ZOTEPINE: 154 Adverse Event Reports & Safety Profile
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154
Total FAERS Reports
40 (26.0%)
Deaths Reported
72
Hospitalizations
154
As Primary/Secondary Suspect
13
Life-Threatening
5
Disabilities
First Report: 20060817 · Latest Report: 20240101
What Are the Most Common ZOTEPINE Side Effects?
#1 Most Reported
Neuroleptic malignant syndrome
36 reports (23.4%)
#2 Most Reported
Drug ineffective
11 reports (7.1%)
#3 Most Reported
Depressed level of consciousness
10 reports (6.5%)
All ZOTEPINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Neuroleptic malignant syndrome | 36 | 23.4% | 15 | 20 |
| Drug ineffective | 11 | 7.1% | 0 | 6 |
| Depressed level of consciousness | 10 | 6.5% | 5 | 5 |
| Pneumonia | 9 | 5.8% | 6 | 2 |
| Colitis ischaemic | 8 | 5.2% | 5 | 6 |
| Dysphagia | 8 | 5.2% | 3 | 4 |
| Extrapyramidal disorder | 8 | 5.2% | 0 | 4 |
| Respiratory failure | 8 | 5.2% | 8 | 3 |
| Salivary hypersecretion | 8 | 5.2% | 4 | 6 |
| Shock | 8 | 5.2% | 5 | 7 |
| Delusion | 7 | 4.6% | 3 | 3 |
| Muscle rigidity | 7 | 4.6% | 3 | 5 |
| Pyrexia | 7 | 4.6% | 2 | 6 |
| Altered state of consciousness | 6 | 3.9% | 1 | 5 |
| Constipation | 6 | 3.9% | 2 | 3 |
| Death | 6 | 3.9% | 6 | 4 |
| Hyperhidrosis | 6 | 3.9% | 3 | 6 |
| Psychiatric symptom | 6 | 3.9% | 2 | 5 |
| Suicide attempt | 6 | 3.9% | 0 | 5 |
| Weight increased | 6 | 3.9% | 1 | 3 |
Who Reports ZOTEPINE Side Effects? Age & Gender Data
Gender: 47.0% female, 53.0% male. Average age: 46.3 years. Most reports from: JP. View detailed demographics →
Is ZOTEPINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2006 | 2 | 2 | 0 |
| 2007 | 1 | 1 | 0 |
| 2008 | 1 | 0 | 1 |
| 2010 | 2 | 0 | 0 |
| 2012 | 4 | 1 | 3 |
| 2013 | 9 | 9 | 3 |
| 2014 | 7 | 2 | 4 |
| 2015 | 2 | 1 | 0 |
| 2016 | 14 | 3 | 8 |
| 2017 | 11 | 0 | 8 |
| 2018 | 5 | 1 | 2 |
| 2019 | 3 | 2 | 1 |
| 2020 | 2 | 0 | 2 |
| 2021 | 2 | 0 | 0 |
| 2022 | 4 | 0 | 2 |
| 2023 | 2 | 0 | 2 |
| 2024 | 1 | 0 | 1 |
What Is ZOTEPINE Used For?
| Indication | Reports |
|---|---|
| Schizophrenia | 49 |
| Product used for unknown indication | 45 |
| Psychotic disorder | 19 |
| Bipolar i disorder | 8 |
| Schizoaffective disorder | 5 |
ZOTEPINE vs Alternatives: Which Is Safer?
ZOTEPINE vs ZUCLOPENTHIXOL
ZOTEPINE vs ZUCLOPENTHIXOL DECANOATE
ZOTEPINE vs ZURANOLONE
ZOTEPINE vs ZYPREXA
ZOTEPINE vs ZYTIGA
ZOTEPINE vs ZYVOX
ZOTEPINE vs 5-FLUOROURACIL
ZOTEPINE vs 5-FU
ZOTEPINE vs 6-ACETYLMORPHINE
ZOTEPINE vs ABACAVIR
Official FDA Label for ZOTEPINE
Official prescribing information from the FDA-approved drug label.