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Oxycontin (Oxycodone Hydrochloride) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

The safety of OxyContin® 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 OxyContin 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 OxyContin 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 OxyContin 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 OxyContin therapy is continued and some degree of tolerance is developed.

Clinical trials comparing OxyContin with immediate-release oxycodone and placebo revealed a similar adverse event profile between OxyContin and immediate-release oxycodone. The most common adverse events (>5%) reported by patients at least once during therapy were:

TABLE 3
OxyContin
(n=227)
Immediate-Release
(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 OxyContin®-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 postmarketing 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



REPORTS OF SUSPECTED OXYCONTIN SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Oxycontin. The information is not vetted and should not be considered as verified clinical evidence.

Possible Oxycontin side effects / adverse reactions in 61 year old male

Reported by a consumer/non-health professional from United States on 2011-10-04

Patient: 61 year old male weighing 156.1 kg (343.4 pounds)

Reactions: Abdominal Discomfort, Cellulitis, Diarrhoea, Nausea, Drug Ineffective, Unevaluable Event, Headache

Adverse event resulted in: hospitalization

Suspect drug(s):
Oxycontin



Possible Oxycontin side effects / adverse reactions in 15 year old male

Reported by a physician from United States on 2011-10-04

Patient: 15 year old male

Reactions: Death, Drug Administration Error, Depressed Level of Consciousness, Headache

Adverse event resulted in: death

Suspect drug(s):
Oxycontin
    Dosage: 80mg single dose
    Indication: Product Used FOR Unknown Indication

Imitrex
    Indication: Product Used FOR Unknown Indication

Adderall 5
    Indication: Product Used FOR Unknown Indication



Possible Oxycontin side effects / adverse reactions in 72 year old male

Reported by a pharmacist from United States on 2011-10-05

Patient: 72 year old male weighing 75.3 kg (165.7 pounds)

Reactions: Nausea

Suspect drug(s):
Oxycontin



See index of all Oxycontin side effect reports >>

Drug label data at the top of this Page last updated: 2007-02-13

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