PROPOXYPHENE: 4,444 Adverse Event Reports & Safety Profile
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4,444
Total FAERS Reports
402 (9.0%)
Deaths Reported
156
Hospitalizations
4,444
As Primary/Secondary Suspect
9
Life-Threatening
417
Disabilities
Approved Prior to Jan 1, 1982
FDA Approved
Discontinued
Status
Yes
Generic Available
Active Ingredient: PROPOXYPHENE HYDROCHLORIDE · FDA Application: 010997 ·
First Report: 19790101 · Latest Report: 20230814
What Are the Most Common PROPOXYPHENE Side Effects?
#1 Most Reported
Dependence
3,206 reports (72.1%)
#2 Most Reported
Overdose
585 reports (13.2%)
#3 Most Reported
Back pain
424 reports (9.5%)
All PROPOXYPHENE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Dependence | 3,206 | 72.1% | 123 | 7 |
| Overdose | 585 | 13.2% | 130 | 25 |
| Back pain | 424 | 9.5% | 2 | 0 |
| Cardiovascular disorder | 399 | 9.0% | 40 | 1 |
| Movement disorder | 399 | 9.0% | 39 | 2 |
| Nervous system disorder | 399 | 9.0% | 40 | 1 |
| Drug hypersensitivity | 337 | 7.6% | 0 | 5 |
| Pain | 244 | 5.5% | 3 | 64 |
| Back injury | 239 | 5.4% | 0 | 2 |
| Death | 214 | 4.8% | 212 | 10 |
| Toxicity to various agents | 142 | 3.2% | 127 | 31 |
| Arthralgia | 122 | 2.8% | 3 | 0 |
| Nausea | 103 | 2.3% | 2 | 66 |
| Headache | 95 | 2.1% | 2 | 64 |
| Road traffic accident | 94 | 2.1% | 4 | 6 |
| Drug ineffective | 81 | 1.8% | 4 | 69 |
| Off label use | 78 | 1.8% | 11 | 72 |
| Spinal operation | 75 | 1.7% | 0 | 0 |
| Constipation | 73 | 1.6% | 2 | 61 |
| Malaise | 70 | 1.6% | 0 | 65 |
Who Reports PROPOXYPHENE Side Effects? Age & Gender Data
Gender: 53.2% female, 46.8% male. Average age: 58.2 years. Most reports from: US. View detailed demographics →
Is PROPOXYPHENE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2002 | 2 | 1 | 0 |
| 2003 | 2 | 0 | 1 |
| 2004 | 2 | 2 | 1 |
| 2005 | 3 | 2 | 1 |
| 2006 | 5 | 2 | 3 |
| 2007 | 5 | 2 | 1 |
| 2008 | 4 | 1 | 1 |
| 2009 | 2 | 2 | 0 |
| 2010 | 6 | 4 | 5 |
| 2011 | 2 | 0 | 0 |
| 2012 | 15 | 13 | 0 |
| 2013 | 4 | 1 | 0 |
| 2014 | 2 | 0 | 1 |
| 2015 | 3 | 3 | 0 |
| 2016 | 3 | 1 | 1 |
| 2017 | 9 | 1 | 1 |
| 2018 | 7 | 0 | 5 |
| 2019 | 6 | 5 | 0 |
| 2021 | 1 | 0 | 0 |
| 2022 | 2 | 0 | 1 |
| 2023 | 3 | 1 | 0 |
What Is PROPOXYPHENE Used For?
| Indication | Reports |
|---|---|
| Pain | 421 |
| Product used for unknown indication | 409 |
| Dysmenorrhoea | 9 |
| Suicide attempt | 8 |
| Nasal septal operation | 5 |
| Sunct syndrome | 5 |
PROPOXYPHENE vs Alternatives: Which Is Safer?
PROPOXYPHENE vs PROPOXYPHENE/ACETAMINOPHEN
PROPOXYPHENE vs PROPRANOLOL
PROPOXYPHENE vs PROPRANOLOL\PROPRANOLOL
PROPOXYPHENE vs PROPYLENE GLYCOL
PROPOXYPHENE vs PROPYLTHIOURACIL
PROPOXYPHENE vs PROTAMINE
PROPOXYPHENE vs PROTHIPENDYL
PROPOXYPHENE vs PROTIONAMIDE
PROPOXYPHENE vs PROTONIX
PROPOXYPHENE vs PROTOPIC
Official FDA Label for PROPOXYPHENE
Official prescribing information from the FDA-approved drug label.