OPIUM: 171 Adverse Event Reports & Safety Profile
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171
Total FAERS Reports
20 (11.7%)
Deaths Reported
87
Hospitalizations
171
As Primary/Secondary Suspect
20
Life-Threatening
2
Disabilities
First Report: 1991 · Latest Report: 20250307
What Are the Most Common OPIUM Side Effects?
#1 Most Reported
Drug dependence
32 reports (18.7%)
#2 Most Reported
Toxicity to various agents
25 reports (14.6%)
#3 Most Reported
Drug ineffective
22 reports (12.9%)
All OPIUM Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug dependence | 32 | 18.7% | 0 | 5 |
| Toxicity to various agents | 25 | 14.6% | 2 | 4 |
| Drug ineffective | 22 | 12.9% | 5 | 16 |
| Drug abuse | 21 | 12.3% | 0 | 9 |
| Pyrexia | 21 | 12.3% | 4 | 20 |
| Abdominal pain | 19 | 11.1% | 1 | 1 |
| Decreased appetite | 19 | 11.1% | 0 | 2 |
| Dizziness | 19 | 11.1% | 0 | 19 |
| Asthma | 18 | 10.5% | 0 | 18 |
| Dyspnoea | 18 | 10.5% | 0 | 18 |
| Substance use disorder | 18 | 10.5% | 0 | 8 |
| Acute kidney injury | 17 | 9.9% | 1 | 17 |
| Anaemia | 17 | 9.9% | 0 | 0 |
| Chronic kidney disease | 17 | 9.9% | 0 | 17 |
| Irritability | 17 | 9.9% | 0 | 4 |
| Renal cyst | 17 | 9.9% | 0 | 17 |
| Arterial thrombosis | 16 | 9.4% | 0 | 16 |
| Arteriosclerosis | 16 | 9.4% | 0 | 16 |
| Cardiac failure | 16 | 9.4% | 0 | 16 |
| Congenital coronary artery malformation | 16 | 9.4% | 0 | 16 |
Who Reports OPIUM Side Effects? Age & Gender Data
Gender: 46.4% female, 53.6% male. Average age: 54.7 years. Most reports from: US. View detailed demographics →
Is OPIUM Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2001 | 1 | 0 | 0 |
| 2003 | 1 | 0 | 1 |
| 2010 | 15 | 0 | 15 |
| 2012 | 2 | 0 | 1 |
| 2013 | 2 | 0 | 1 |
| 2014 | 1 | 0 | 1 |
| 2015 | 2 | 0 | 0 |
| 2017 | 5 | 0 | 1 |
| 2018 | 4 | 1 | 4 |
| 2019 | 3 | 0 | 1 |
| 2020 | 1 | 1 | 0 |
| 2021 | 2 | 0 | 1 |
| 2022 | 4 | 0 | 3 |
| 2023 | 9 | 0 | 7 |
| 2024 | 4 | 0 | 4 |
| 2025 | 13 | 0 | 7 |
What Is OPIUM Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 84 |
| Diarrhoea | 21 |
| Pain | 8 |
| Drug dependence | 5 |
OPIUM vs Alternatives: Which Is Safer?
OPIUM vs OPSUMIT
OPIUM vs OPTIMARK
OPIUM vs OPTIRAY
OPIUM vs ORELABRUTINIB
OPIUM vs ORENCIA
OPIUM vs ORITAVANCIN
OPIUM vs ORITAVANCIN DIPHOSPHATE
OPIUM vs ORLISTAT
OPIUM vs ORNIDAZOLE
OPIUM vs ORPHENADRINE
Official FDA Label for OPIUM
Official prescribing information from the FDA-approved drug label.