"The the European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) will review the risks and benefits of modified- and prolonged-release paracetamol (acetaminophen) tablets, the agency said today.
(Generic versions may still be available.)
Darvon Compound Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Darvon Compound (propoxyphene hydrochloride, aspirin, caffeine) is a combination of a narcotic pain reliever, aspirin, and caffeine used to treat moderate-to-severe pain. The brand name Darvon Compound is discontinued, but generic versions may be available. Common side effects of Darvon Compound (propoxyphene hydrochloride, aspirin, caffeine) include:
- dry mouth
- decreased appetite
- muscle twitches
- decreased urination
- decreased sex drive, or
- ringing in the ears
The usual dosage of Darvon Compound is 65 mg propoxyphene hydrochloride, 389 mg aspirin and 32.4 mg caffeine (one capsule) every 4 hours as needed for pain. Darvon Compound may interact with anticoagulants, carbamazepine, monoamine oxidase inhibitors (MAOIs), antidepressants, alcohol, antihistamines, sedatives, other pain relievers, anxiety medicines, muscle relaxants, or over-the-counter and prescription products containing aspirin. Tell your doctor all medications and supplements you use. The propoxyphene in Darvon Compound may cause addiction and withdrawal symptoms as well as other harmful effects in a fetus. Do not take Darvon Compound without first talking to your doctor if you are pregnant or could become pregnant during treatment. Propoxyphene may also cause addiction and withdrawal symptoms in a nursing baby. Consult your doctor before breastfeeding. Withdrawal symptoms may occur if you suddenly stop taking this medication.
Our Darvon Compound (propoxyphene hydrochloride, aspirin, caffeine) 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 Compound in Detail - Patient Information: Side Effects
If you experience any of the following serious side effects, stop taking aspirin/caffeine/propoxyphene and seek emergency medical attention or contact your doctor immediately:
- an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
- slow, weak breathing;
- cold, clammy skin;
- severe weakness or dizziness;
- unconsciousness; or
- black, bloody, or tarry stools or blood in your urine or vomit.
Other, less serious side effects may be more likely to occur. Continue to take aspirin/caffeine/propoxyphene and talk to your doctor if you experience
- dry mouth, nausea, vomiting, or decreased appetite;
- dizziness, tiredness, or lightheadedness;
- muscle twitches;
- decreased urination;
- decreased sex drive; or
- ringing in the ears.
Propoxyphene may be habit forming. Physical and/or psychological dependence can occur, and withdrawal effects are possible if the medication is stopped suddenly after prolonged or high-dose treatment. Do not stop taking aspirin/caffeine/propoxyphene suddenly without first talking to your doctor if you have been taking it continuously for more than 5 to 7 days. Your doctor may want to gradually reduce the dose.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Darvon Compound (Propoxyphene, Aspirin, and Caffeine)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Darvon Compound FDA Prescribing Information: Side Effects
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.
Read the entire FDA prescribing information for Darvon Compound (Propoxyphene, Aspirin, and Caffeine)
Additional Darvon Compound Information
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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