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OxyContin

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Oxycontin

OxyContin Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Oxycontin (oxycodone hydrochloride) is an opioid drug used for the management of moderate to severe pain, usually for an extended time period; it is not an "as needed for pain (PRN) drug." Oxycontin is available as a generic drug named oxycodone hydrochloride. The most frequent minor side effects of Oxycontin include GI symptoms of constipation, nausea, vomiting, and other symptoms including somnolence (sleepiness), dizziness, itching, headache, dry mouth, sweating, and decreases in the ability to feel pain.

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. Serious adverse reactions which may occur with Oxycontin are similar to those observed with other opioid analgesics; they include respiratory depression, apnea (stopped breathing), respiratory arrest, circulatory depression, hypotension (low blood pressure), shock, and death. 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

OxyContin in Detail - Patient Information: Side Effects

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

OxyContin Overview - Patient Information: Side Effects

SIDE EFFECTS: Nausea, vomiting, constipation, dry mouth, weakness, sweating, lightheadedness, dizziness, or drowsiness may occur. Some of these side effects may decrease after you have been using this medication for a while. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. Ask your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

You may notice an empty tablet shell in your stool. This is harmless because your body has already absorbed the medicine.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (such as agitation, confusion, hallucinations), severe stomach/abdominal pain, difficulty urinating.

Seek immediate medical attention if any of these rare but serious side effects occur: fainting, seizure, slow/shallow breathing, unusual drowsiness/difficulty waking up.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for OxyContin (Oxycodone HCl)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

OxyContin FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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

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 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, hypesthesia, 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

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of controlled-release oxycodone: abuse, addiction, amenorrhea, cholestasis, death, dental caries, increased hepatic enzymes, hyperalgesia, hypogonadism, hyponatremia, ileus, muscular hypertonia, overdose, palpitations (in the context of withdrawal), seizures, 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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Oxycontin - User Reviews

Oxycontin User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Oxycontin sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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