Oxycodone (Oxycodone Hydrochloride) - Side Effects and Adverse Reactions

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

REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO OXYCODONE

Possible Oxycodone side effects / adverse reactions in 54 year old male

Reported by a physician from Spain on 2007-02-12

Patient: 54 year old male

Reactions: Serotonin Syndrome

Adverse event resulted in: life threatening event

Suspect drug(s):
Invanz
    Indication: Cellulitis
    Start date: 2007-01-01
    End date: 2007-02-01

Oxycodone

Fentanyl

Citalopram
    Start date: 2005-01-01
    End date: 2007-01-01

Citalopram
    End date: 2007-01-01

Other drugs received by patient: Amitriptyline Hydrochloride; Gabapentin; Clonazepam; [therapy Unspecified]

Possible Oxycodone side effects / adverse reactions in 82 year old female

Reported by a pharmacist from United States on 2007-03-02

Patient: 82 year old female weighing 59.4 kg (130.7 pounds)

Reactions: Depressed Level of Consciousness

Adverse event resulted in: hospitalization

Suspect drug(s):
Pregabalin 100mg
    Dosage: 100mg po bid peripheral neuropathy
    Administration route: Oral
    Indication: Neuropathy Peripheral

Oxycodone
    Dosage: 20mg po bid
    Administration route: Oral
    Indication: Neuropathy Peripheral

Other drugs received by patient: Digoxin; Prilosec; Dyazide; Elavil; Metoprolol Succinate; Levothyroxine Sodium; Oxycontin

Possible Oxycodone side effects / adverse reactions in 53 year old male

Reported by a consumer/non-health professional from United States on 2007-03-07

Patient: 53 year old male weighing 74.8 kg (164.7 pounds)

Reactions: Confusional State, Burns Fourth Degree, Abnormal Behaviour, Cognitive Disorder, Cerebrovascular Accident, Personality Disorder, Treatment Noncompliance, Cardio-Respiratory Arrest, Medication Error, Burns Third Degree, Hypertension

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
PEG-Intron
    Dosage: 120 mcg;qw;sc
    Indication: Hepatitis C
    Start date: 2006-10-10
    End date: 2007-01-01

Ribavirin
    Dosage: 1000 mg;qw;po
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2006-10-10
    End date: 2007-01-01

Oxycodone
    Indication: Drug USE FOR Unknown Indication

Methadone HCL
    Indication: Drug USE FOR Unknown Indication

Other drugs received by patient: Inderal (Con.); Atenolol (Con.); Norvasc (Con.)