OXYCONTIN SIDE EFFECTS
- Generic Name: oxycodone hcl
- Brand Name: Oxycontin
- Drug Class: Opioid Agonists
SIDE EFFECTS
The following serious adverse reactions are described elsewhere in the labeling:
- Addiction, Abuse, and Misuse
- Life-Threatening Respiratory Depression
- Neonatal Opioid Withdrawal Syndrome
- Interactions With Benzodiazepines and Other CNS Depressants
- Adrenal Insufficiency
- Severe Hypotension
- Gastrointestinal Adverse Reactions
- Seizures
- Withdrawal
Clinical Trial Experience
Adult Clinical Trial 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.
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.
OXYCONTIN may increase the risk of serious adverse reactions such as those observed with other opioid analgesics, including respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, or shock.
The most common adverse reactions (>5%) reported by patients in clinical trials comparing OXYCONTIN with placebo are shown in Table 1 below:
TABLE 1: Common Adverse Reactions (>5%)
Adverse Reaction | OXYCONTIN (n=227)(%) |
Placebo (n=45)(%) |
Constipation | (23) | (7) |
Nausea | (23) | (11) |
Somnolence | (23) | (4) |
Dizziness | (13) | (9) |
Pruritus | (13) | (2) |
Vomiting | (12) | (7) |
Headache | (7) | (7) |
Dry Mouth | (6) | (2) |
Asthenia | (6) | – |
Sweating | (5) | (2) |
In clinical trials, the following adverse reactions were reported in patients treated with OXYCONTIN with an incidence between 1% and 5%:
Gastrointestinal disorders: abdominal pain, diarrhea, dyspepsia, gastritis
General disorders and administration site conditions: chills, fever
Metabolism and nutrition disorders: anorexia
Musculoskeletal and connective tissue disorders: twitching
Psychiatric disorders: abnormal dreams, anxiety, confusion, dysphoria, euphoria, insomnia, nervousness, thought abnormalities
Respiratory, thoracic and mediastinal disorders: dyspnea, hiccups
Skin and subcutaneous tissue disorders: rash
Vascular disorders: postural hypotension
The following adverse reactions occurred in less than 1% of patients involved in clinical trials:
Blood and lymphatic system disorders: lymphadenopathy
Ear and labyrinth disorders: tinnitus
Eye disorders: abnormal vision
Gastrointestinal disorders: dysphagia, eructation, flatulence, gastrointestinal disorder, increased appetite, stomatitis
General disorders and administration site conditions: withdrawal syndrome (with and without seizures), edema, peripheral edema, thirst, malaise, chest pain, facial edema
Injury, poisoning and procedural complications: accidental injury
Investigations: ST depression
Metabolism and nutrition disorders: dehydration
Nervous system disorders: syncope, migraine, abnormal gait, amnesia, hyperkinesia, hypoesthesia, hypotonia, paresthesia, speech disorder, stupor, tremor, vertigo, taste perversion
Psychiatric disorders: depression, agitation, depersonalization, emotional lability, hallucination
Renal and urinary disorders: dysuria, hematuria, polyuria, urinary retention
Reproductive system and breast disorders: impotence
Respiratory, thoracic and mediastinal disorders: cough increased, voice alteration
Skin and subcutaneous tissue disorders: dry skin, exfoliative dermatitis
Clinical Trial Experience In Pediatric Patients 11 Years And Older
The safety of OXYCONTIN has been evaluated in one clinical trial with 140 patients 11 to 16 years of age. The median duration of treatment was approximately three weeks. The most frequently reported adverse events were vomiting, nausea, headache, pyrexia, and constipation.
Table 2 includes a summary of the incidence of treatment emergent adverse events reported in ≥5% of patients.
Table 2: Incidence of Adverse Reactions Reported in ≥ 5.0% Patients 11 to 16 Years
System Organ Class Preferred Term |
11 to 16 Years (N=140) n (%) |
Any Adverse Event >= 5% | 71 (51) |
GASTROINTESTINAL DISORDERS | 56 (40) |
Vomiting | 30 (21) |
Nausea | 21 (15) |
Constipation | 13 (9) |
Diarrhea | 8 (6) |
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | 32 (23) |
Pyrexia | 15 (11) |
METABOLISM AND NUTRITION DISORDERS | 9 (6) |
Decreased appetite | 7 (5) |
NERVOUS SYSTEM DISORDERS | 37 (26) |
Headache | 20 (14) |
Dizziness | 12 (9) |
SKIN AND SUBCUTANEOUS TISSUE DISORDERS | 23 (16) |
Pruritus | 8 (6) |
The following adverse reactions occurred in a clinical trial of OXYCONTIN in patients 11 to 16 years of age with an incidence between ≥1.0% and < 5.0%. Events are listed within each System/Organ Class.
Blood and lymphatic system disorders: febrile neutropenia, neutropenia
Cardiac disorders: tachycardia
Gastrointestinal disorders: abdominal pain, gastroesophageal reflux disease
General disorders and administration site conditions: fatigue, pain, chills, asthenia
Injury, poisoning, and procedural complications: procedural pain, seroma
Investigations: oxygen saturation decreased, alanine aminotransferase increased, hemoglobin decreased, platelet count decreased, neutrophil count decreased, red blood cell count decreased, weight decreased
Metabolic and nutrition disorders: hypochloremia, hyponatremia
Musculoskeletal and connective tissue disorders: pain in extremity, musculoskeletal pain
Nervous system disorders: somnolence, hypoesthesia, lethargy, paresthesia
Psychiatric disorders: insomnia, anxiety, depression, agitation
Renal and urinary disorders: dysuria, urinary retention
Respiratory, thoracic, and mediastinal disorders: oropharyngeal pain
Skin and subcutaneous tissue disorders: hyperhidrosis, rash
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of extended-release 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.
Abuse, addiction, aggression, amenorrhea, cholestasis, completed suicide, death, dental caries, increased hepatic enzymes, hyperalgesia, hypogonadism, hyponatremia, ileus, intentional overdose, mood altered, muscular hypertonia, overdose, palpitations (in the context of withdrawal), seizures, suicidal attempt, suicidal ideation, syndrome of inappropriate antidiuretic hormone secretion, and urticaria.
In addition to the events listed above, the following have also been reported, potentially due to the swelling and hydrogelling property of the tablet: choking, gagging, regurgitation, tablets stuck in the throat and difficulty swallowing the tablet.
Serotonin syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.
Adrenal insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.
Anaphylaxis: Anaphylaxis has been reported with ingredients contained in OXYCONTIN.
Androgen deficiency: Cases of androgen deficiency have occurred with chronic use of opioids.
SRC: NLM .