ACETAMINOPHEN\PSEUDOEPHEDRINE\TRIPROLIDINE: 95 Adverse Event Reports & Safety Profile
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95
Total FAERS Reports
11 (11.6%)
Deaths Reported
48
Hospitalizations
95
As Primary/Secondary Suspect
12
Life-Threatening
10
Disabilities
Active Ingredient: ACETAMINOPHEN\PSEUDOEPHEDRINE HYDROCHLORIDE\TRIPROLIDINE HYDROCHLORIDE ·
First Report: 19950628 · Latest Report: 20240122
What Are the Most Common ACETAMINOPHEN\PSEUDOEPHEDRINE\TRIPROLIDINE Side Effects?
#1 Most Reported
Intentional self-injury
51 reports (53.7%)
#2 Most Reported
Intentional overdose
34 reports (35.8%)
#3 Most Reported
Drug abuse
31 reports (32.6%)
All ACETAMINOPHEN\PSEUDOEPHEDRINE\TRIPROLIDINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Intentional self-injury | 51 | 53.7% | 0 | 23 |
| Intentional overdose | 34 | 35.8% | 1 | 16 |
| Drug abuse | 31 | 32.6% | 0 | 17 |
| Vomiting | 24 | 25.3% | 7 | 20 |
| Nausea | 17 | 17.9% | 8 | 17 |
| Overdose | 12 | 12.6% | 0 | 12 |
| Headache | 10 | 10.5% | 8 | 9 |
| Suicide attempt | 10 | 10.5% | 0 | 10 |
| Hypertension | 9 | 9.5% | 9 | 9 |
| Tachycardia | 9 | 9.5% | 4 | 8 |
| Abdominal pain upper | 8 | 8.4% | 7 | 8 |
| Arthralgia | 8 | 8.4% | 8 | 8 |
| Confusional state | 8 | 8.4% | 8 | 8 |
| Dyspnoea | 8 | 8.4% | 7 | 7 |
| Hypersensitivity | 8 | 8.4% | 8 | 8 |
| Polyuria | 8 | 8.4% | 0 | 8 |
| Sluggishness | 8 | 8.4% | 0 | 4 |
| Sopor | 8 | 8.4% | 0 | 0 |
| Abdominal pain | 7 | 7.4% | 4 | 7 |
| Blister | 7 | 7.4% | 7 | 7 |
Who Reports ACETAMINOPHEN\PSEUDOEPHEDRINE\TRIPROLIDINE Side Effects? Age & Gender Data
Gender: 65.6% female, 34.4% male. Average age: 38.1 years. Most reports from: IT. View detailed demographics →
Is ACETAMINOPHEN\PSEUDOEPHEDRINE\TRIPROLIDINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2002 | 1 | 0 | 0 |
| 2005 | 1 | 0 | 0 |
| 2012 | 1 | 0 | 1 |
| 2013 | 1 | 0 | 0 |
| 2014 | 8 | 0 | 1 |
| 2015 | 2 | 0 | 1 |
| 2016 | 2 | 0 | 2 |
| 2017 | 18 | 0 | 16 |
| 2018 | 18 | 0 | 8 |
| 2019 | 3 | 0 | 0 |
| 2020 | 1 | 0 | 0 |
| 2021 | 1 | 0 | 1 |
| 2022 | 8 | 0 | 0 |
| 2023 | 1 | 0 | 0 |
| 2024 | 8 | 0 | 8 |
What Is ACETAMINOPHEN\PSEUDOEPHEDRINE\TRIPROLIDINE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 53 |
| Intentional self-injury | 11 |
| Drug abuse | 6 |
| Intentional overdose | 6 |
Official FDA Label for ACETAMINOPHEN\PSEUDOEPHEDRINE\TRIPROLIDINE
Official prescribing information from the FDA-approved drug label.