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Roxicodone

Last reviewed on RxList: 10/24/2018
Roxicodone Side Effects Center

Pharmacy Editor: Eni Williams, PharmD

Last reviewed on RxList 10/24/2018

Roxicodone (oxycodone) is an opioid analgesic prescribed to treat moderate to severe pain. Roxicodone is available as a generic drug. The most common side effects of Roxicodone include lightheadedness, dizziness, tiredness, nausea, vomiting, loss of appetite, headache, rash, itching, constipation, dry mouth, and sweating.

The usual starting dose of Roxicodone is 5 to 15 mg every 4 to 6 hours as needed for pain and dose is adjusted based on the patient's response. Drug interactions include alcohol, barbiturates, skeletal muscle relaxants (Soma [carisoprodol] and Flexeril [cyclobenzaprine], benzodiazepines (Ativan [lorazepam]), pentazocine, Nubain (nalbuphine), Stadol (butorphanol), and Subutex (buprenorphine). Roxicodone safety during pregnancy has not been established. Roxicodone is secreted in breast milk and it may have adverse effects on an infant.

Our Roxicodone (oxycodone) 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.

Roxicodone 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.

Like other narcotic medicines, oxycodone can slow your breathing. Death may occur if breathing becomes too weak. A person caring for you should 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;
  • a slow heart rate or weak pulse;
  • a light-headed feeling, like you might pass out;
  • confusion, unusual thoughts or behavior;
  • seizure (convulsions);
  • severe constipation; or
  • low cortisol levels-- nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, confusion, fever, sweating, fast heart rate, chest pain, feeling short of breath, muscle stiffness, trouble walking, or feeling faint.

Serious side effects may be more likely in older adults and those who are malnourished or debilitated.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common side effects may include:

  • drowsiness, headache, dizziness, tired feeling; or
  • constipation, stomach pain, nausea, vomiting, loss of appetite.
  • dry mouth; or
  • mild 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 Roxicodone (Oxycodone Hydrochloride)

Roxicodone Professional Information

SIDE EFFECTS

ROXICODONE (oxycodone hydrochloride) ® tablets have been evaluated in open label clinical trials in patients with cancer and nonmalignant pain. ROXICODONE (oxycodone hydrochloride) ® tablets are associated with adverse experiences similar to those seen with other opioids.

Serious adverse reactions that may be associated with ROXICODONE (oxycodone hydrochloride) ® therapy in clinical use are those observed with other opioid analgesics and include: respiratory depression, respiratory arrest, circulatory depression, cardiac arrest, hypotension, and/or shock (see OVERDOSE, WARNINGS).

The less severe adverse events seen on initiation of therapy with ROXICODONE (oxycodone hydrochloride) ® are also typical opioid side effects. These events are dose dependent, and their frequency depends on the clinical setting, the patient's level of opioid tolerance, and host factors specific to the individual. They should be expected and managed as a part of opioid analgesia. The most frequent of these include nausea, constipation, vomiting, headache, and pruritus.

In many cases the frequency of adverse events during initiation of opioid therapy may be minimized by careful individualization of starting dosage, slow titration and the avoidance of large rapid swings in plasma concentration of the opioid. Many of these adverse events will abate as therapy is continued and some degree of tolerance is developed, but others may be expected to remain throughout therapy.

In all patients for whom dosing information was available (n=191) from the open-label and double-blind studies involving ROXICODONE (oxycodone hydrochloride) ®, the following adverse events were recorded in ROXICODONE (oxycodone hydrochloride) ® treated patients with an incidence ≥ 3%. In descending order of frequency they were: nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia, and somnolence.

The following adverse experiences occurred in less than 3% of patients involved in clinical trials with oxycodone:

Body as a Whole: abdominal pain, accidental injury, allergic reaction, back pain, chills and fever, fever, flu syndrome, infection, neck pain, pain, photosensitivity reaction, and sepsis.

Cardiovascular: deep thrombophlebitis, heart failure, hemorrhage, hypotension, migraine, palpitation, and tachycardia.

Digestive: anorexia, diarrhea, dyspepsia, dysphagia, gingivitis, glossitis, and nausea and vomiting.

Hemic and Lymphatic: anemia and leukopenia.

Metabolic and Nutritional: edema, gout, hyperglycemia, iron deficiency anemia and peripheral edema.

Musculoskeletal: arthralgia, arthritis, bone pain, myalgia and pathological fracture.

Nervous: agitation, anxiety, confusion, dry mouth, hypertonia, hypesthesia, nervousness, neuralgia, personality disorder, tremor, and vasodilation.

Respiratory: bronchitis, cough increased, dyspnea, epistaxis, laryngismus, lung disorder, pharyngitis, rhinitis, and sinusitis.

Skin and Appendages: herpes simplex, rash, sweating, and urticaria.

Special Senses: amblyopia.

Urogenital: urinary tract infection

Drug Abuse And Dependence

Controlled Substance Roxicodone (oxycodone hydrochloride) contains oxycodone, a mu-agonist opioid of the morphine type and is a Schedule II controlled substance. Roxicodone (oxycodone hydrochloride) , like other opioids used in analgesia, can be abused and is subject to criminal diversion.

Abuse

Drug addiction is characterized by compulsive use, use for non-medical purposes, and continued use despite harm or risk of harm. Drug addiction is a treatable disease, utilizing a multi-disciplinary approach, but relapse is common.

“Drug-seeking” behavior is very common in addicts and drug abusers. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated “loss” of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating physician(s). “Doctor shopping” to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction.

Abuse and addiction are separate and distinct from physical dependence and tolerance. Physicians should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence. In addition, abuse of opioids can occur in the absence of true addiction and is characterized by misuse for nonmedical purposes, often in combination with other psychoactive substances. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised.

Roxicodone (oxycodone hydrochloride) is intended for oral use only. Abuse of Roxicodone (oxycodone hydrochloride) poses a risk of overdose and death. The risk is increased with concurrent abuse of alcohol and other substances. Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV.

Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.

Infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal symptoms.

Dependence

Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Physical dependence is manifested by withdrawal symptoms after abrupt discontinuation of a drug or upon administration of an antagonist. Physical dependence and tolerance are not unusual during chronic opioid therapy.

The opioid abstinence or withdrawal syndrome is characterized by some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate. In general, opioids should not be abruptly discontinued.

Read the entire FDA prescribing information for Roxicodone (Oxycodone Hydrochloride)

Related Resources for Roxicodone

Read the Roxicodone User Reviews »

© Roxicodone Patient Information is supplied by Cerner Multum, Inc. and Roxicodone Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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