CHLORPROMAZINE: 3,950 Adverse Event Reports & Safety Profile
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3,950
Total FAERS Reports
671 (17.0%)
Deaths Reported
1,793
Hospitalizations
3,950
As Primary/Secondary Suspect
368
Life-Threatening
94
Disabilities
Approved Prior to Jan 1, 1982
FDA Approved
Alembic Pharmaceuticals Inc.
Manufacturer
Discontinued
Status
Yes
Generic Available
Drug Class: Phenothiazine [EPC] · Route: ORAL · Manufacturer: Alembic Pharmaceuticals Inc. · FDA Application: 009149 · HUMAN PRESCRIPTION DRUG · FDA Label: Available
First Report: 1683 · Latest Report: 20250910
What Are the Most Common CHLORPROMAZINE Side Effects?
#1 Most Reported
Drug ineffective
374 reports (9.5%)
#2 Most Reported
Toxicity to various agents
301 reports (7.6%)
#3 Most Reported
Off label use
288 reports (7.3%)
All CHLORPROMAZINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug ineffective | 374 | 9.5% | 12 | 169 |
| Toxicity to various agents | 301 | 7.6% | 170 | 116 |
| Off label use | 288 | 7.3% | 85 | 197 |
| Drug abuse | 243 | 6.2% | 61 | 122 |
| Overdose | 223 | 5.7% | 99 | 146 |
| Foetal exposure during pregnancy | 190 | 4.8% | 20 | 32 |
| Neuroleptic malignant syndrome | 186 | 4.7% | 10 | 157 |
| Somnolence | 170 | 4.3% | 2 | 101 |
| Neutropenia | 169 | 4.3% | 73 | 105 |
| Seizure | 164 | 4.2% | 77 | 126 |
| Suicide attempt | 163 | 4.1% | 2 | 75 |
| Fatigue | 157 | 4.0% | 73 | 91 |
| Psychotic disorder | 150 | 3.8% | 76 | 119 |
| Condition aggravated | 142 | 3.6% | 3 | 66 |
| Sedation | 141 | 3.6% | 2 | 39 |
| Sopor | 140 | 3.5% | 0 | 100 |
| Extrapyramidal disorder | 135 | 3.4% | 78 | 97 |
| Coma | 131 | 3.3% | 5 | 85 |
| Schizophrenia | 128 | 3.2% | 77 | 96 |
| Nausea | 125 | 3.2% | 70 | 87 |
Who Reports CHLORPROMAZINE Side Effects? Age & Gender Data
Gender: 39.8% female, 60.2% male. Average age: 43.5 years. Most reports from: US. View detailed demographics →
Is CHLORPROMAZINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2000 | 2 | 0 | 0 |
| 2001 | 3 | 0 | 1 |
| 2002 | 6 | 0 | 1 |
| 2003 | 4 | 0 | 2 |
| 2004 | 4 | 1 | 0 |
| 2005 | 2 | 0 | 1 |
| 2006 | 14 | 2 | 9 |
| 2007 | 11 | 1 | 0 |
| 2008 | 3 | 0 | 2 |
| 2009 | 14 | 5 | 10 |
| 2010 | 13 | 3 | 7 |
| 2011 | 15 | 0 | 6 |
| 2012 | 51 | 12 | 18 |
| 2013 | 56 | 19 | 28 |
| 2014 | 85 | 24 | 51 |
| 2015 | 168 | 83 | 126 |
| 2016 | 139 | 10 | 78 |
| 2017 | 206 | 21 | 74 |
| 2018 | 202 | 14 | 124 |
| 2019 | 148 | 33 | 56 |
| 2020 | 121 | 15 | 72 |
| 2021 | 125 | 5 | 92 |
| 2022 | 196 | 39 | 95 |
| 2023 | 119 | 1 | 89 |
| 2024 | 98 | 11 | 34 |
| 2025 | 41 | 0 | 28 |
What Is CHLORPROMAZINE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 1,358 |
| Schizophrenia | 572 |
| Psychotic disorder | 158 |
| Hiccups | 127 |
| Bipolar disorder | 100 |
| Agitation | 96 |
| Bipolar i disorder | 89 |
| Depression | 77 |
| Mental disorder | 47 |
| Suicide attempt | 45 |
CHLORPROMAZINE vs Alternatives: Which Is Safer?
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CHLORPROMAZINE vs CHOLECALCIFEROL\ERGOCALCIFEROL
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