Medical Editor: John P. Cunha, DO, FACOEP
Roxybond (oxycodone hydrochloride) tablets are an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Roxybond is available in generic form. Common side effects of Roxybond include:
- weakness or lack of energy, and
The initial dose of Roxybond is a range of 5 to 15 mg every 4 to 6 hours as needed for pain. The dose of Roxybond is individualized based on severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse. Roxybond may interact with macrolide antibiotics, azole antifungals, protease inhibitors, rifampin, carbamazepine, phenytoin, benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol, selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), monoamine oxidase (MAO) inhibitors, muscle relaxants, diuretics, and antiocholinergics. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Roxybond; prolonged use of opioid analgesics such as Roxybond during pregnancy may cause neonatal opioid withdrawal syndrome. Roxybond passes into breast milk. Consult your doctor before breastfeeding. Withdrawal symptoms may occur if you suddenly stop taking Roxybond.
Our Roxybond (oxycodone hydrochloride) Tablets 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 are 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, 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.
Oxycodone hydrochloride tablets have been evaluated in open label clinical trials in patients with cancer and nonmalignant pain. Oxycodone hydrochloride tablets are associated with adverse experiences similar to those seen with other opioids.
Serious adverse reactions that may be associated with ROXYBOND therapy include: respiratory depression, respiratory arrest, circulatory depression, cardiac arrest, hypotension, and/or shock.
The common adverse reactions seen on initiation of therapy with oxycodone hydrochloride tablets are dose related and are opioid-related adverse reactions. The most frequent of these included nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia, and somnolence. 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 oxycodone hydrochloride tablets, the following adverse events were recorded in oxycodone hydrochloride treated patients with an incidence ≥ 3%. In descending order of frequency they were: nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia, and somnolence.
Other less frequently observed adverse reactions from opioid analgesics, including oxycodone hydrochloride tablets included: Blood and lymphatic system disorders: anemia, leukopenia
Cardiac disorders: cardiac failure, palpitation, tachycardia Gastrointestinal disorders: abdominal pain, dry mouth, diarrhea, dyspepsia, dysphagia, glossitis, nausea, vomiting
General disorders and administration site conditions: chills, edema, edema peripheral, pain, pyrexia
Immune system disorders: hypersensitivity
Infections and infestations: bronchitis, gingivitis, infection, pharyngitis, rhinitis, sepsis, sinusitis, urinary tract infection
Injury, poisoning, and procedural complications: injury
Metabolism and nutritional disorders: decreased appetite, gout, hyperglycemia
Musculoskeletal and connective tissue disorders: arthralgia, arthritis, back pain, bone pain, myalgia, neck pain, pathological fracture
Nervous system disorders: hypertonia, hypoesthesia, migraine, neuralgia, tremor, vasodilation
Psychiatric disorders: agitation, anxiety, confusional state, nervousness, personality disorder
Respiratory, thoracic, and mediastinal disorders: cough, dyspnea, epistaxis, laryngospasm, lung disorder
Skin and subcutaneous tissue disorders: photosensitivity reaction, rash, hyperhidrosis, urticaria
Vascular disorders: thrombophlebitis, hemorrhage, hypotension, vasodilation
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.
General disorders and administrative site disorders: drug withdrawal syndrome neonatal [see WARNINGS AND PRECAUTIONS]
Respiratory, thoracic, and mediastinal disorders: pharyngeal edema
Serotonin syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs [see DRUG INTERACTIONS].
Adrenal insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use [see WARNINGS AND PRECAUTIONS].
Anaphylaxis: Anaphylactic reaction has been reported with ingredients contained in ROXYBOND [see CONTRAINDICATIONS].
Androgen deficiency: Cases of androgen deficiency have occurred with chronic use of opioids [see CLINICAL PHARMACOLOGY].
Read the entire FDA prescribing information for RoxyBond (Oxycodone Hydrochloride Tablets)