Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following serious adverse reactions are described, or described in greater detail, in other sections: • Addiction, Abuse, and Misuse [see Warnings and Precautions (5.2)] • Life-Threatening Respiratory Depression [see Warnings and Precautions (5.4)] • Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.5)] • Interactions with Benzodiazepines or Other CNS Depressants [see Warnings and Precautions (5.7)] • Adrenal Insufficiency [see Warnings and Precautions (5.9)] • Severe Hypotension [see Warnings and Precautions (5.10)] • Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.12)] • Seizures [see Warnings and Precautions (5.13)] • Withdrawal [see Warnings and Precautions (5.14)] The following adverse reactions associated with the use of oxycodone were identified in clinical studies or post marketing reports.
Because some of these reactions were 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.
Serious adverse reactions associated with oxycodone use included: respiratory depression, respiratory arrest, circulatory depression, cardiac arrest, hypotension, and/or shock.
The common adverse reactions seen on initiation of therapy with oxycodone are dose-related and are typical opioid-related adverse reactions.
The most frequent adverse events include nausea, constipation, vomiting, headache, and pruritus.
The frequency of these reactions depended on several factors, including clinical setting, the patient’s level of opioid tolerance, and host factors specific to the individual.
In all patients for whom dosing information was available (n=191) from the open-label and double-blind studies involving another formulation of immediate-release oxycodone, the following adverse events were recorded in oxycodone treated patients with an incidence ≥ 3%.
In descending order of frequency, they were: nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia, and somnolence.
The other less frequently observed adverse reactions from opioid analgesics, including Oxycodone Hydrochloride Oral Solution included: Body as a Whole: abdominal pain, accidental injury, allergic reaction, back pain, chills and fever, fever, flu syndrome, infection, neck pain, pain, photosensitivity reaction, and sepsis.
Cardiovascular: deep thrombophlebitis, heart failure, hemorrhage, hypotension, migraine, palpitation, and tachycardia.
5 WARNINGS AND PRECAUTIONS • Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely, particularly during initiation and titration.( 5.8) • Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid.
( 5.9 ) • Severe Hypotension: Monitor during dosage initiation and titration.
Avoid use of Oxycodone Hydrochloride Oral Solution in patients with circulatory shock .(5.10) • Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: Monitor for sedation and respiratory depression.
Avoid use of Oxycodone Hydrochloride Oral Solution in patients with impaired consciousness or coma.
( 5.11 ) 5.1 Risk of Accidental Overdose and Death due to Medication Errors Dosing errors can result in accidental overdose and death.
Like all medications, Oxycodone Hydrochloride Oral Solution can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: