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Serious adverse reactions that may be associated with PERCODAN (aspirin and oxycodone hydrochloride) tablet use include respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, and shock (see OVERDOSE).

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.

Aspirin may increase the likelihood of hemorrhage due to its effect on the gastric mucosa and platelet function. Furthermore, aspirin has the potential to cause anaphylaxis in hypersensitive patients as well as angioedema especially in patients with chronic urticaria. Other adverse reactions due to aspirin use include anorexia, reversible hepatotoxicity, leukopenia, thrombocytopenia, purpura, decreased plasma iron concentration, and shortened erythrocyte survival time.

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

Body as a Whole

allergic reaction, malaise, asthenia, headache, anaphylaxis, fever, hypothermia, thirst, increased sweating, accident, accidental overdose, non-accidental overdose.

Cardiovascular

tachycardia, dysrhythmias, hypotension, orthostatic hypotension, bradycardia, palpitations

Central and Peripheral Nervous System

stupor, paresthesia, agitation, cerebral edema, coma, confusion, dizziness, headache, subdural or intracranial hemorrhage, lethargy, seizures, anxiety, mental impairment

Fluid and Electrolyte

dehydration, hyperkalemia, metabolic acidosis, respiratory alkalosis

Gastrointestinal

hemorrhagic gastric/duodenal ulcer, gastric/peptic ulcer, dyspepsia, abdominal pain, diarrhea, eructation, dry mouth, gastrointestinal bleeding, intestinal perforation, nausea, vomiting, transient elevations of hepatic enzymes, hepatitis, Reye syndrome, pancreatitis, intestinal obstruction, ileus

Hearing and Vestibular

hearing loss, tinnitus. Patients with high frequency loss may have difficulty perceiving tinnitus. In these patients, tinnitus cannot be used as a clinical indicator of salicylism.

Hematologic

unspecified hemorrhage, purpura, reticulocytosis, prolongation of prothrombin time, disseminated intravascular coagulation, ecchymosis, thrombocytopenia

Hypersensitivity

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

Metabolic and Nutritional

hypoglycemia, hyperglycemia, acidosis, alkalosis

Musculoskeletal

rhabdomyolysis

Ocular

miosis, visual disturbances, red eye

Psychiatric

drug dependence, drug abuse, somnolence, depression, nervousness, hallucination

Reproductive

prolonged pregnancy and labor, stillbirths, lower birth weight infants, antepartum and postpartum bleeding, closure of patent ductus arteriosis

Respiratory System

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

Skin and Appendages

urticaria, rash, flushing

Urogenital

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