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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.

DIMETHINDENE: 197 Adverse Event Reports & Safety Profile

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197
Total FAERS Reports
47 (23.9%)
Deaths Reported
86
Hospitalizations
197
As Primary/Secondary Suspect
34
Life-Threatening

First Report: 19950105 · Latest Report: 20250623

What Are the Most Common DIMETHINDENE Side Effects?

#1 Most Reported
Fatigue
48 reports (24.4%)
#2 Most Reported
Toxic epidermal necrolysis
32 reports (16.2%)
#3 Most Reported
Erythema
32 reports (16.2%)

All DIMETHINDENE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Fatigue 48 24.4% 7 40
Erythema 32 16.2% 11 22
Toxic epidermal necrolysis 32 16.2% 24 15
Pruritus 26 13.2% 14 17
Pyrexia 25 12.7% 11 18
Death 22 11.2% 22 7
Urticaria 22 11.2% 0 12
Dyspnoea 21 10.7% 8 11
Asthenia 20 10.2% 0 18
Blister 20 10.2% 13 14
Nausea 20 10.2% 7 11
Arthralgia 19 9.6% 7 17
Conjunctivitis 19 9.6% 14 11
Stevens-johnson syndrome 19 9.6% 9 13
Headache 18 9.1% 0 16
Rash 18 9.1% 7 16
Abdominal pain 16 8.1% 7 12
Depression 16 8.1% 0 1
Diarrhoea 16 8.1% 7 13
Drug ineffective 16 8.1% 8 13

Who Reports DIMETHINDENE Side Effects? Age & Gender Data

Gender: 62.1% female, 37.9% male. Average age: 45.6 years. Most reports from: DE. View detailed demographics →

Is DIMETHINDENE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 1 0 1
2001 14 6 10
2004 6 6 4
2011 1 0 0
2012 7 0 3
2014 4 0 0
2015 3 0 1
2016 4 0 4
2017 7 2 4
2018 20 0 12
2019 12 0 9
2020 3 0 1
2021 9 7 8
2022 8 0 7
2023 4 2 0
2025 12 12 0

View full timeline →

What Is DIMETHINDENE Used For?

IndicationReports
Product used for unknown indication 86
Premedication 37
Pruritus 11
Antiallergic therapy 6
Seasonal allergy 5

DIMETHINDENE vs Alternatives: Which Is Safer?

DIMETHINDENE vs DIMETHYL DIMETHINDENE vs DIMETHYL SULFONE DIMETHINDENE vs DINOPROSTONE DIMETHINDENE vs DINUTUXIMAB DIMETHINDENE vs DINUTUXIMAB BETA DIMETHINDENE vs DIOSMIN DIMETHINDENE vs DIOSMIN\HESPERIDIN DIMETHINDENE vs DIOVAN DIMETHINDENE vs DIPHENHYDRAMINE DIMETHINDENE vs DIPHENHYDRAMINE\IBUPROFEN

Official FDA Label for DIMETHINDENE

Official prescribing information from the FDA-approved drug label.