PP-Cap Side Effects
Generic name: propoxyphene
Note: This document provides detailed information about PP-Cap Side Effects associated with propoxyphene. Some dosage forms listed on this page may not apply specifically to the brand name PP-Cap.
Applies to propoxyphene: oral capsule, oral suspension, oral tablet.
Important warnings
This medicine can cause some serious health issues
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.
Common side effects of PP-Cap
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 side effects
- 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
Serious side effects of PP-Cap
Along with its needed effects, propoxyphene (the active ingredient contained in PP-Cap) 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 side effects
- 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
Get emergency help immediately if any of the following symptoms of overdose occur while taking propoxyphene:
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
For healthcare professionals
Applies to propoxyphene: oral capsule, oral tablet.
General adverse events
In general, the adverse effects of propoxyphene (the active ingredient contained in PP-Cap) 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 PP-Cap) 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 PP-Cap) 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
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 (the active ingredient contained in PP-Cap) overdose.[Ref]
Some of the cardiotoxic effects reported in association with propoxyphene may be attributable to its major active metabolite, norpropoxyphene.[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 PP-Cap) (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
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2. Rosenow EC 3d (1972) "The spectrum of drug-induced pulmonary disease." Ann Intern Med, 77, p. 977-91
3. Shorr RI, Griffin MR, Daugherty JR, Ray WA (1992) "Opioid analgesics and the risk of hip fracture in the elderly: codeine and propoxyphene." J Gerontol, 47, M111-5
4. Ng B, Alvear M (1993) "Dextropropoxyphene addiction--a drug of primary abuse." Am J Drug Alcohol Abuse, 19, p. 153-8
5. Critchley J, Illingworth RN, Pottage A, Proudfoot AT, Prescott L (1979) "Acute poisoning with distalgesic." Br Med J, 1, p. 342-3
6. (2001) "Product Information. Darvon (propoxyphene)." Lilly, Eli and Company
7. Hedenmalm K (1995) "A case of severe withdrawal syndrome due to dextropropoxyphene." Ann Intern Med, 123, p. 473
8. Strode SW (1985) "Propoxyphene dependence and withdrawal." Am Fam Physician, 32, p. 105-8
9. Wall R, Linford SM, Akhter MI (1980) "Addiction to Distalgesic (dextropropoxyphene)." Br Med J, 280, p. 1213-4
10. Salguero CH, Villarreal JE, Hug CC Jr, Domino EF (1969) "Propoxyphene dependence." JAMA, 210, p. 135-6
11. Claghorn JL, Schoolar JC (1966) "Propoxyphene hydrochloride, a drug of abuse." JAMA, 196, p. 1089-91
12. Whittington RM (1979) "Dextropropoxyphene addiction." Lancet, 2, p. 743-4
13. Harris B, Harper M (1979) "Psychosis after dextropropoxyphene." Lancet, 2, p. 743
14. Owen M, Hills LJ (1980) "How safe is dextropropoxyphene?." Med J Aust, 1, p. 617-8
15. Collins GB, Kiefer KS (1981) "Propoxyphene dependence: an update." Postgrad Med, 70, p. 57-61
16. Heaney RM (1983) "Left bundle branch block associated with propoxyphene hydrochloride poisoning." Ann Emerg Med, 12, p. 780-2
17. Briggs RS, Barrand KG, Levene M (1977) "Ischaemic colitis and drug abuse." Br Med J, 2, p. 1478
18. Critchley JA, Smith MF, Prescott LF (1985) "Distalgesic abuse and retroperitoneal fibrosis." Br J Urol, 57, p. 486-7
19. Wiederholt IC, Genco M, Foley JM (1967) "Recurrent episodes of hypoglycemia induced by propoxyphene." Neurology, 17, p. 703-6
20. Singer I, Forrest JN Jr (1976) "Drug-induced states of nephrogenic diabetes insipidus." Kidney Int, 10, p. 82-95
21. Almirall J, Montoliu J, Torras A, Revert L (1989) "Propoxyphene-induced hypoglycemia in a patient with chronic renal failure." Nephron, 53, p. 273-5
22. Klein NC, Magida MG (1971) "Propoxyphene (Darvon) hepatotoxicity." Am J Dig Dis, 16, p. 467-9
23. Ford MJ, Kellett RJ, Busuttil A, Finlayson ND (1977) "Dextropropoxyphene and jaundice." Br Med J, 2, p. 674
24. Lee TH, Rees PJ (1977) "Hepatotoxicity of dextropropoxyphene." Br Med J, 2, p. 296-7
25. Bassendine MF, Woodhouse KW, Bennett M, James OF (1986) "Dextropropoxyphene induced hepatotoxicity mimicking biliary tract disease." Gut, 27, p. 444-9
26. Daikos GK, Kosmidis JC (1975) "Propoxyphene jaundice." JAMA, 232, p. 835
27. (1979) "Dextropropoxyphene." Med J Aust, 2, p. 494
28. Webster GK (1973) "Pancytopenia after administration of distalgesic." Br Med J, 3, p. 353
29. Fulton JD, McGonigal G (1989) "Steroid responsive haemolytic anaemia due to dextropropoxyphene paracetamol combination." J R Soc Med, 82, p. 228
30. Fisch HP, Wands J, Yeung J, Davis PJ (1972) "Pulmonary edema and disseminated intravascular coagulation after intravenous abuse of d-propoxyphene (darvon)." South Med J, 65, p. 493-5
31. Pearlman HS, Wollowick BS, Alvarez EV (1970) "Intra-arterial injection of propoxyphene into brachial artery." JAMA, 214, p. 2055-7
32. Dalakas MC (1986) "Subacute painful myopathy from chronic propoxyphene napsylate abuse." JAMA, 255, p. 1709
33. Restrepo JF, Guzman R, Pena MA, Lizarazo H, Mendez O, Rondon F, Iglesias A (1993) "Fibrous myopathy induced by propoxyphene injections." J Rheumatol, 20, p. 596-7
More about PP-Cap (propoxyphene)
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Further information
PP-Cap side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.