BIPERIDEN: 1,808 Adverse Event Reports & Safety Profile
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1,808
Total FAERS Reports
180 (10.0%)
Deaths Reported
1,008
Hospitalizations
1,808
As Primary/Secondary Suspect
188
Life-Threatening
41
Disabilities
Approved Prior to Jan 1, 1982
FDA Approved
Discontinued
Status
Active Ingredient: BIPERIDEN HYDROCHLORIDE · FDA Application: 012003 ·
First Report: 19930101 · Latest Report: 20250627
What Are the Most Common BIPERIDEN Side Effects?
#1 Most Reported
Intentional overdose
164 reports (9.1%)
#2 Most Reported
Neuroleptic malignant syndrome
151 reports (8.4%)
#3 Most Reported
Suicide attempt
133 reports (7.4%)
All BIPERIDEN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Intentional overdose | 164 | 9.1% | 5 | 78 |
| Neuroleptic malignant syndrome | 151 | 8.4% | 24 | 118 |
| Suicide attempt | 133 | 7.4% | 1 | 73 |
| Intentional self-injury | 127 | 7.0% | 0 | 28 |
| Drug ineffective | 124 | 6.9% | 5 | 78 |
| Somnolence | 123 | 6.8% | 6 | 57 |
| Toxicity to various agents | 99 | 5.5% | 17 | 83 |
| Confusional state | 93 | 5.1% | 4 | 63 |
| Pyrexia | 87 | 4.8% | 5 | 72 |
| Intentional product misuse | 86 | 4.8% | 0 | 15 |
| Tremor | 86 | 4.8% | 2 | 44 |
| Sopor | 84 | 4.7% | 0 | 34 |
| Coma | 83 | 4.6% | 1 | 49 |
| Off label use | 75 | 4.2% | 4 | 45 |
| Drug abuse | 71 | 3.9% | 1 | 35 |
| Extrapyramidal disorder | 70 | 3.9% | 2 | 44 |
| Hypotension | 70 | 3.9% | 0 | 49 |
| Agitation | 67 | 3.7% | 1 | 47 |
| Blood creatine phosphokinase increased | 66 | 3.7% | 6 | 53 |
| Drug interaction | 64 | 3.5% | 5 | 42 |
Who Reports BIPERIDEN Side Effects? Age & Gender Data
Gender: 44.7% female, 55.3% male. Average age: 45.1 years. Most reports from: JP. View detailed demographics →
Is BIPERIDEN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2001 | 2 | 0 | 2 |
| 2002 | 1 | 0 | 0 |
| 2003 | 3 | 0 | 3 |
| 2004 | 6 | 1 | 1 |
| 2006 | 5 | 2 | 1 |
| 2007 | 5 | 0 | 3 |
| 2008 | 8 | 0 | 6 |
| 2009 | 8 | 1 | 6 |
| 2010 | 27 | 1 | 26 |
| 2011 | 20 | 3 | 9 |
| 2012 | 17 | 2 | 14 |
| 2013 | 39 | 3 | 30 |
| 2014 | 64 | 7 | 41 |
| 2015 | 63 | 8 | 38 |
| 2016 | 109 | 4 | 70 |
| 2017 | 108 | 8 | 47 |
| 2018 | 88 | 10 | 38 |
| 2019 | 100 | 1 | 45 |
| 2020 | 72 | 1 | 36 |
| 2021 | 74 | 14 | 39 |
| 2022 | 82 | 1 | 48 |
| 2023 | 48 | 1 | 41 |
| 2024 | 37 | 1 | 14 |
| 2025 | 32 | 7 | 14 |
What Is BIPERIDEN Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 861 |
| Schizophrenia | 188 |
| Parkinsonism | 61 |
| Extrapyramidal disorder | 60 |
| Schizoaffective disorder | 37 |
| Bipolar disorder | 32 |
| Dyskinesia | 23 |
| Psychotic disorder | 22 |
| Tremor | 22 |
| Akathisia | 20 |
BIPERIDEN vs Alternatives: Which Is Safer?
BIPERIDEN vs BIRCH TRITERPENES
BIPERIDEN vs BISACODYL
BIPERIDEN vs BISACODYL OR DOCUSATE
BIPERIDEN vs BISMUTH
BIPERIDEN vs BISMUTH SUBCITRATE
BIPERIDEN vs BISMUTH SUBCITRATE\METRONIDAZOLE\TETRACYCLINE
BIPERIDEN vs BISMUTH SUBSALICYLATE
BIPERIDEN vs BISMUTH SUBSALICYLATE\METRONIDAZOLE\TETRACYCLINE
BIPERIDEN vs BISOPROLOL
BIPERIDEN vs BISOPROLOL\BISOPROLOL
Official FDA Label for BIPERIDEN
Official prescribing information from the FDA-approved drug label.