Propoxyphene Side Effects
Applies to propoxyphene: oral capsule, oral tablet
In general, the adverse effects of propoxyphene may be more likely and more severe in patients with renal and/or liver disease.
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.[Ref]
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.[Ref]
Some of the cardiotoxic effects reported in association with propoxyphene may be attributable to its major active metabolite, norpropoxyphene.[Ref]
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.[Ref]
Genitourinary side effects including a case of retroperitoneal fibrosis have been reported.[Ref]
Dermatologic side effects including rashes and itch have been reported.[Ref]
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).[Ref]
Hematologic side effects have rarely included cases of hemolytic anemia, pancytopenia, and disseminated intravascular coagulation after administration (or abuse) of propoxyphene-containing compounds.[Ref]
Local side effects have included inadvertent intra-arterial injection with ensuing vascular compromise and distal necrosis has been reported in propoxyphene-abusing patients.[Ref]
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.[Ref]
Ocular side effects including eye swelling and vision blurred have been reported.
Hypersensitivity side effects have been reported.[Ref]
Psychiatric side effects including abnormal behavior, confusional state, hallucinations, and mental status change have been reported.
Respiratory side effects including dyspnea have been reported.
1. "Multum Information Services, Inc. Expert Review Panel"
2. Hedenmalm K "A case of severe withdrawal syndrome due to dextropropoxyphene." Ann Intern Med 123 (1995): 473
3. Rosenow EC 3d "The spectrum of drug-induced pulmonary disease." Ann Intern Med 77 (1972): 977-91
4. Shorr RI, Griffin MR, Daugherty JR, Ray WA "Opioid analgesics and the risk of hip fracture in the elderly: codeine and propoxyphene." J Gerontol 47 (1992): M111-5
5. Critchley J, Illingworth RN, Pottage A, Proudfoot AT, Prescott L "Acute poisoning with distalgesic." Br Med J 1 (1979): 342-3
6. "Product Information. Darvon (propoxyphene)." Lilly, Eli and Company, Indianapolis, IN.
7. Ng B, Alvear M "Dextropropoxyphene addiction--a drug of primary abuse." Am J Drug Alcohol Abuse 19 (1993): 153-8
8. Strode SW "Propoxyphene dependence and withdrawal." Am Fam Physician 32 (1985): 105-8
9. Harris B, Harper M "Psychosis after dextropropoxyphene." Lancet 2 (1979): 743
10. Claghorn JL, Schoolar JC "Propoxyphene hydrochloride, a drug of abuse." JAMA 196 (1966): 1089-91
11. Collins GB, Kiefer KS "Propoxyphene dependence: an update." Postgrad Med 70 (1981): 57-61
12. Wall R, Linford SM, Akhter MI "Addiction to Distalgesic (dextropropoxyphene)." Br Med J 280 (1980): 1213-4
13. Owen M, Hills LJ "How safe is dextropropoxyphene?." Med J Aust 1 (1980): 617-8
14. Whittington RM "Dextropropoxyphene addiction." Lancet 2 (1979): 743-4
15. Salguero CH, Villarreal JE, Hug CC Jr, Domino EF "Propoxyphene dependence." JAMA 210 (1969): 135-6
16. Briggs RS, Barrand KG, Levene M "Ischaemic colitis and drug abuse." Br Med J 2 (1977): 1478
17. Heaney RM "Left bundle branch block associated with propoxyphene hydrochloride poisoning." Ann Emerg Med 12 (1983): 780-2
18. Critchley JA, Smith MF, Prescott LF "Distalgesic abuse and retroperitoneal fibrosis." Br J Urol 57 (1985): 486-7
19. Almirall J, Montoliu J, Torras A, Revert L "Propoxyphene-induced hypoglycemia in a patient with chronic renal failure." Nephron 53 (1989): 273-5
20. Wiederholt IC, Genco M, Foley JM "Recurrent episodes of hypoglycemia induced by propoxyphene." Neurology 17 (1967): 703-6
21. Singer I, Forrest JN Jr "Drug-induced states of nephrogenic diabetes insipidus." Kidney Int 10 (1976): 82-95
22. Daikos GK, Kosmidis JC "Propoxyphene jaundice." JAMA 232 (1975): 835
23. Lee TH, Rees PJ "Hepatotoxicity of dextropropoxyphene." Br Med J 2 (1977): 296-7
24. Bassendine MF, Woodhouse KW, Bennett M, James OF "Dextropropoxyphene induced hepatotoxicity mimicking biliary tract disease." Gut 27 (1986): 444-9
25. Klein NC, Magida MG "Propoxyphene (Darvon) hepatotoxicity." Am J Dig Dis 16 (1971): 467-9
26. "Dextropropoxyphene." Med J Aust 2 (1979): 494
27. Ford MJ, Kellett RJ, Busuttil A, Finlayson ND "Dextropropoxyphene and jaundice." Br Med J 2 (1977): 674
28. Webster GK "Pancytopenia after administration of distalgesic." Br Med J 3 (1973): 353
29. Fulton JD, McGonigal G "Steroid responsive haemolytic anaemia due to dextropropoxyphene paracetamol combination." J R Soc Med 82 (1989): 228
30. Fisch HP, Wands J, Yeung J, Davis PJ "Pulmonary edema and disseminated intravascular coagulation after intravenous abuse of d-propoxyphene (darvon)." South Med J 65 (1972): 493-5
31. Pearlman HS, Wollowick BS, Alvarez EV "Intra-arterial injection of propoxyphene into brachial artery." JAMA 214 (1970): 2055-7
32. Dalakas MC "Subacute painful myopathy from chronic propoxyphene napsylate abuse." JAMA 255 (1986): 1709
33. Restrepo JF, Guzman R, Pena MA, Lizarazo H, Mendez O, Rondon F, Iglesias A "Fibrous myopathy induced by propoxyphene injections." J Rheumatol 20 (1993): 596-7
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.