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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.

CYCLIZINE: 666 Adverse Event Reports & Safety Profile

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666
Total FAERS Reports
124 (18.6%)
Deaths Reported
223
Hospitalizations
666
As Primary/Secondary Suspect
57
Life-Threatening
52
Disabilities
Approved Prior to Jan 1, 1982
FDA Approved
Discontinued
Status

FDA Application: 009495 ·

First Report: 200911 · Latest Report: 20250523

What Are the Most Common CYCLIZINE Side Effects?

#1 Most Reported
Vomiting
82 reports (12.3%)
#2 Most Reported
Foetal exposure during pregnancy
77 reports (11.6%)
#3 Most Reported
Dizziness
68 reports (10.2%)

All CYCLIZINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Vomiting 82 12.3% 36 73
Foetal exposure during pregnancy 77 11.6% 16 12
Dizziness 68 10.2% 0 15
Mucosal inflammation 63 9.5% 33 36
Neutropenic sepsis 63 9.5% 33 36
Off label use 62 9.3% 7 20
Diarrhoea 61 9.2% 33 59
Dehydration 55 8.3% 33 55
Nausea 54 8.1% 34 38
Headache 53 8.0% 33 53
Anaemia 50 7.5% 33 50
Parkinson's disease 47 7.1% 0 0
Product use in unapproved indication 45 6.8% 28 29
Constipation 43 6.5% 34 39
Death 42 6.3% 42 36
Drug ineffective 42 6.3% 1 14
Dyspnoea 42 6.3% 35 36
Hypokalaemia 42 6.3% 33 42
Dysphagia 40 6.0% 33 36
Neutropenia 40 6.0% 0 13

Who Reports CYCLIZINE Side Effects? Age & Gender Data

Gender: 75.1% female, 24.9% male. Average age: 48.5 years. Most reports from: GB. View detailed demographics →

Is CYCLIZINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2009 23 0 23
2012 1 0 1
2013 12 0 2
2014 31 13 10
2015 13 11 1
2016 11 0 1
2017 80 3 0
2018 7 0 4
2019 18 2 7
2020 76 33 53
2021 21 0 13
2022 7 0 4
2023 27 25 1
2024 4 0 2
2025 1 0 0

View full timeline →

What Is CYCLIZINE Used For?

IndicationReports
Product used for unknown indication 320
Vomiting 122
Nausea 108
Neutropenic sepsis 34
Hyperemesis gravidarum 17
Prophylaxis of nausea and vomiting 15
Foetal exposure during pregnancy 13
Malaise 13
Antiemetic supportive care 9
Maternal exposure timing unspecified 7

CYCLIZINE vs Alternatives: Which Is Safer?

CYCLIZINE vs CYCLOBENZAPRINE CYCLIZINE vs CYCLOPENTOLATE CYCLIZINE vs CYCLOPHOSPHAMIDE CYCLIZINE vs CYCLOPHOSPHAMIDE FOR , USP CYCLIZINE vs CYCLOPHOSPHAMIDE\DOXORUBICIN\PREDNISONE\RITUXIMAB\VINCRISTINE CYCLIZINE vs CYCLOPHOSPHAMIDE\DOXORUBICIN\PREDNISONE\VINCRISTINE CYCLIZINE vs CYCLOSERINE CYCLIZINE vs CYCLOSPORINE CYCLIZINE vs CYMBALTA CYCLIZINE vs CYNODON DACTYLON POLLEN

Official FDA Label for CYCLIZINE

Official prescribing information from the FDA-approved drug label.