ACETAMINOPHEN\DIPHENHYDRAMINE\PHENYLEPHRINE: 94 Adverse Event Reports & Safety Profile
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94
Total FAERS Reports
6 (6.4%)
Deaths Reported
9
Hospitalizations
94
As Primary/Secondary Suspect
2
Life-Threatening
1
Disabilities
Active Ingredient: ACETAMINOPHEN\DIPHENHYDRAMINE HYDROCHLORIDE\PHENYLEPHRINE HYDROCHLORIDE ·
First Report: 2011 · Latest Report: 20250706
What Are the Most Common ACETAMINOPHEN\DIPHENHYDRAMINE\PHENYLEPHRINE Side Effects?
#1 Most Reported
Drug ineffective
20 reports (21.3%)
#2 Most Reported
Dyspnoea
8 reports (8.5%)
#3 Most Reported
Insomnia
7 reports (7.4%)
All ACETAMINOPHEN\DIPHENHYDRAMINE\PHENYLEPHRINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug ineffective | 20 | 21.3% | 0 | 2 |
| Dyspnoea | 8 | 8.5% | 1 | 0 |
| Insomnia | 7 | 7.5% | 1 | 0 |
| Nausea | 6 | 6.4% | 1 | 0 |
| Product use in unapproved indication | 6 | 6.4% | 0 | 0 |
| Vomiting | 6 | 6.4% | 1 | 0 |
| Condition aggravated | 5 | 5.3% | 1 | 1 |
| Cough | 5 | 5.3% | 0 | 0 |
| Diarrhoea | 5 | 5.3% | 1 | 0 |
| Drug hypersensitivity | 5 | 5.3% | 0 | 1 |
| Hypersensitivity | 5 | 5.3% | 1 | 1 |
| Malaise | 5 | 5.3% | 0 | 1 |
| Pneumonia | 5 | 5.3% | 1 | 1 |
| Product quality issue | 5 | 5.3% | 0 | 1 |
| Rash | 5 | 5.3% | 1 | 2 |
Who Reports ACETAMINOPHEN\DIPHENHYDRAMINE\PHENYLEPHRINE Side Effects? Age & Gender Data
Gender: 72.6% female, 27.4% male. Average age: 43.4 years. Most reports from: US. View detailed demographics →
Is ACETAMINOPHEN\DIPHENHYDRAMINE\PHENYLEPHRINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2011 | 1 | 0 | 0 |
| 2014 | 5 | 0 | 0 |
| 2015 | 4 | 0 | 1 |
| 2016 | 8 | 0 | 2 |
| 2017 | 10 | 0 | 1 |
| 2018 | 6 | 0 | 0 |
| 2019 | 7 | 3 | 1 |
| 2020 | 2 | 0 | 0 |
| 2023 | 3 | 0 | 0 |
| 2024 | 2 | 0 | 0 |
| 2025 | 3 | 0 | 0 |
What Is ACETAMINOPHEN\DIPHENHYDRAMINE\PHENYLEPHRINE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 33 |
| Cough | 20 |
| Nasopharyngitis | 18 |
| Influenza | 7 |
| Pyrexia | 5 |
Official FDA Label for ACETAMINOPHEN\DIPHENHYDRAMINE\PHENYLEPHRINE
Official prescribing information from the FDA-approved drug label.