DEXTROMETHORPHAN HYDROBROMIDE\PROMETHAZINE: 54 Adverse Event Reports & Safety Profile
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54
Total FAERS Reports
1 (1.9%)
Deaths Reported
11
Hospitalizations
54
As Primary/Secondary Suspect
1
Life-Threatening
5
Disabilities
Active Ingredient: DEXTROMETHORPHAN HYDROBROMIDE\PROMETHAZINE HYDROCHLORIDE ·
First Report: 20140215 · Latest Report: 20250304
What Are the Most Common DEXTROMETHORPHAN HYDROBROMIDE\PROMETHAZINE Side Effects?
#1 Most Reported
Dyspnoea
5 reports (9.3%)
#2 Most Reported
Drug ineffective
4 reports (7.4%)
#3 Most Reported
Somnolence
3 reports (5.6%)
All DEXTROMETHORPHAN HYDROBROMIDE\PROMETHAZINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Dyspnoea | 5 | 9.3% | 0 | 0 |
Who Reports DEXTROMETHORPHAN HYDROBROMIDE\PROMETHAZINE Side Effects? Age & Gender Data
Gender: 78.8% female, 21.2% male. Average age: 57.9 years. Most reports from: US. View detailed demographics →
Is DEXTROMETHORPHAN HYDROBROMIDE\PROMETHAZINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2014 | 3 | 0 | 0 |
| 2015 | 3 | 0 | 0 |
| 2016 | 2 | 0 | 0 |
| 2017 | 4 | 0 | 0 |
| 2018 | 3 | 0 | 0 |
| 2019 | 2 | 0 | 0 |
| 2020 | 2 | 0 | 2 |
| 2021 | 1 | 0 | 0 |
| 2023 | 2 | 0 | 0 |
| 2024 | 8 | 0 | 2 |
| 2025 | 4 | 0 | 1 |
What Is DEXTROMETHORPHAN HYDROBROMIDE\PROMETHAZINE Used For?
| Indication | Reports |
|---|---|
| Cough | 24 |
| Product used for unknown indication | 13 |
Official FDA Label for DEXTROMETHORPHAN HYDROBROMIDE\PROMETHAZINE
Official prescribing information from the FDA-approved drug label.