ACETAMINOPHEN\ORPHENADRINE: 59 Adverse Event Reports & Safety Profile
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59
Total FAERS Reports
2 (3.4%)
Deaths Reported
15
Hospitalizations
59
As Primary/Secondary Suspect
2
Life-Threatening
2
Disabilities
Active Ingredient: ACETAMINOPHEN\ORPHENADRINE CITRATE ·
First Report: 19850101 · Latest Report: 20250827
What Are the Most Common ACETAMINOPHEN\ORPHENADRINE Side Effects?
#1 Most Reported
Drug dependence
16 reports (27.1%)
#2 Most Reported
Overdose
12 reports (20.3%)
#3 Most Reported
Somnolence
10 reports (16.9%)
All ACETAMINOPHEN\ORPHENADRINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug dependence | 16 | 27.1% | 2 | 2 |
| Overdose | 12 | 20.3% | 2 | 2 |
| Somnolence | 10 | 17.0% | 0 | 5 |
| Asthma | 7 | 11.9% | 0 | 0 |
| Dependence | 7 | 11.9% | 0 | 0 |
| Hypokalaemia | 7 | 11.9% | 0 | 7 |
| Hypoacusis | 6 | 10.2% | 0 | 0 |
| Osteoporosis | 6 | 10.2% | 0 | 0 |
| Skin cancer | 6 | 10.2% | 0 | 0 |
| Back injury | 5 | 8.5% | 0 | 0 |
| Choking | 5 | 8.5% | 0 | 0 |
| Delusion | 5 | 8.5% | 0 | 0 |
| Fall | 5 | 8.5% | 0 | 0 |
| Hyperhidrosis | 5 | 8.5% | 0 | 0 |
| Hypopnoea | 5 | 8.5% | 0 | 0 |
| Intentional overdose | 5 | 8.5% | 0 | 5 |
| Learning disability | 5 | 8.5% | 0 | 0 |
| Metabolic acidosis | 5 | 8.5% | 0 | 5 |
| Myocardial infarction | 5 | 8.5% | 0 | 0 |
| Somnambulism | 5 | 8.5% | 0 | 0 |
Who Reports ACETAMINOPHEN\ORPHENADRINE Side Effects? Age & Gender Data
Gender: 54.7% female, 45.3% male. Average age: 49.8 years. Most reports from: CA. View detailed demographics →
Is ACETAMINOPHEN\ORPHENADRINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2007 | 1 | 0 | 1 |
| 2011 | 1 | 0 | 1 |
| 2015 | 3 | 0 | 0 |
| 2017 | 2 | 0 | 0 |
| 2018 | 1 | 1 | 0 |
| 2021 | 1 | 0 | 1 |
| 2022 | 4 | 0 | 1 |
| 2023 | 3 | 0 | 1 |
| 2024 | 1 | 0 | 1 |
| 2025 | 1 | 0 | 0 |
What Is ACETAMINOPHEN\ORPHENADRINE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 44 |
Official FDA Label for ACETAMINOPHEN\ORPHENADRINE
Official prescribing information from the FDA-approved drug label.