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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.

DOXYLAMINE\PYRIDOXINE: 917 Adverse Event Reports & Safety Profile

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917
Total FAERS Reports
30 (3.3%)
Deaths Reported
215
Hospitalizations
917
As Primary/Secondary Suspect
35
Life-Threatening
7
Disabilities

Active Ingredient: DOXYLAMINE SUCCINATE\PYRIDOXINE HYDROCHLORIDE ·

First Report: 1995 · Latest Report: 20250829

What Are the Most Common DOXYLAMINE\PYRIDOXINE Side Effects?

#1 Most Reported
Foetal exposure during pregnancy
216 reports (23.6%)
#2 Most Reported
Maternal exposure during pregnancy
203 reports (22.1%)
#3 Most Reported
Premature baby
199 reports (21.7%)

All DOXYLAMINE\PYRIDOXINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Foetal exposure during pregnancy 216 23.6% 10 37
Maternal exposure during pregnancy 203 22.1% 3 83
Premature baby 199 21.7% 1 25
Nausea 118 12.9% 0 49
Exposure during pregnancy 108 11.8% 0 60
Premature delivery 107 11.7% 0 6
Off label use 99 10.8% 2 29
Diarrhoea 89 9.7% 0 46
Drug ineffective 71 7.7% 0 47
Depression 47 5.1% 0 38
Abortion spontaneous 46 5.0% 1 27
Frequent bowel movements 44 4.8% 0 0
Vomiting 41 4.5% 0 14
Product use issue 40 4.4% 0 6
Somnolence 40 4.4% 0 0
Low birth weight baby 39 4.3% 0 28
Abdominal pain 38 4.1% 0 37
Dehydration 36 3.9% 0 35
Serotonin syndrome 35 3.8% 0 35
Caesarean section 34 3.7% 0 13

Who Reports DOXYLAMINE\PYRIDOXINE Side Effects? Age & Gender Data

Gender: 93.5% female, 6.5% male. Average age: 30.3 years. Most reports from: CA. View detailed demographics →

Is DOXYLAMINE\PYRIDOXINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2008 1 1 0
2012 9 0 6
2013 6 0 2
2014 10 1 7
2015 25 2 4
2016 22 1 3
2017 29 0 2
2018 41 2 3
2019 15 1 1
2020 11 0 7
2021 14 3 4
2022 12 3 1
2023 22 0 2
2024 19 0 2
2025 11 0 2

View full timeline →

What Is DOXYLAMINE\PYRIDOXINE Used For?

IndicationReports
Product used for unknown indication 290
Nausea 147
Morning sickness 135
Prophylaxis 80
Hyperemesis gravidarum 70
Vomiting in pregnancy 61
Foetal exposure during pregnancy 59
Vomiting 50
Type 2 diabetes mellitus 7
Antiemetic supportive care 5

DOXYLAMINE\PYRIDOXINE vs Alternatives: Which Is Safer?

DOXYLAMINE\PYRIDOXINE vs DRONABINOL DOXYLAMINE\PYRIDOXINE vs DRONEDARONE DOXYLAMINE\PYRIDOXINE vs DROPERIDOL DOXYLAMINE\PYRIDOXINE vs DROSPIRENONE DOXYLAMINE\PYRIDOXINE vs DROSPIRENONE\ESTETROL DOXYLAMINE\PYRIDOXINE vs DROSPIRENONE\ESTRADIOL DOXYLAMINE\PYRIDOXINE vs DROSPIRENONE\ETHINYL ESTRADIOL DOXYLAMINE\PYRIDOXINE vs DROSPIRENONE\ETHINYL ESTRADIOL\LEVOMEFOLATE DOXYLAMINE\PYRIDOXINE vs DROTAVERINE DOXYLAMINE\PYRIDOXINE vs DROXIDOPA

Official FDA Label for DOXYLAMINE\PYRIDOXINE

Official prescribing information from the FDA-approved drug label.