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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.

AMMONIUM\DIPHENHYDRAMINE\SODIUM: 11 Adverse Event Reports & Safety Profile

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11
Total FAERS Reports
3 (27.3%)
Deaths Reported
7
Hospitalizations
11
As Primary/Secondary Suspect

Active Ingredient: AMMONIUM CHLORIDE\DIPHENHYDRAMINE HYDROCHLORIDE\SODIUM CITRATE ·

First Report: 20180101 · Latest Report: 20220710

What Are the Most Common AMMONIUM\DIPHENHYDRAMINE\SODIUM Side Effects?

#1 Most Reported
Weight decreased
5 reports (45.5%)
#2 Most Reported
Therapeutic product effect incomplete
5 reports (45.5%)
#3 Most Reported
Pyrexia
5 reports (45.5%)

All AMMONIUM\DIPHENHYDRAMINE\SODIUM Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Chronic sinusitis 5 45.5% 0 5
Drug ineffective 5 45.5% 0 5
Dyspepsia 5 45.5% 0 5
Infusion related reaction 5 45.5% 0 5
Macular degeneration 5 45.5% 0 5
Malaise 5 45.5% 0 5
Nausea 5 45.5% 0 5
Off label use 5 45.5% 0 5
Pain 5 45.5% 0 5
Paraesthesia oral 5 45.5% 0 5
Procedural pain 5 45.5% 0 5
Pyrexia 5 45.5% 0 5
Therapeutic product effect incomplete 5 45.5% 0 5
Weight decreased 5 45.5% 0 5

Who Reports AMMONIUM\DIPHENHYDRAMINE\SODIUM Side Effects? Age & Gender Data

Gender: 90.0% female, 10.0% male. Average age: 55.3 years. Most reports from: CA. View detailed demographics →

Is AMMONIUM\DIPHENHYDRAMINE\SODIUM Getting Safer? Reports by Year

YearReportsDeathsHosp.
2018 1 0 1
2022 1 0 0

View full timeline →

What Is AMMONIUM\DIPHENHYDRAMINE\SODIUM Used For?

IndicationReports
Product used for unknown indication 10

Official FDA Label for AMMONIUM\DIPHENHYDRAMINE\SODIUM

Official prescribing information from the FDA-approved drug label.