Propoxyphene Side Effects
Brand Names: Darvon, Darvon-N
Please note - some side effects for Propoxyphene may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Side Effects of Propoxyphene - for the Consumer
Propoxyphene
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Propoxyphene:
Seek medical attention right away if any of these SEVERE side effects occur when using Propoxyphene:Constipation; dizziness; drowsiness; lightheadedness; nausea; vomiting.
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); anxiety; cold or clammy skin; confusion; excessive sweating; hallucinations; loss of appetite; loss of consciousness; mental or mood changes; seizures; severe drowsiness or dizziness; severe or persistent stomach pain; vision changes; weakness; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
TopSide Effects by Body System - for Healthcare Professionals
General
In general, the adverse effects of propoxyphene may be more likely and more severe in patients with renal and/or liver disease.
General side effects including drug tolerance and influenza type illness have been reported.
Nervous system
Nervous system side effects have included dizziness, sedation, stupor, delirium, somnolence, ataxia, coma, syncope, and respiratory depression. The sedative effects of propoxyphene have been associated with a 60% increased risk of hip fracture in elderly patients.
Other
Other side effects have included dependence (although the abuse liability of propoxyphene is less than that of some other narcotic analgesics). Withdrawal symptoms after either abrupt cessation or fast tapering may occur and include agitation, restlessness, anxiety, insomnia, tremor, tachycardia, hallucinations, psychosis, abdominal cramps, vomiting, sweating, and seizures.
Drug toxicity, multiple drug overdose, and narcotic overdose have also been reported.
Sensorineural deafness has been reported following chronic abuse and/or large doses of propoxyphene-containing compounds. Optic atrophy has been reported following overdose.
Cardiovascular
Cardiovascular side effects have included arrhythmia, bradycardia, cardiac/respiratory arrest, congestive arrest, congestive heart failure (CHF), tachycardia, myocardial infarction (MI), hypotension, decreased blood pressure, elevated heart rate, abnormal heart rate, and dizziness. A variety of arrhythmias (including heart block) have been reported most often in association with propoxyphene overdose.
Some of the cardiotoxic effects reported in association with propoxyphene may be attributable to its major active metabolite, norpropoxyphene.
Gastrointestinal
Gastrointestinal side effects have included nausea, vomiting, and constipation which have been relatively common. Gastrointestinal bleeding and acute pancreatitis have also been reported.
A case of ischemic colitis has been reported following an overdose of propoxyphene which was complicated by severe hypotension.
Genitourinary
Genitourinary side effects including a case of retroperitoneal fibrosis have been reported.
Dermatologic
Dermatologic side effects including rashes and itch have been reported.
Renal
Renal side effects have included a single case of nephrogenic diabetes insipidus following an overdose of propoxyphene (however, other causes of diabetes insipidus in that patient were not rigorously excluded).
Hepatic
Hepatic side effects have included elevated liver function tests, jaundice, hepatic steatosis, hepatomegaly, hepatocellular injury, and hepatotoxicity.
Hematologic
Hematologic side effects have rarely included cases of hemolytic anemia, pancytopenia, and disseminated intravascular coagulation after administration (or abuse) of propoxyphene-containing compounds.
Local
Local side effects have included inadvertent intra-arterial injection with ensuing vascular compromise and distal necrosis has been reported in propoxyphene-abusing patients.
Musculoskeletal
Musculoskeletal side effects including myopathy and rhabdomyolysis have been reported after chronic oral use. Fibrous myopathy has also been reported in propoxyphene-abusing patients who administered the drug via intramuscular injection.
Metabolic
Metabolic side effects including metabolic acidosis have been reported. Cases of severe hypoglycemia have been reported in patients with chronic renal failure.
Ocular
Ocular side effects including eye swelling and vision blurred have been reported.
Hypersensitivity
Hypersensitivity side effects have been reported.
Psychiatric
Psychiatric side effects including abnormal behavior, confusional state, hallucinations, and mental status change have been reported.
Respiratory
Respiratory side effects including dyspnea have been reported.
TopMore Propoxyphene resources
- Propoxyphene Professional Patient Advice (Wolters Kluwer)
- Propoxyphene MedFacts Consumer Leaflet (Wolters Kluwer)
- propoxyphene Concise Consumer Information (Cerner Multum)
- propoxyphene Advanced Consumer (Micromedex) - Includes Dosage Information
- Darvon Prescribing Information (FDA)
- Darvon-N Prescribing Information (FDA)
- Propoxyphene Hydrochloride Monograph (AHFS DI)
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