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Darvon Side Effects

Generic name: propoxyphene

Note: This document contains side effect information about propoxyphene. Some dosage forms listed on this page may not apply to the brand name Darvon.

Applies to propoxyphene: oral capsule, oral suspension, oral tablet.

Warning

Oral route (Capsule)

Do not prescribe propoxyphene for patients who are suicidal or addiction-prone. Prescribe propoxyphene with caution for patients taking tranquilizers or antidepressant drugs, and patients who use alcohol in excess. Patients should not exceed the recommended dose and alcohol intake should be limited. Propoxyphene products in excessive doses, either alone or in combination with other CNS depressants, including alcohol, are a major cause of drug-related deaths.

Oral route (Tablet)

Do not prescribe propoxyphene for patients who are suicidal or addiction-prone. Prescribe propoxyphene with caution for patients taking tranquilizers or antidepressant drugs, and patients who use alcohol in excess. Patients should not exceed the recommended dose and alcohol intake should be limited. Propoxyphene products in excessive doses, either alone or in combination with other CNS depressants, including alcohol, are a major cause of drug-related deaths.

Serious side effects of Darvon

Along with its needed effects, propoxyphene (the active ingredient contained in Darvon) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking propoxyphene:

Rare

Incidence not known

Get emergency help immediately if any of the following symptoms of overdose occur while taking propoxyphene:

Symptoms of overdose

Other side effects of Darvon

Some side effects of propoxyphene may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Incidence not known

For Healthcare Professionals

Applies to propoxyphene: oral capsule, oral tablet.

General

In general, the adverse effects of propoxyphene (the active ingredient contained in Darvon) 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.[Ref]

Nervous system

Nervous system side effects have included dizziness, sedation, stupor, delirium, somnolence, ataxia, coma, syncope, and respiratory depression. The sedative effects of propoxyphene (the active ingredient contained in Darvon) have been associated with a 60% increased risk of hip fracture in elderly patients.[Ref]

Other

Other side effects have included dependence (although the abuse liability of propoxyphene (the active ingredient contained in Darvon) 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]

Cardiovascular

Some of the cardiotoxic effects reported in association with propoxyphene (the active ingredient contained in Darvon) 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]

Gastrointestinal

A case of ischemic colitis has been reported following an overdose of propoxyphene (the active ingredient contained in Darvon) which was complicated by severe hypotension.[Ref]

Gastrointestinal side effects have included nausea, vomiting, and constipation which have been relatively common. Gastrointestinal bleeding and acute pancreatitis have also been reported.[Ref]

Genitourinary

Genitourinary side effects including a case of retroperitoneal fibrosis have been reported.[Ref]

Dermatologic

Dermatologic side effects including rashes and itch have been reported.[Ref]

Renal

Renal side effects have included a single case of nephrogenic diabetes insipidus following an overdose of propoxyphene (the active ingredient contained in Darvon) (however, other causes of diabetes insipidus in that patient were not rigorously excluded).[Ref]

Hepatic

Hepatic side effects have included elevated liver function tests, jaundice, hepatic steatosis, hepatomegaly, hepatocellular injury, and hepatotoxicity.[Ref]

Hematologic

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

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

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]

Metabolic

Metabolic side effects including metabolic acidosis have been reported. Cases of severe hypoglycemia have been reported in patients with chronic renal failure.[Ref]

Ocular

Ocular side effects including eye swelling and vision blurred have been reported.

Hypersensitivity

Hypersensitivity side effects have been reported.[Ref]

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.

References

1. Multum Information Services, Inc. Expert Review Panel

2. Rosenow EC 3d. The spectrum of drug-induced pulmonary disease. Ann Intern Med. 1972;77:977-91.

3. Shorr RI, Griffin MR, Daugherty JR, Ray WA. Opioid analgesics and the risk of hip fracture in the elderly: codeine and propoxyphene. J Gerontol. 1992;47:M111-5.

