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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 gastrointestinal (GI) symptoms of constipation, nausea, stomach pain, loss of appetite, and 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;
- 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
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
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
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 Other CNS Depressants [see WARNINGS AND PRECAUTIONS]
- Hypotensive Effects [see WARNINGS AND PRECAUTIONS]
- Gastrointestinal Effects [see WARNINGS AND PRECAUTIONS]
- Seizures [see WARNINGS AND PRECAUTIONS]
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%)
In clinical trials, the following adverse reactions were reported in patients treated with OXYCONTIN with an incidence between 1% and 5%:
General disorders and administration site conditions: chills, fever
Metabolism and nutrition disorders: anorexia
Musculoskeletal and connective tissue disorders: twitching
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
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
Reproductive system and breast disorders: impotence
Respiratory, thoracic and mediastinal disorders: cough increased, voice alteration
Skin and subcutaneous tissue disorders: dry skin, exfoliative dermatitis
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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