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OxyContin

Oxycontin (Oxycodone HCl) side effects drug center

 

PROFESSIONAL

CONSUMER

SIDE EFFECTS

 

OxyContin Side Effects Center

What Is OxyContin?

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.

What Are Side Effects of OxyContin?

Common side effects of Oxycontin include

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

Dosage for OxyContin

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.

What Drugs, Substances, or Supplements Interact with OxyContin?

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.

OxyContin During Pregnancy and Breastfeeding

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.

Additional Information

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

 

OxyContin Consumer Information

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

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once if you have:

  • noisy breathing, sighing, shallow breathing, breathing that stops during sleep;
  • a slow heart rate or weak pulse;
  • a light-headed feeling, like you might pass out;
  • confusion, unusual thoughts or behavior;
  • seizure (convulsions);
  • low cortisol levels-- nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or
  • high levels of serotonin in the body--agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea.

Serious breathing problems may be more likely in older adults and in those who are debilitated or have wasting syndrome or chronic breathing disorders.

Common side effects may include:

  • drowsiness, headache, dizziness, tiredness; or
  • constipation, stomach pain, nausea, vomiting.

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:

  • Addiction, Abuse, and Misuse [see WARNINGS AND PRECAUTIONS]
  • Life-Threatening Respiratory Depression [see WARNINGS AND PRECAUTIONS]
  • Neonatal Opioid Withdrawal Syndrome [see WARNINGS AND PRECAUTIONS]
  • Interactions With Benzodiazepines and Other CNS Depressants [see WARNINGS AND PRECAUTIONS]
  • Adrenal Insufficiency [see WARNINGS AND PRECAUTIONS]
  • Severe Hypotension [see WARNINGS AND PRECAUTIONS]
  • Gastrointestinal Adverse Reactions [see WARNINGS AND PRECAUTIONS]
  • Seizures [see WARNINGS AND PRECAUTIONS]
  • Withdrawal [see WARNINGS AND PRECAUTIONS]

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 OVERDOSE].

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) -
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 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)
  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 extendedrelease 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 [see CLINICAL PHARMACOLOGY].

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

&Copy; OxyContin Patient Information is supplied by Cerner Multum, Inc. and OxyContin Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.