Darvon-N Side Effects

Generic Name: propoxyphene

Note: This page contains information about the side effects of propoxyphene. Some of the dosage forms included on this document may not apply to the brand name Darvon-N.

Not all side effects for Darvon-N may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

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

In addition to its needed effects, some unwanted effects may be caused by propoxyphene (the active ingredient contained in Darvon-N). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking propoxyphene:

Rare
  • Abdominal or stomach pain
  • chills
  • clay-colored stools
  • dark urine
  • dizziness
  • fever
  • headache
  • itching
  • loss of appetite
  • nausea
  • rash
  • unpleasant breath odor
  • unusual tiredness or weakness
  • vomiting of blood
  • yellow eyes or skin
Incidence not known
  • Bloating
  • bloody or black, tarry stools
  • bloody or cloudy urine
  • change in consciousness
  • chest pain or discomfort
  • confusion
  • constipation
  • darkened urine
  • decreased urine output
  • difficult or troubled breathing
  • dilated neck veins
  • drowsiness
  • extreme fatigue
  • fainting
  • fast, slow, pounding, or irregular heartbeat or pulse
  • fever with or without chills
  • hives
  • hoarseness
  • indigestion
  • irregular, fast or slow, or shallow breathing
  • irritation
  • itching
  • joint pain, stiffness, or swelling
  • light-colored stools
  • loss of consciousness
  • muscle tremors
  • no blood pressure or pulse
  • no breathing
  • pain or discomfort in the arms, jaw, back, or neck
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pale or blue lips, fingernails, or skin
  • rapid, deep breathing
  • redness of the skin
  • restlessness
  • right upper abdominal or stomach pain and fullness
  • severe stomach pain
  • shakiness and unsteady walk
  • shortness of breath
  • stomach cramps
  • stopping of the heart
  • sudden decrease in the amount of urine
  • swelling of the eyelids, face, fingers, lips, hands, lower legs, or feet
  • thoughts of suicide
  • tightness in the chest
  • troubled breathing or swallowing
  • unconsciousness
  • unsteadiness, trembling, or other problems with muscle control or coordination
  • vomiting of blood or material that looks like coffee grounds
  • weight gain
  • wheezing

If any of the following symptoms of overdose occur while taking propoxyphene, get emergency help immediately:

Symptoms of overdose
  • Bluish color of the fingernails, lips, skin, palms, or nail beds
  • convulsion
  • coughing that sometimes produces a pink frothy sputum
  • decreased awareness or responsiveness
  • difficult, fast, or noisy breathing, sometimes with wheezing
  • dilated pupils
  • muscle tremors
  • pale skin
  • pounding or rapid pulse
  • rapid, deep breathing
  • severe sleepiness
  • sleepiness or unusual drowsiness
  • slow to respond
  • slurred speech
  • weight loss

Some of the side effects that can occur with propoxyphene may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Relaxed and calm
Incidence not known
  • Abnormal behavior
  • blurred or loss of vision
  • diarrhea
  • disturbed color perception
  • double vision
  • false or unusual sense of well-being
  • halos around lights
  • mental depression or anxiety
  • muscular pain, tenderness, wasting, or weakness
  • night blindness
  • nightmares or unusually vivid dreams
  • overbright appearance of lights
  • seeing, hearing, or feeling things that are not there
  • swelling of the eye
  • tunnel vision

For Healthcare Professionals

Applies to propoxyphene: oral capsule, oral tablet

General

In general, the adverse effects of propoxyphene (the active ingredient contained in Darvon-N) 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-N) 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-N) 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-N) 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

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

A case of ischemic colitis has been reported following an overdose of propoxyphene which was complicated by severe hypotension.[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-N) (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. Hedenmalm K "A case of severe withdrawal syndrome due to dextropropoxyphene." Ann Intern Med 123 (1995): 473

3. "Product Information. Darvon (propoxyphene)." Lilly, Eli and Company, Indianapolis, IN.

4. Rosenow EC 3d "The spectrum of drug-induced pulmonary disease." Ann Intern Med 77 (1972): 977-91

5. 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

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

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

12. Collins GB, Kiefer KS "Propoxyphene dependence: an update." Postgrad Med 70 (1981): 57-61

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

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

15. Whittington RM "Dextropropoxyphene addiction." Lancet 2 (1979): 743-4

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

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

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

23. Daikos GK, Kosmidis JC "Propoxyphene jaundice." JAMA 232 (1975): 835

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

25. "Dextropropoxyphene." Med J Aust 2 (1979): 494

26. Ford MJ, Kellett RJ, Busuttil A, Finlayson ND "Dextropropoxyphene and jaundice." Br Med J 2 (1977): 674

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

28. Fulton JD, McGonigal G "Steroid responsive haemolytic anaemia due to dextropropoxyphene paracetamol combination." J R Soc Med 82 (1989): 228

29. Webster GK "Pancytopenia after administration of distalgesic." Br Med J 3 (1973): 353

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

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