26.9%)

All PROMETHAZINE\THIOUREA Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Intentional overdose 133 85.3% 0 126
Intentional self-injury 90 57.7% 0 88
Suicide attempt 42 26.9% 0 37
Toxicity to various agents 33 21.2% 0 33
Depressed level of consciousness 24 15.4% 0 24
Suicidal ideation 19 12.2% 0 18
Seizure 14 9.0% 0 13
Akathisia 13 8.3% 0 13
Anxiety 10 6.4% 0 10
Tachycardia 10 6.4% 0 10
Serotonin syndrome 9 5.8% 0 8
Fatigue 8 5.1% 0 8
Mydriasis 7 4.5% 0 7
Formication 6 3.9% 0 6
Liver disorder 6 3.9% 0 6
Muscle twitching 6 3.9% 0 6
Sinus tachycardia 6 3.9% 0 6
Blood pressure decreased 5 3.2% 0 5
Bradycardia 5 3.2% 0 5
Cardiac arrest 5 3.2% 0 5

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

Gender: 69.9% female, 30.1% male. Average age: 27.3 years. Most reports from: SE. View detailed demographics →

Is PROMETHAZINE\THIOUREA Getting Safer? Reports by Year

YearReportsDeathsHosp.
2018 12 0 12
2019 13 0 11
2021 31 0 24
2022 16 0 14
2023 43 0 41
2024 30 0 29
2025 5 0 5

View full timeline →

What Is PROMETHAZINE\THIOUREA Used For?

IndicationReports
Product used for unknown indication 139
Sleep disorder 5

PROMETHAZINE\THIOUREA vs Alternatives: Which Is Safer?

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

Official FDA Label for PROMETHAZINE\THIOUREA

Official prescribing information from the FDA-approved drug label.