ACETAMINOPHEN\CHLORPHENIRAMINE\PHENYLEPHRINE: 81 Adverse Event Reports & Safety Profile
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81
Total FAERS Reports
5 (6.2%)
Deaths Reported
18
Hospitalizations
81
As Primary/Secondary Suspect
3
Life-Threatening
6
Disabilities
Active Ingredient: ACETAMINOPHEN\CHLORPHENIRAMINE MALEATE\PHENYLEPHRINE HYDROCHLORIDE ·
First Report: 1959 · Latest Report: 20241021
What Are the Most Common ACETAMINOPHEN\CHLORPHENIRAMINE\PHENYLEPHRINE Side Effects?
#1 Most Reported
Drug ineffective
9 reports (11.1%)
#2 Most Reported
Dizziness
6 reports (7.4%)
#3 Most Reported
Diarrhoea
6 reports (7.4%)
All ACETAMINOPHEN\CHLORPHENIRAMINE\PHENYLEPHRINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug ineffective | 9 | 11.1% | 0 | 0 |
| Diarrhoea | 6 | 7.4% | 0 | 1 |
| Dizziness | 6 | 7.4% | 0 | 1 |
| Drug hypersensitivity | 5 | 6.2% | 0 | 1 |
| Somnolence | 5 | 6.2% | 0 | 2 |
Who Reports ACETAMINOPHEN\CHLORPHENIRAMINE\PHENYLEPHRINE Side Effects? Age & Gender Data
Gender: 71.4% female, 28.6% male. Average age: 47.7 years. Most reports from: US. View detailed demographics →
Is ACETAMINOPHEN\CHLORPHENIRAMINE\PHENYLEPHRINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2003 | 1 | 0 | 0 |
| 2008 | 1 | 0 | 0 |
| 2011 | 2 | 0 | 1 |
| 2014 | 1 | 0 | 0 |
| 2015 | 2 | 0 | 2 |
| 2016 | 4 | 1 | 0 |
| 2018 | 4 | 0 | 2 |
| 2019 | 4 | 0 | 0 |
| 2020 | 2 | 0 | 1 |
| 2022 | 1 | 0 | 0 |
| 2023 | 4 | 0 | 0 |
| 2024 | 3 | 1 | 0 |
What Is ACETAMINOPHEN\CHLORPHENIRAMINE\PHENYLEPHRINE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 17 |
| Nasopharyngitis | 12 |
| Hypersensitivity | 11 |
| Headache | 6 |
| Nasal congestion | 6 |
| Rhinorrhoea | 5 |
Official FDA Label for ACETAMINOPHEN\CHLORPHENIRAMINE\PHENYLEPHRINE
Official prescribing information from the FDA-approved drug label.