Product name as reported

Propoxyphene Hcl: adverse event reports filed with FDA

452 reports list it as a suspect or interacting product, 2004–2019.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

452
reports as suspect product: 0% of all reports · about 20 a year; 0
reports, 12 months to June 2026: 0 in the 12 months before; 95.8%
marked serious by the reporter: 57.4% across all reports; 27.7%
record death among outcomes, as reported: 125 reports · not verified by FDA

452 adverse event reports received by FDA list the product name "Propoxyphene Hcl" as reporters wrote it as a suspect or interacting product, from January 2004 to July 2019. A further 177 reports list it only as a concomitant medication, and those are not counted in the figures on this page.

In the 12 months to June 2026, 0 reports listed it, and none in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 20 reports a year and 0% of the 20,646,523 reports in the database. How many people take it is not in the data, so a count is not a rate of occurrence.

The reactions recorded most often are cardio-respiratory arrest (65.5%), arrhythmia (64.6%) and myocardial infarction (64.2%). A report can list several reactions, so shares add to more than 100%; 75 different terms appear across these reports. Cardio-respiratory arrest is recorded in 65.5% of these reports, against 0.2% of all reports in the database.

95.8% of the reports are marked serious by the reporter; 27.7% record death among the outcomes and 66.2% record hospitalisation, as reported. 66.8% of the reports came from other health professionals, and the largest patient age group is 18 to 44 (14.8%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

Reports by month, five years

No report listing Propoxyphene Hcl was received in the five years to June 2026; the latest was received in July 2019.

By year received

Reactions recorded in the reports

share of Propoxyphene Hcl reports recording the termall reports in the database

Cardio-respiratory arrestthe heart and breathing stopped65.5%296
Arrhythmia64.6%292
Myocardial infarctionheart attack64.2%290
Cardiovascular disorder63.9%289
Cardiac disorder63.5%287
Sudden cardiac deatha sudden death from the heart63.1%285
Drug toxicity6%27
Completed suicidedeath by suicide5.3%24
Deaththe patient died; cause not stated by this term4.6%21
Multiple drug overdose3.8%17
Painpain, site not specified3.8%17
Anhedonia3.5%16
Emotional distressemotional distress3.3%15
Economic problema financial problem3.1%14
Deformity2.9%13
Fear of death2.9%13
Family stress2.7%12
Cardiac arrestthe heart stopped2.2%10
Pulmonary oedemafluid in the lungs2.2%10
Accidental overdosean accidental overdose2%9
Overdosea dose above the recommended amount2%9
General physical health deteriorationgeneral decline in health1.8%8
Poisoning1.8%8
Respiratory arrestbreathing stopped1.8%8
Movement disorder1.5%7
Nervous system disorder1.5%7
Drug abusemisuse of a medicine1.3%6
Mental disorder1.3%6
Accidental death1.1%5
Drug abuser1.1%5

Top 30 of 75 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the share of all reports in the database; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Death27.7%125

Life-threatening0.9%4

Hospitalisation (initial or prolonged)66.2%299

Disability65.7%297

Congenital anomaly0.4%2

Other serious70.8%320

Not serious4.2%19

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 20,646,523 reports. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Patient age

Under 20%0

2 to 110%0

12 to 170.2%1

18 to 4414.8%67

45 to 648.6%39

65 to 740.9%4

75 and over1.3%6

Age not given74.1%335

Patient sex

Female60.8%275

Male35.2%159

Not given4%18

Who reported

Physician15.3%69

Pharmacist1.3%6

Other health professional6.9%31

Lawyer66.8%302

Consumer or non-health professional3.5%16

Not given6.2%28

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 90.5% of reports give the United States as the country of the event or reporter.

Reason for use recorded

Indication as recorded (MedDRA)	Reports	Share
Pain	209	46.2%
Intentional drug misuse	2	0.4%
Osteoarthritis	2	0.4%

The indication field is filled in by the reporter and is often blank; shares are of all 452 reports.

In context

Measure	Propoxyphene Hcl	All reports
Reports as suspect product	452	20,646,523
Share of that pool	—	0%
Reports, latest 12 months	0	1,332,454
Marked serious	95.8%	57.4%
Death recorded among outcomes, per 1,000 reports	277	91
Hospitalisation recorded, per 1,000 reports	662	213
Consumer-filed share	3.5%	45.8%
Top term, share of reports	Cardio-respiratory arrest 65.5%	0.2%

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Questions about Propoxyphene Hcl reports

How many adverse event reports has FDA received for Propoxyphene Hcl?

452 reports list Propoxyphene Hcl as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 0 of them arrived in the latest 12 months. Another 177 list it only as a concomitant medication.

What reactions are recorded in Propoxyphene Hcl reports?

cardio-respiratory arrest (65.5%), arrhythmia (64.6%), myocardial infarction (64.2%), cardiovascular disorder (63.9%) and cardiac disorder (63.5%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Propoxyphene Hcl was responsible.

How serious are the reports?

95.8% are marked serious by the reporter. Among the outcomes recorded, 27.7% of reports include death and 66.2% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.

Who files these reports?

lawyer (66.8%), physician (15.3%) and other health professional (6.9%). Most reports reach FDA through the manufacturer, which must forward reports it receives.

Are reports for Propoxyphene Hcl rising?

0 reports in the 12 months to June 2026, and none in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.

Do these reports show that Propoxyphene Hcl was responsible for these reactions?

No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.

Is this a list of the side effects of Propoxyphene Hcl?

No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.

How do I report an adverse event?

Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Propoxyphene Hcl as a suspect or interacting product; reports listing it only as a concomitant medication (177) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.