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OxyContin

Last reviewed on RxList: 1/6/2017
OxyContin Side Effects Center

Last reviewed on RxList 8/30/2016

Oxycontin (oxycodone hydrochloride) is an opioid drug used for the management of moderate to severe pain, usually for an extended time period. Oxycontin is not an "as needed for pain (PRN) drug." Oxycontin is available as a generic drug. Common side effects of Oxycontin include

Tell your doctor if you experience serious side effects of Oxycontin including

Oxycontin (oxycodone hydrochloride) is available as controlled-release tablets in strengths of 10, 15, 20, 30, 40, 60, 80, and 160 mg tablets (60 mg and above used only for opioid tolerant patients). The tablets must be swallowed whole because broken or chewed tablets release the drug too rapidly and because Oxycontin is rapidly adsorbed, too concentrated levels will be present in the body which can lead to death. Oxycontin may interact with other narcotic pain medications, sedatives, tranquilizers, sleeping pills, muscle relaxers, other medicines that can make you sleepy or slow your breathing, pentazocine, nalbuphine, butorphanol, or buprenorphine. Tell your doctor all medications and supplements you use. This opioid is often the drug of choice for addictive use and can easily lead to dependency. Some patients may develop tolerance for Oxycontin and need to be slowly weaned off the drug. Safety has not been established in children under age 18; caution or avoidance is suggested in pregnant and breastfeeding women as infants can be born with opioid tolerance and depressed respirations. In addition, low concentrations of Oxycontin have been found in breast milk.

Our Oxycontin Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

OxyContin Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using oxycodone and call your doctor at once if you have:

  • shallow breathing, slow heartbeat;
  • seizure (convulsions);
  • cold, clammy skin;
  • confusion;
  • severe weakness or dizziness; or
  • a feeling like you might pass out.

Common side effects may include:

  • nausea, vomiting, constipation, loss of appetite;
  • dizziness, headache, tired feeling;
  • dry mouth;
  • sweating; or
  • itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for OxyContin (Oxycodone HCl)

OxyContin Professional Information

SIDE EFFECTS

The following serious adverse reactions are described elsewhere in the labeling:

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 [see OVERDOSAGE].

The most common adverse reactions ( > 5%) reported by patients in clinical trials comparing OXYCONTIN with placebo are shown in Table 2 below:

TABLE 2: 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) -
Swe ating (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 les s 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 3 includes a summary of the incidence of treatment emergent adverse events reported in ≥ 5% of patients.

Table 3: 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)
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, hyponatraemia

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 controlled-release oxycodone: 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.

Anaphylaxis has been reported with ingredients contained in OXYCONTIN. Advise patients how to recognize such a reaction and when to seek medical attention.

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.

Read the entire FDA prescribing information for OxyContin (Oxycodone HCl)

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