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Oxycodone and Acetaminophen (Oxycodone / Acetaminophen) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Serious adverse reactions that may be associated with oxycodone and acetaminophen tablet use include respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, and shock (seeĀ  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 have 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, gastro-intestinal 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



REPORTS OF SUSPECTED OXYCODONE AND ACETAMINOPHEN SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Oxycodone and Acetaminophen. The information is not vetted and should not be considered as verified clinical evidence.

Possible Oxycodone and Acetaminophen side effects / adverse reactions in 69 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-05

Patient: 69 year old male weighing 73.4 kg (161.5 pounds)

Reactions: Product Substitution Issue, Drug Ineffective

Suspect drug(s):
Oxycodone and Acetaminophen
    Dosage: 1-2 p.o. every 4-6 hours prn
    Administration route: Oral
    Indication: Bone Disorder
    Start date: 2011-05-18

Oxycodone and Acetaminophen
    Dosage: 1-2 p.o. every 4-6 hours prn
    Administration route: Oral
    Indication: Chondropathy
    Start date: 2011-05-18

Roxicet
    Dosage: 1-2 p.o. every 4-6 hours prn
    Administration route: Oral
    Indication: Multiple Myeloma
    Start date: 2011-04-07
    End date: 2011-10-01



Possible Oxycodone and Acetaminophen side effects / adverse reactions in 58 year old male

Reported by a physician from United States on 2011-12-23

Patient: 58 year old male

Reactions: Anxiety, Confusional State, Yawning, Insomnia, Inadequate Analgesia, Serotonin Syndrome, Hypertension

Adverse event resulted in: hospitalization

Suspect drug(s):
Mirtazapine
    Dosage: 50 mg;hs;
    Indication: Depression

Fentanyl
    Dosage: 75 ug/hr;q2d;tder
    Indication: Back Pain

Citalopram Hydrobromide
    Dosage: 40 mg;qd;
    Indication: Depression

Oxycodone and Acetaminophen
    Dosage: 5/325 mg;bid;po
    Administration route: Oral
    Indication: Back Pain

Other drugs received by patient: Celecoxib; Doxazosin Mesylate; Zolpidem Extended Extendedrelease



Possible Oxycodone and Acetaminophen side effects / adverse reactions in 31 year old male

Reported by a consumer/non-health professional from United States on 2011-12-27

Patient: 31 year old male weighing 86.6 kg (190.6 pounds)

Reactions: Overdose, Intentional Drug Misuse, Toxicity TO Various Agents

Adverse event resulted in: death

Suspect drug(s):
Oxycodone and Acetaminophen
    Dosage: qid

Amitriptyline

Fentanyl-100
    Dosage: change patches q3d
    Indication: Pain
    Start date: 2008-04-01
    End date: 2008-04-04

Lorazepam

Citalopram Hydrobromide

Other drugs received by patient: Nexium; Lyrica; Seroquel



See index of all Oxycodone and Acetaminophen side effect reports >>

Drug label data at the top of this Page last updated: 2009-04-01

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