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Roxicodone 15, 30 mg

Last reviewed on RxList: 9/12/2016
Roxicodone 15 30 mg Side Effects Center

Last reviewed on RxList 5/22/2015

Roxicodone (oxycodone hydrochloride) is a narcotic pain reliever used to treat moderate to severe pain. The extended-release form of Roxicodone is for around-the-clock treatment of pain. Roxicodone is available in generic form. Common side effects of Roxicodone include:

Tell your doctor if you experience unlikely but serious side effects of Roxicodone including mental/mood changes (such as agitation, confusion, hallucinations), severe stomach/abdominal pain, or difficulty urinating.

The starting dose of Roxicodone for patients who have not been receiving opioid analgesics is a range of 5 to 15 mg every 4 to 6 hours as needed for pain. Roxicodone may interact with alcohol, other narcotic pain medications, sedatives, tranquilizers, muscle relaxers, other medicines that can make you sleepy or slow your breathing, pentazocine, nalbuphine, butorphanol, or buprenorphine. Tell your doctor all medications you use. During pregnancy, Roxicodone should be used only when prescribed. Using it near the expected delivery date is not recommended because of the potential for harm to the fetus. Babies born to mothers who have used this medication may have withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, or diarrhea. If you notice symptoms in your newborn, tell the doctor. This drug passes into breast milk and may rarely have undesirable effects on a nursing infant. Tell the doctor if your baby develops unusual sleepiness, difficulty feeding, or trouble breathing. Consult your doctor before breastfeeding. Withdrawal symptoms may occur if this drug is abruptly stopped.

Our Roxicodone (oxycodone hydrochloride) 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 15 30 mg 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 Roxicodone 15 30 mg (Oxycodone Hydrochloride )

Roxicodone 15 30 mg Professional Information

SIDE EFFECTS

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

Serious adverse reactions that may be associated with ROXICODONE® 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® 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® , the following adverse events were recorded in ROXICODONE® 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.

Postmarketing Experience

Review of postmarketing reports showed the occurrence of the following adverse events:

Cardiac disorders: myocardial ischemia and ventricular fibrillation with overdose

General disorders and administrative site disorders: drug withdrawal syndrome neonatal

Immune system disorders: anaphylactic reactions

Respiratory, thoracic and mediastinal disorders: pharyngeal edema

Read the entire FDA prescribing information for Roxicodone 15 30 mg (Oxycodone Hydrochloride )

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