ADVERSE REACTIONS
The safety of oxycodone hydrochloride extended-release tablets was evaluated in double-blind clinical trials involving 713 patients with moderate to severe pain of various etiologies. In open-label studies of cancer pain, 187 patients received oxycodone hydrochloride extended-release tablets in total daily doses ranging from 20 mg to 640 mg per day. The average total daily dose was approximately 105 mg per day.
Serious adverse reactions which may be associated with oxycodone hydrochloride extended-release tablet therapy in clinical use are those observed with other opioid analgesics, including respiratory depression, apnea, respiratory arrest, and (to an even lesser degree) circulatory depression, hypotension, or shock (see OVERDOSAGE).
The non-serious adverse events seen on initiation of therapy with oxycodone hydrochloride extended-release tablets are typical opioid side effects. These events are dose-dependent, and their frequency depends upon the dose, 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 (>5%) include: constipation, nausea, somnolence, dizziness, vomiting, pruritus, headache, dry mouth, sweating, and asthenia.
In many cases the frequency of these events during initiation of therapy may be minimized by careful individualization of starting dosage, slow titration, and the avoidance of large swings in the plasma concentrations of the opioid. Many of these adverse events will cease or decrease in intensity as oxycodone hydrochloride extended-release tablets therapy is continued and some degree of tolerance is developed.
Clinical trials comparing oxycodone hydrochloride extended-release tablets with immediate-release oxycodone and placebo, revealed a similar adverse event profile between oxycodone hydrochloride extended-release tablets and immediate-release oxycodone. The most common adverse events (>5%) reported by patients at least once during therapy were:
Table 3 | Oxycodone Hydrochloride Extended-Release Tablets (n=227) | Oxycodone Hydrochloride Immediate-Release Tablets (n=225) | Placebo (n=45) |
| (%) | (%) | (%) |
| Constipation | 23 | 26 | 7 |
| Nausea | 23 | 27 | 11 |
| Somnolence | 23 | 24 | 4 |
| Dizziness | 13 | 16 | 9 |
| Pruritus | 13 | 12 | 2 |
| Vomiting | 12 | 14 | 7 |
| Headache | 7 | 8 | 7 |
| Dry Mouth | 6 | 7 | 2 |
| Asthenia | 6 | 7 | -- |
| Sweating | 5 | 6 | 2 |
The following adverse experiences were reported in oxycodone hydrochloride extended-release tablets treated patients with an incidence between 1% and 5%. In descending order of frequency they were anorexia, nervousness, insomnia, fever, confusion, diarrhea, abdominal pain, dyspepsia, rash, anxiety, euphoria, dyspnea, postural hypotension, chills, twitching, gastritis, abnormal dreams, thought abnormalities, and hiccups.
The following adverse reactions occurred in less than 1% of patients involved in clinical trials or were reported in post marketing experience:
General: accidental injury, chest pain, facial edema, malaise, neck pain, pain, and symptoms associated with either an anaphylactic or anaphylactoid reaction
Cardiovascular: migraine, syncope, vasodilation, ST depression
Digestive: dysphagia, eructation, flatulence, gastrointestinal disorder, increased appetite, nausea and vomiting, stomatitis, ileus
Hemic and Lymphatic: lymphadenopathy
Metabolic and Nutritional: dehydration, edema, hyponatremia, peripheral edema, syndrome of inappropriate antidiuretic hormone secretion, thirst
Nervous: abnormal gait, agitation, amnesia, depersonalization, depression, emotional lability, hallucination, hyperkinesia, hypesthesia, hypotonia, malaise, paresthesia, seizures, speech disorder, stupor, tinnitus, tremor, vertigo, withdrawal syndrome with or without seizures
Respiratory: cough increased, pharyngitis, voice alteration
Skin: dry skin, exfoliative dermatitis, urticaria
Special Senses: abnormal vision, taste perversion
Urogenital: amenorrhea, decreased libido, dysuria, hematuria, impotence, polyuria, urinary retention, urination impaired
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REPORTS OF SUSPECTED OXYCODONE SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Oxycodone. The information is not vetted and should not be considered as verified clinical evidence.
Possible Oxycodone side effects / adverse reactions in 50 year old male
Reported by a health professional (non-physician/pharmacist) from Canada on 2011-11-04
Patient: 50 year old male
Reactions: Toxicity TO Various Agents
Adverse event resulted in: death
Suspect drug(s):
Alprazolam
Dosage: unk
Nortriptyline HCL
Dosage: unk
Ethanol
Dosage: unk
Oxycodone
Dosage: unk
Temazepam
Dosage: unk
Enbrel
Dosage: 50 mg, 2 times/wk
Amitriptyline
Dosage: unk
Citalopram
Dosage: unk
Oxazepam
Dosage: unk
Possible Oxycodone side effects / adverse reactions in 50 year old male
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-13
Patient: 50 year old male
Reactions: Toxicity TO Various Agents
Adverse event resulted in: death
Suspect drug(s):
Oxycodone
Dosage: unk
Temazepam
Dosage: 50 mg, 2 times/wk
Amitriptyline HCL
Dosage: unk
Oxazepam
Dosage: unk
Alprazolam
Dosage: unk
Enbrel
Dosage: 50 mg, 2 times/wk
Indication: Product Used FOR Unknown Indication
Ethanol
Dosage: unk
Nortriptyline
Dosage: unk
Citalopram
Dosage: unk
Possible Oxycodone side effects / adverse reactions in 50 year old male
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-17
Patient: 50 year old male
Reactions: Toxicity TO Various Agents
Adverse event resulted in: death
Suspect drug(s):
Enbrel
Dosage: 50 mg, 2 times/wk
Indication: Product Used FOR Unknown Indication
Ethanol
Dosage: unk
Indication: Product Used FOR Unknown Indication
Amitriptyline HCL
Dosage: unk
Indication: Product Used FOR Unknown Indication
Citalopram
Dosage: unk
Indication: Product Used FOR Unknown Indication
Alprazolam
Dosage: unk
Indication: Product Used FOR Unknown Indication
Oxazepam
Dosage: unk
Indication: Product Used FOR Unknown Indication
Oxycodone
Dosage: unk
Indication: Product Used FOR Unknown Indication
Temazepam
Dosage: 50 mg, 2x/week
Indication: Product Used FOR Unknown Indication
Nortriptyline
Dosage: unk
Indication: Product Used FOR Unknown Indication
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