ACETAMINOPHEN\PHENYLEPHRINE: 99 Adverse Event Reports & Safety Profile
Grow Your Own Natural Pharmacy at Home
Medicinal Garden Kit — 10 healing herbs, 4,818 seeds + step-by-step guide.
99
Total FAERS Reports
33 (33.3%)
Deaths Reported
36
Hospitalizations
99
As Primary/Secondary Suspect
27
Life-Threatening
26
Disabilities
Active Ingredient: ACETAMINOPHEN\PHENYLEPHRINE HYDROCHLORIDE ·
First Report: 2011 · Latest Report: 20241213
What Are the Most Common ACETAMINOPHEN\PHENYLEPHRINE Side Effects?
#1 Most Reported
Insomnia
26 reports (26.3%)
#2 Most Reported
Nausea
25 reports (25.3%)
#3 Most Reported
Joint swelling
24 reports (24.2%)
All ACETAMINOPHEN\PHENYLEPHRINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Insomnia | 26 | 26.3% | 13 | 14 |
| Nausea | 25 | 25.3% | 16 | 17 |
| Joint swelling | 24 | 24.2% | 16 | 17 |
| Headache | 23 | 23.2% | 15 | 17 |
| Mobility decreased | 21 | 21.2% | 16 | 13 |
| Hypersensitivity | 20 | 20.2% | 16 | 17 |
| Hypertension | 20 | 20.2% | 17 | 17 |
| Pemphigus | 20 | 20.2% | 13 | 14 |
| Abdominal discomfort | 19 | 19.2% | 15 | 15 |
| Arthralgia | 19 | 19.2% | 15 | 15 |
| Confusional state | 19 | 19.2% | 16 | 14 |
| Dyspnoea | 19 | 19.2% | 14 | 14 |
| General physical health deterioration | 19 | 19.2% | 18 | 13 |
| Glossodynia | 19 | 19.2% | 16 | 15 |
| Hand deformity | 19 | 19.2% | 16 | 15 |
| Hepatic enzyme increased | 19 | 19.2% | 16 | 15 |
| Infusion related reaction | 19 | 19.2% | 14 | 16 |
| Pyrexia | 19 | 19.2% | 11 | 15 |
| Dyspepsia | 18 | 18.2% | 10 | 11 |
| Fatigue | 18 | 18.2% | 15 | 15 |
Who Reports ACETAMINOPHEN\PHENYLEPHRINE Side Effects? Age & Gender Data
Gender: 90.8% female, 9.2% male. Average age: 42.0 years. Most reports from: CA. View detailed demographics →
Is ACETAMINOPHEN\PHENYLEPHRINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2011 | 1 | 0 | 0 |
| 2013 | 3 | 3 | 0 |
| 2014 | 2 | 0 | 1 |
| 2015 | 7 | 0 | 2 |
| 2016 | 3 | 0 | 0 |
| 2017 | 2 | 0 | 1 |
| 2018 | 4 | 0 | 0 |
| 2019 | 2 | 0 | 0 |
| 2020 | 1 | 0 | 0 |
| 2022 | 2 | 0 | 1 |
| 2023 | 1 | 0 | 0 |
| 2024 | 4 | 0 | 1 |
What Is ACETAMINOPHEN\PHENYLEPHRINE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 30 |
| Rheumatoid arthritis | 23 |
| Pain | 8 |
| Nasal congestion | 5 |
| Off label use | 5 |
| Sinus congestion | 5 |
Official FDA Label for ACETAMINOPHEN\PHENYLEPHRINE
Official prescribing information from the FDA-approved drug label.