Darvon-N Side Effects

Generic Name: propoxyphene

Please note - some side effects for Darvon-N may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Darvon-N - for the Consumer

Darvon-N

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 Darvon-N:

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.

Darvon-N Side Effects - for the Professional

Darvon-N

In a survey conducted in hospitalized patients, less than 1% of patients taking propoxyphene hydrochloride at recommended doses experienced side effects. The most frequently reported were dizziness, sedation, nausea, and vomiting. Some of these adverse reactions may be alleviated if the patient lies down.

Other adverse reactions include constipation, abdominal pain, skin rashes, lightheadedness, headache, weakness, euphoria, dysphoria, hallucinations, and minor visual disturbances.

Propoxyphene therapy has been associated with abnormal liver function tests and, more rarely, with instances of reversible jaundice (including cholestatic jaundice).

Subacute painful myopathy has occurred following chronic propoxyphene overdosage.

Side Effects by Body System

General

In general, the adverse effects of propoxyphene may be more likely and more severe in patients with renal and/or liver disease.

Nervous system

Nervous system side effects have included dizziness, sedation, stupor, delirium, somnolence, 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.

Sensorineural deafness has been reported following chronic abuse and/or large doses of propoxyphene-containing compounds. Optic atrophy has been reported following overdose.

Cardiovascular

Some of the cardiotoxic effects reported in association with propoxyphene may be attributable to its major active metabolite, norpropoxyphene.

Cardiovascular side effects have included hypotension and dizziness. A variety of arrhythmias (including heart block) have been reported most often in association with propoxyphene overdose.

Gastrointestinal

A case of ischemic colitis has been reported following an overdose of propoxyphene which was complicated by severe hypotension.

Gastrointestinal side effects have included nausea, vomiting, and constipation which have been relatively common.

Genitourinary

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

Dermatologic

Dermatologic side effects including rashes 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, 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 include 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 cases of severe hypoglycemia have been reported in patients with chronic renal failure.

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