Medical Editor: John P. Cunha, DO, FACOEP
What Is Oxaydo?
What Are Side Effects of Oxaydo?
Common side effects of Oxaydo include:
- sleep problems (insomnia),
- abdominal pain,
- allergic reaction,
- back pain,
- neck pain,
- skin sensitivity to sunlight,
- low blood pressure,
- slow heart rate,
- loss of appetite,
- difficulty swallowing,
- swollen tongue,
- high blood sugar,
- iron deficiency anemia,
- swelling in extremities,
- joint pain,
- bone pain,
- muscle pain,
- dry mouth,
- shortness of breath,
- sore throat,
- runny or stuffy nose,
- vision problems, and
- urinary tract infection.
Dosage for Oxaydo
The starting dosage of Oxaydo is 5 to 15 mg every 4 to 6 hours as needed for pain.
What Drugs, Substances, or Supplements Interact with Oxaydo?
Oxaydo may interact with:
- central nervous system (CNS) depressants (including sedatives, hypnotics, general anesthetics, antiemetics, phenothiazines, other tranquilizers, and alcohol),
- skeletal muscle relaxants,
- mixed agonist/antagonist analgesics,
- monoamine oxidase inhibitors (MAOIs),
- macrolide antibiotics,
- protease inhibitors,
- cardiovascular drugs (including amiodarone and quinidine),
- antidepressants, and
- anticholinergics or other medications with anticholinergic activity
Tell your doctor all medications and supplements you use.
Oxaydo During Pregnancy and Breastfeeding
During pregnancy, Oxaydo should only be taken if prescribed. Neonates whose mothers have taken oxycodone chronically may exhibit respiratory depression and/or withdrawal symptoms, either at birth and/or in the nursery.
Additional InformationOxaydo is not recommended for use during labor or while breastfeeding. Withdrawal symptoms may occur if you suddenly stop taking Oxaydo. Our Oxaydo (oxycodone) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
The following serious adverse reactions are described, or described in greater detail, in other sections:
- Addiction, Abuse, and Misuse [see WARNINGS AND PRECAUTIONS]
- Life-Threatening Respiratory Depression [see WARNINGS AND PRECAUTIONS]
- Neonatal Opioid Withdrawal Syndrome [see WARNINGS AND PRECAUTIONS]
- Interactions with Benzodiazepines or Other CNS Depressants [see WARNINGS AND PRECAUTIONS]
- Adrenal Insufficiency [see WARNINGS AND PRECAUTIONS]
- Severe Hypotension [see WARNINGS AND PRECAUTIONS]
- Gastrointestinal Adverse Reactions [see WARNINGS AND PRECAUTIONS]
- Seizures [see WARNINGS AND PRECAUTIONS]
- Withdrawal [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, the 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 clinical practice.
Serious adverse reactions that may be associated with OXAYDO include: respiratory depression, respiratory arrest, circulatory depression, cardiac arrest, hypotension, and/or shock [see WARNINGS AND PRECAUTIONS and OVERDOSE].
The common adverse reactions seen on initiation of therapy with OXAYDO are dose-dependent, and their frequency depends on the clinical setting, the patient’s level of opioid tolerance, and host factors specific to the individual. They should be expected and managed as a part of opioid therapy. The most frequent of the adverse reactions include nausea, constipation, vomiting, headache, and pruritus.
The frequency of adverse reactions during initiation of opioid therapy may be minimized by careful individualization of starting dosage, slow titration and the avoidance of large rapid swings in plasma concentration of the opioid. Many of these adverse reactions will abate as therapy is continued and some degree of tolerance is developed, but others may be expected to remain throughout therapy.
In all patients for whom dosing information was available (n=191) from open-label and double-blind studies involving oxycodone, the following adverse reactions were recorded in oxycodone-treated patients with an incidence of ≥3%. In descending order of frequency they were: nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia, and somnolence.
The following adverse reactions occurred in less than 3% of patients involved in clinical trials with oxycodone:
Special Senses: amblyopia.
Urogenital: urinary tract infection.
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. These events include:
Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.
Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.
Anaphylaxis has been reported with ingredients contained in OXAYDO.
Read the entire FDA prescribing information for Oxaydo (Oxycodone HCl USP Tablets)