4. Ng B, Alvear M. Dextropropoxyphene addiction--a drug of primary abuse. Am J Drug Alcohol Abuse. 1993;19:153-8.

5. Critchley J, Illingworth RN, Pottage A, Proudfoot AT, Prescott L. Acute poisoning with distalgesic. Br Med J. 1979;1:342-3.

6. Product Information. Darvon (propoxyphene). Lilly, Eli and Company. 2001;PROD.

7. Hedenmalm K. A case of severe withdrawal syndrome due to dextropropoxyphene. Ann Intern Med. 1995;123:473.

8. Strode SW. Propoxyphene dependence and withdrawal. Am Fam Physician. 1985;32:105-8.

9. Wall R, Linford SM, Akhter MI. Addiction to Distalgesic (dextropropoxyphene). Br Med J. 1980;280:1213-4.

10. Salguero CH, Villarreal JE, Hug CC Jr, Domino EF. Propoxyphene dependence. JAMA. 1969;210:135-6.

11. Claghorn JL, Schoolar JC. Propoxyphene hydrochloride, a drug of abuse. JAMA. 1966;196:1089-91.

12. Whittington RM. Dextropropoxyphene addiction. Lancet. 1979;2:743-4.

13. Harris B, Harper M. Psychosis after dextropropoxyphene. Lancet. 1979;2:743.

14. Owen M, Hills LJ. How safe is dextropropoxyphene?. Med J Aust. 1980;1:617-8.

15. Collins GB, Kiefer KS. Propoxyphene dependence: an update. Postgrad Med. 1981;70:57-61.

16. Heaney RM. Left bundle branch block associated with propoxyphene hydrochloride poisoning. Ann Emerg Med. 1983;12:780-2.

17. Briggs RS, Barrand KG, Levene M. Ischaemic colitis and drug abuse. Br Med J. 1977;2:1478.

18. Critchley JA, Smith MF, Prescott LF. Distalgesic abuse and retroperitoneal fibrosis. Br J Urol. 1985;57:486-7.

19. Wiederholt IC, Genco M, Foley JM. Recurrent episodes of hypoglycemia induced by propoxyphene. Neurology. 1967;17:703-6.

20. Singer I, Forrest JN Jr. Drug-induced states of nephrogenic diabetes insipidus. Kidney Int. 1976;10:82-95.

21. Almirall J, Montoliu J, Torras A, Revert L. Propoxyphene-induced hypoglycemia in a patient with chronic renal failure. Nephron. 1989;53:273-5.

22. Klein NC, Magida MG. Propoxyphene (Darvon) hepatotoxicity. Am J Dig Dis. 1971;16:467-9.

23. Ford MJ, Kellett RJ, Busuttil A, Finlayson ND. Dextropropoxyphene and jaundice. Br Med J. 1977;2:674.

24. Lee TH, Rees PJ. Hepatotoxicity of dextropropoxyphene. Br Med J. 1977;2:296-7.

25. Bassendine MF, Woodhouse KW, Bennett M, James OF. Dextropropoxyphene induced hepatotoxicity mimicking biliary tract disease. Gut. 1986;27:444-9.

26. Daikos GK, Kosmidis JC. Propoxyphene jaundice. JAMA. 1975;232:835.

27. Dextropropoxyphene. Med J Aust. 1979;2:494.

28. Webster GK. Pancytopenia after administration of distalgesic. Br Med J. 1973;3:353.

29. Fulton JD, McGonigal G. Steroid responsive haemolytic anaemia due to dextropropoxyphene paracetamol combination. J R Soc Med. 1989;82:228.

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. 1972;65:493-5.

31. Pearlman HS, Wollowick BS, Alvarez EV. Intra-arterial injection of propoxyphene into brachial artery. JAMA. 1970;214:2055-7.

32. Dalakas MC. Subacute painful myopathy from chronic propoxyphene napsylate abuse. JAMA. 1986;255:1709.

33. Restrepo JF, Guzman R, Pena MA, Lizarazo H, Mendez O, Rondon F, Iglesias A. Fibrous myopathy induced by propoxyphene injections. J Rheumatol. 1993;20:596-7.

Further information

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.