Drug Information for OXYCODONE AND ACETAMINOPHEN Tablets, USP (American Health Packaging): ADVERSE REACTIONS

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  • Serious adverse reactions that may be associated with oxycodone and acetaminophen tablet use include respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, and shock (see OVERDOSAGE).

    The most frequently observed non-serious adverse reactions include lightheadedness, dizziness, drowsiness or sedation, nausea, and vomiting. These effects seem to be more prominent in ambulatory than in nonambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down. Other adverse reactions include euphoria, dysphoria, constipation, and pruritus. Hypersensitivity reactions may include: Skin eruptions, urticarial, erythematous skin reactions. Hematologic reactions may include: Thrombocytopenia, neutropenia, pancytopenia, hemolytic anemia. Rare cases of agranulocytosis has likewise been associated with acetaminophen use. In high doses, the most serious adverse effect is a dose-dependent, potentially fatal hepatic necrosis. Renal tubular necrosis and hypoglycemic coma also may occur.

    Other adverse reactions obtained from postmarketing experiences with oxycodone and acetaminophen tablets are listed by organ system and in decreasing order of severity and/or frequency as follows:

    Body as a Whole

    Anaphylactoid reaction, allergic reaction, malaise, asthenia, fatigue, chest pain, fever, hypothermia, thirst, headache, increased sweating, accidental overdose, non-accidental overdose

    Cardiovascular

    Hypotension, hypertension, tachycardia, orthostatic hypotension, bradycardia, palpitations, dysrhythmias

    Central and Peripheral Nervous System

    Stupor, tremor, paraesthesia, hypoaesthesia, lethargy, seizures, anxiety, mental impairment, agitation, cerebral edema, confusion, dizziness

    Fluid and Electrolyte

    Dehydration, hyperkalemia, metabolic acidosis, respiratory alkalosis

    Gastrointestinal

    Dyspepsia, taste disturbances, abdominal pain, abdominal distention, sweating increased, diarrhea, dry mouth, flatulence, gastrointestinal disorder, nausea, vomiting, pancreatitis, intestinal obstruction, ileus

    Hepatic

    Transient elevations of hepatic enzymes, increase in bilirubin, hepatitis, hepatic failure, jaundice, hepatotoxicity, hepatic disorder

    Hearing and Vestibular

    Hearing loss, tinnitus

    Hematologic

    Thrombocytopenia

    Hypersensitivity

    Acute anaphylaxis, angioedema, asthma, bronchospasm, laryngeal edema, urticaria, anaphylactoid reaction

    Metabolic and Nutritional

    Hypoglycemia, hyperglycemia, acidosis, alkalosis

    Musculoskeletal

    Myalgia, rhabdomyolysis

    Ocular

    Miosis, visual disturbances, red eye

    Psychiatric

    Drug dependence, drug abuse, insomnia, confusion, anxiety, agitation, depressed level of consciousness, nervousness, hallucination, somnolence, depression, suicide

    Respiratory System

    Bronchospasm, dyspnea, hyperpnea, pulmonary edema, tachypnea, aspiration, hypoventilation, laryngeal edema

    Skin and Appendages

    Erythema, urticaria, rash, flushing

    Urogenital

    Interstitial nephritis, papillary necrosis, proteinuria, renal insufficiency and failure, urinary retention

  • Drug Information Provided by National Library of Medicine (NLM).
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