ACETAMINOPHEN\CAFFEINE\PHENYLEPHRINE: 63 Adverse Event Reports & Safety Profile
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63
Total FAERS Reports
0
Deaths Reported
31
Hospitalizations
63
As Primary/Secondary Suspect
5
Life-Threatening
2
Disabilities
Active Ingredient: ACETAMINOPHEN\CAFFEINE\PHENYLEPHRINE HYDROCHLORIDE ·
First Report: 20110730 · Latest Report: 20221013
What Are the Most Common ACETAMINOPHEN\CAFFEINE\PHENYLEPHRINE Side Effects?
#1 Most Reported
Vomiting
10 reports (15.9%)
#2 Most Reported
Product prescribing error
10 reports (15.9%)
#3 Most Reported
Intentional overdose
10 reports (15.9%)
All ACETAMINOPHEN\CAFFEINE\PHENYLEPHRINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug interaction | 10 | 15.9% | 0 | 10 |
| General physical health deterioration | 10 | 15.9% | 0 | 10 |
| Intentional overdose | 10 | 15.9% | 0 | 10 |
| Product prescribing error | 10 | 15.9% | 0 | 10 |
| Vomiting | 10 | 15.9% | 0 | 6 |
| Suicide attempt | 9 | 14.3% | 0 | 9 |
| Nausea | 8 | 12.7% | 0 | 0 |
| Balance disorder | 7 | 11.1% | 0 | 6 |
| Hypotension | 7 | 11.1% | 0 | 7 |
| Abdominal pain upper | 6 | 9.5% | 0 | 1 |
| Blood calcium decreased | 6 | 9.5% | 0 | 6 |
| Cognitive disorder | 6 | 9.5% | 0 | 6 |
| Constipation | 6 | 9.5% | 0 | 6 |
| Creatinine renal clearance decreased | 6 | 9.5% | 0 | 6 |
| Depressed level of consciousness | 6 | 9.5% | 0 | 6 |
| Diarrhoea | 6 | 9.5% | 0 | 0 |
| Fall | 6 | 9.5% | 0 | 6 |
| Malaise | 6 | 9.5% | 0 | 0 |
| Mobility decreased | 6 | 9.5% | 0 | 6 |
| Orthostatic hypotension | 6 | 9.5% | 0 | 6 |
Who Reports ACETAMINOPHEN\CAFFEINE\PHENYLEPHRINE Side Effects? Age & Gender Data
Gender: 93.8% female, 6.3% male. Average age: 50.3 years. Most reports from: GB. View detailed demographics →
Is ACETAMINOPHEN\CAFFEINE\PHENYLEPHRINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2011 | 1 | 0 | 1 |
| 2014 | 2 | 0 | 1 |
| 2015 | 12 | 0 | 10 |
| 2016 | 9 | 0 | 1 |
| 2017 | 5 | 0 | 1 |
| 2018 | 6 | 0 | 0 |
| 2019 | 5 | 0 | 0 |
| 2020 | 2 | 0 | 0 |
| 2021 | 8 | 0 | 8 |
| 2022 | 2 | 0 | 2 |
What Is ACETAMINOPHEN\CAFFEINE\PHENYLEPHRINE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 24 |
| Nasopharyngitis | 16 |
| Pain | 5 |
Official FDA Label for ACETAMINOPHEN\CAFFEINE\PHENYLEPHRINE
Official prescribing information from the FDA-approved drug label.