PROMAZINE: 873 Adverse Event Reports & Safety Profile
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873
Total FAERS Reports
67 (7.7%)
Deaths Reported
443
Hospitalizations
873
As Primary/Secondary Suspect
58
Life-Threatening
12
Disabilities
Approved Prior to Jan 1, 1982
FDA Approved
Discontinued
Status
Yes
Generic Available
Active Ingredient: PROMAZINE HYDROCHLORIDE · FDA Application: 010348 ·
First Report: 20001222 · Latest Report: 20250813
What Are the Most Common PROMAZINE Side Effects?
#1 Most Reported
Sopor
206 reports (23.6%)
#2 Most Reported
Drug abuse
188 reports (21.5%)
#3 Most Reported
Intentional overdose
139 reports (15.9%)
All PROMAZINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Sopor | 206 | 23.6% | 6 | 152 |
| Drug abuse | 188 | 21.5% | 0 | 138 |
| Intentional overdose | 139 | 15.9% | 2 | 30 |
| Intentional self-injury | 135 | 15.5% | 0 | 68 |
| Suicide attempt | 130 | 14.9% | 3 | 28 |
| Somnolence | 93 | 10.7% | 1 | 27 |
| Coma | 63 | 7.2% | 16 | 26 |
| Hypotension | 56 | 6.4% | 1 | 39 |
| Intentional product misuse | 53 | 6.1% | 1 | 4 |
| Overdose | 43 | 4.9% | 8 | 23 |
| Confusional state | 39 | 4.5% | 1 | 17 |
| Off label use | 39 | 4.5% | 2 | 19 |
| Neuroleptic malignant syndrome | 36 | 4.1% | 8 | 31 |
| Suicidal ideation | 35 | 4.0% | 12 | 17 |
| Tachycardia | 34 | 3.9% | 0 | 9 |
| Electrocardiogram qt prolonged | 33 | 3.8% | 4 | 24 |
| Agitation | 28 | 3.2% | 1 | 10 |
| Speech disorder | 28 | 3.2% | 0 | 18 |
| Bradyphrenia | 27 | 3.1% | 0 | 20 |
| Drug ineffective | 25 | 2.9% | 2 | 14 |
Who Reports PROMAZINE Side Effects? Age & Gender Data
Gender: 57.2% female, 42.8% male. Average age: 51.1 years. Most reports from: IT. View detailed demographics →
Is PROMAZINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2000 | 1 | 0 | 1 |
| 2008 | 1 | 0 | 0 |
| 2009 | 1 | 0 | 1 |
| 2010 | 2 | 0 | 2 |
| 2011 | 4 | 0 | 4 |
| 2012 | 6 | 1 | 4 |
| 2013 | 5 | 1 | 3 |
| 2014 | 61 | 13 | 34 |
| 2015 | 41 | 2 | 28 |
| 2016 | 72 | 1 | 36 |
| 2017 | 49 | 6 | 26 |
| 2018 | 60 | 0 | 35 |
| 2019 | 137 | 0 | 62 |
| 2020 | 100 | 1 | 38 |
| 2021 | 37 | 1 | 11 |
| 2022 | 67 | 7 | 44 |
| 2023 | 30 | 0 | 15 |
| 2024 | 32 | 0 | 22 |
| 2025 | 9 | 3 | 3 |
What Is PROMAZINE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 357 |
| Psychotic disorder | 50 |
| Schizophrenia | 48 |
| Bipolar disorder | 47 |
| Drug abuse | 38 |
| Agitation | 24 |
| Intentional self-injury | 20 |
| Personality disorder | 20 |
| Psychomotor hyperactivity | 20 |
| Covid-19 | 16 |
PROMAZINE vs Alternatives: Which Is Safer?
PROMAZINE vs PROMETHAZINE
PROMAZINE vs PROMETHAZINE\PROMETHAZINE
PROMAZINE vs PROMETHAZINE\THIOUREA
PROMAZINE vs PROPAFENONE
PROMAZINE vs PROPARACAINE
PROMAZINE vs PROPECIA
PROMAZINE vs PROPIOMAZINE
PROMAZINE vs PROPOFOL
PROMAZINE vs PROPOXYPHENE
PROMAZINE vs PROPOXYPHENE/ACETAMINOPHEN
Official FDA Label for PROMAZINE
Official prescribing information from the FDA-approved drug label.