ADVERSE REACTIONS
ROXICODONE® tablets have been evaluated in open label clinical trials in patients with cancer and nonmalignant pain. ROXICODONE® tablets are associated with adverse experiences similar to those seen with other opioids.
Serious adverse reactions that may be associated with ROXICODONE® therapy in clinical use are those observed with other opioid analgesics and include: respiratory depression, respiratory arrest, circulatory depression, cardiac arrest, hypotension, and/or shock (see OVERDOSE, WARNINGS).
The less severe adverse events seen on initiation of therapy with ROXICODONE® are also typical opioid side effects. These events 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 analgesia. The most frequent of these include nausea, constipation, vomiting, headache, and pruritus.
In many cases the frequency of adverse events 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 events 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 the open-label and double-blind studies involving ROXICODONE®, the following adverse events were recorded in ROXICODONE® treated patients with an incidence ≥ 3%. In descending order of frequency they were: nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia, and somnolence.
The following adverse experiences occurred in less than 3% of patients involved in clinical trials with oxycodone:
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.
Digestive: anorexia, diarrhea, dyspepsia, dysphagia, gingivitis, glossitis, and nausea and vomiting.
Hemic and Lymphatic: anemia and leukopenia.
Metabolic and Nutritional: edema, gout, hyperglycemia, iron deficiency anemia and peripheral edema.
Musculoskeletal: arthralgia, arthritis, bone pain, myalgia and pathological fracture.
Nervous: agitation, anxiety, confusion, dry mouth, hypertonia, hypesthesia, nervousness, neuralgia, personality disorder, tremor, and vasodilation.
Respiratory: bronchitis, cough increased, dyspnea, epistaxis, laryngismus, lung disorder, pharyngitis, rhinitis, and sinusitis.
Skin and Appendages: herpes simplex, rash, sweating, and urticaria.
Special Senses: amblyopia.
Urogenital: urinary tract infection
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REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO ROXICODONE
Below is a sample of reports where side effects / adverse reactions may be related to Roxicodone. The information is not vetted and should not be cosidered as verified clinical evidence.
Possible Roxicodone side effects / adverse reactions in 39 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2007-02-01
Patient: 39 year old female weighing 56.7 kg (124.7 pounds)
Reactions: Grand MAL Convulsion, Treatment Noncompliance
Adverse event resulted in: hospitalization
Suspect drug(s):
Roxicodone
Dosage: 30 mg;prn;po
Administration route: Oral
Start date: 2005-07-18
Avinza
Dosage: 120 mg;bid;po
Administration route: Oral
Start date: 2006-04-06
Fentanyl Buccal Tablet
Dosage: 800 ug;prn;bucc
Indication: Breakthrough Pain
Start date: 2005-08-09
Fentanyl Buccal Tablet
Dosage: 800 ug;prn;bucc
Indication: Drug Tolerance
Start date: 2005-08-09
Other drugs received by patient: Soma; Xanax; Lexapro; Vytorin; Adderall 10
Possible Roxicodone side effects / adverse reactions in 50 year old male
Reported by a individual with unspecified qualification from United States on 2007-02-12
Patient: 50 year old male
Reactions: Mitral Valve Prolapse, Multiple Drug Overdose Accidental
Adverse event resulted in: death
Suspect drug(s):
Oxycontin
Dosage: unk unk, unk
Indication: Drug USE FOR Unknown Indication
Roxicodone
Dosage: unk unk, unk
Indication: Drug USE FOR Unknown Indication
Xanax
Dosage: unk unk, unk
Indication: Drug USE FOR Unknown Indication
Diazepam
Dosage: unk unk, unk
Indication: Drug USE FOR Unknown Indication
Possible Roxicodone side effects / adverse reactions in 45 year old male
Reported by a individual with unspecified qualification from United States on 2007-02-23
Patient: 45 year old male
Reactions: Visual Acuity Reduced
Suspect drug(s):
Oxycontin
Dosage: unk unk, unk
Indication: Pain
Roxicodone
Dosage: unk unk, unk
Indication: Pain
Pegasys
Dosage: unk unk, unk
Indication: Drug USE FOR Unknown Indication
Start date: 2007-01-12
Ribavirin
Dosage: unk unk, unk
Indication: Drug USE FOR Unknown Indication
Start date: 2007-01-12
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