"July 10, 2015 -- Popular painkillers like ibuprofen and naproxen have carried warnings for years about potential risks of heart attacks and strokes. This week, the FDA decided to strengthen those warnings on the medications, known as nonsteroidal"...
(Generic versions may still be available.)
Darvon Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Darvon (propoxyphene) is a narcotic (opiod) analgesic drug class prescribed to treat mild to moderate pain. The brand name Darvon is no longer available in the U.S. Generic versions may be available. Common side effects of Darvon (propoxyphene) include lightheadedness, drowsiness, dizziness, sleepiness, constipation, nausea, vomiting, stomach pain, headache, muscle pain, blurred vision, or skin rash.
Darvon dosage in adults is 1 capsule (65 mg) or 1 tablet (100 mg) every 4 hours as needed for relief of pain not to exceed 390 mg (capsule) or 600 mg (tablets) in a 24-hour period. Drug interactions with Darvon include alcohol, barbiturates, skeletal muscle relaxants such as carisoprodol (Soma) and cyclobenzaprine (Flexeril) in addition to benzodiazepine sedatives, (for example, diazepam [Valium]) and lorazepam [Ativan]). There are no adequate studies of Darvon in pregnant women and Darvon is found in breast milk.
Our Darvon Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Darvon in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- shallow breathing, slow heartbeat;
- feeling light-headed, fainting;
- confusion, hallucinations, unusual thoughts or behavior;
- seizure (convulsions); or
- jaundice (yellowing of the skin or eyes).
Less serious side effects include:
- feeling dizzy or drowsy;
- nausea, vomiting, stomach pain, constipation;
- headache, muscle pain;
- blurred vision; or
- mild skin rash.
Read the entire detailed patient monograph for Darvon (Propoxyphene)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Darvon Overview - Patient Information: Side Effects
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Darvon (Propoxyphene)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Darvon FDA Prescribing Information: Side Effects
In hospitalized patients, the most frequently reported were dizziness, sedation, nausea, and vomiting. Other adverse reactions include constipation, abdominal pain, skin rashes, lightheadedness, headache, weakness, euphoria, dysphoria, hallucinations, and minor visual disturbances.
The most frequently reported postmarketing adverse events have included completed suicide, accidental and intentional overdose, drug dependence, cardiac arrest, coma, drug ineffective, drug toxicity, nausea, respiratory arrest, cardio-respiratory arrest, death, vomiting, dizziness, convulsion, confusional state, and diarrhea.
Additional adverse experiences reported through postmarketing surveillance include:
Eye disorder: eye swelling, vision blurred
General disorder and administration site conditions: , drug interaction, drug tolerance, drug withdrawal syndrome
Gastrointestinal disorder: gastrointestinal bleed, acute pancreatitis
Hepatobiliary disorder: hepatic steatosis, hepatomegaly, hepatocellular injury
Immune system disorder: hypersensitivity
Injury poisoning and procedural complications: drug toxicity, hip fracture, multiple drug overdose, narcotic overdose
Metabolism and nutrition disorder: metabolic acidosis
Psychiatric: abnormal behavior, confusional state, hallucinations, mental status change
Respiratory, thoracic, and mediastinal disorders: respiratory depression, dyspnoea
Skin and subcutaneous tissue disorder: rash, itch
Liver dysfunction has been reported in association with Darvon. 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 been reported following chronic propoxyphene overdosage.
Drug Abuse And Dependence
Darvon (propoxyphene) is a Schedule IV narcotic under the U.S. Controlled Substances Act. Darvon (propoxyphene) can produce drug dependence of the morphine type, and therefore, has the potential for being abused. Psychic dependence, physical dependence and tolerance may develop upon repeated administration. Darvon (propoxyphene) should be prescribed and administered with the same degree of caution appropriate to the use of other narcotic-containing medications.
Since Darvon (propoxyphene) is a mu-opioid agonist, it may be subject to misuse, abuse, and addiction. Addiction to opioids prescribed for pain management has not been estimated. However, requests for opioids from opioid-addicted patients occur. As such, physicians should take appropriate care in prescribing Darvon (propoxyphene) .
Opioid analgesics may cause psychological and physical dependence. Physical dependence results in withdrawal symptoms in patients who abruptly discontinue the drug after long term administration. Also, symptoms of withdrawal may be precipitated through the administration of drugs with mu-opioid antagonist activity, e.g., naloxone or mixed agonist/antagonist analgesics (pentazocine, butorphanol, nalbuphine, dezocine) (see OVERDOSAGE). Physical dependence usually does not occur to a clinically significant degree, until after several weeks of continued opioid usage. Tolerance, in which increasingly larger doses are required to produce the same degree of analgesia, is initially manifested by a shortened duration of an analgesic effect and subsequently, by decreases in the intensity of analgesia.
In chronic pain patients, and in opioid-tolerant cancer patients, the administration of Darvon (propoxyphene) should be guided by the degree of tolerance manifested and the doses needed to adequately relieve pain.
The severity of the Darvon (propoxyphene) abstinence syndrome may depend on the degree of physical dependence. Withdrawal is characterized by rhinitis, myalgia, abdominal cramping, and occasional diarrhea. Most observable symptoms disappear in 5 to 14 days without treatment; however, there may be a phase of secondary or chronic abstinence which may last for 2 to 6 months characterized by insomnia, irritability, and muscular aches. The patient may be detoxified by gradual reduction of the dose. Gastrointestinal disturbances or dehydration should be treated with supportive care.
Read the entire FDA prescribing information for Darvon (Propoxyphene)
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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