Oxycodone and Aspirin - Side Effects Oxycodone Hydrochloride and Aspirin

The following serious adverse reactions are described, or described in greater detail, in other sections:

• Addiction, Abuse, and Misuse (see WARNINGS)
• Life-Threatening Respiratory Depression (see WARNINGS)
• Neonatal Opioid Withdrawal Syndrome (see WARNINGS)
• Interactions with Benzodiazepines and Other CNS Depressants (see WARNINGS) Adrenal Insufficiency (see WARNINGS)
• Severe Hypotension (see WARNINGS)
• Gastrointestinal Adverse Reactions (see WARNINGS)
• Seizures (see WARNINGS)
• Withdrawal (see WARNINGS)

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Serious adverse reactions that may be associated with oxycodone and aspirin tablets tablet use include, apnea, circulatory depression, hypotension, respiratory arrest, respiratory depression, 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.

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.

The following adverse reactions have been identified during post approval use of oxycodone. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The adverse reactions obtained from postmarketing experiences with oxycodone and aspirin 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 & peripheral nervous system

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

fluid & 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 & 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 & 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 & appendages

urticaria, rash, flushing

urogenital

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

serotonin syndrome

Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.

adrenal insufficiency

Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.

anaphylaxis

Anaphylaxis has been reported with ingredients contained in oxycodone and aspirin tablets.

androgen deficiency

Cases of androgen deficiency have occurred with chronic use of opioids (see CLINICAL PHARMACOLOGY).