Product name as reported
Propoxyphene Hydrochloride/Acetaminophen 65/650: adverse event reports filed with FDA
1,077 reports list it as a suspect or interacting product, 2008–2013.
- 1,077
- reports as suspect product
- 0% of all reports · about 59 a year
- 0
- reports, 12 months to June 2026
- 0 in the 12 months before
- 100%
- marked serious by the reporter
- 57.4% across all reports
- 7.5%
- record death among outcomes, as reported
- 81 reports · not verified by FDA
1,077 adverse event reports received by FDA list the product name "Propoxyphene Hydrochloride/Acetaminophen 65/650" as reporters wrote it as a suspect or interacting product, from February 2008 to April 2013. A further 0 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 59 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 cardiac disorder (93.3%), arrhythmia (5.1%) and cardiovascular disorder (5%). A report can list several reactions, so shares add to more than 100%; 29 different terms appear across these reports. Cardiac disorder is recorded in 93.3% of these reports, against 0.4% of all reports in the database.
100% of the reports are marked serious by the reporter; 7.5% record death among the outcomes and 0% record hospitalisation, as reported. 99.2% of the reports came from consumers, and the largest patient age group is 18 to 44 (0.6%). 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 Hydrochloride/Acetaminophen 65/650 was received in the five years to June 2026; the latest was received in April 2013.
By year received
Reactions recorded in the reports
share of Propoxyphene Hydrochloride/Acetaminophen 65/650 reports recording the termall reports in the database
- Cardiac disorder93.3%1,005
- Arrhythmia5.1%55
- Myocardial infarctionheart attack2.5%27
- Tachycardiafast heart rate1.8%19
- Bradycardiaslow heart rate1.6%17
- Heart rate irregular1.4%15
- Electrocardiogram QT prolongeda QT prolongation on the ECG0.7%8
- Atrial fibrillationan irregular heart rhythm0.6%7
- Cardiac arrestthe heart stopped0.6%7
- Syncopefainting0.6%7
- Ventricular fibrillationa chaotic rhythm from the lower heart chambers0.4%4
- Bundle branch block0.3%3
- Bundle branch block right0.2%2
- Cardiac failure congestivecongestive heart failure0.2%2
- Cardiomyopathydisease of the heart muscle0.2%2
- Coronary arterial stent insertion0.2%2
- Injurya physical injury0.2%2
- Ventricular tachycardiaa fast rhythm from the lower heart chambers0.2%2
- Aortic valve disease0.1%1
- Atrial flutter0.1%1
- Atrial tachycardia0.1%1
- Bundle branch block left0.1%1
- Cardio-respiratory arrestthe heart and breathing stopped0.1%1
- Deaththe patient died; cause not stated by this term0.1%1
Top 29 of 29 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
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
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 100% 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 management | 878 | 81.5% |
| Pain | 150 | 13.9% |
| Analgesia | 40 | 3.7% |
The indication field is filled in by the reporter and is often blank; shares are of all 1,077 reports.
In context
| Measure | Propoxyphene Hydrochloride/Acetaminophen 65/650 | All reports |
|---|---|---|
| Reports as suspect product | 1,077 | 20,646,523 |
| Share of that pool | — | 0% |
| Reports, latest 12 months | 0 | 1,332,454 |
| Marked serious | 100% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 75 | 91 |
| Hospitalisation recorded, per 1,000 reports | 0 | 213 |
| Consumer-filed share | 99.2% | 45.8% |
| Top term, share of reports | Cardiac disorder 93.3% | 0.4% |
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 Hydrochloride/Acetaminophen 65/650 reports
How many adverse event reports has FDA received for Propoxyphene Hydrochloride/Acetaminophen 65/650?
1,077 reports list Propoxyphene Hydrochloride/Acetaminophen 65/650 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 0 list it only as a concomitant medication.
What reactions are recorded in Propoxyphene Hydrochloride/Acetaminophen 65/650 reports?
cardiac disorder (93.3%), arrhythmia (5.1%), cardiovascular disorder (5%), myocardial infarction (2.5%) and tachycardia (1.8%). 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 Hydrochloride/Acetaminophen 65/650 was responsible.
How serious are the reports?
100% are marked serious by the reporter. Among the outcomes recorded, 7.5% of reports include death and 0% 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?
consumer or non-health professional (99.2%), physician (0.5%) and pharmacist (0.4%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Propoxyphene Hydrochloride/Acetaminophen 65/650 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 Hydrochloride/Acetaminophen 65/650 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 Hydrochloride/Acetaminophen 65/650?
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 Hydrochloride/Acetaminophen 65/650 as a suspect or interacting product; reports listing it only as a concomitant medication (0) 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.