Oxecta Side Effects Center

Last updated on RxList: 9/29/2022
Oxecta Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Oxecta?

Oxecta (oxycodone HCl) is indicated for the management of acute and chronic moderate to severe pain.

What Are Side Effects of Oxecta?

Oxecta may cause serious side effects including:

  • hives,
  • difficulty breathing,
  • swelling of your face, lips, tongue, or throat,
  • slow breathing with long pauses,
  • blue colored lips,
  • difficult to wake up,
  • noisy breathing,
  • sighing,
  • shallow breathing,
  • breathing that stops during sleep,
  • slow heart rate,
  • weak pulse,
  • lightheadedness,
  • confusion,
  • unusual thoughts or behavior,
  • seizure,
  • nausea,
  • vomiting,
  • loss of appetite,
  • dizziness,
  • worsening tiredness or weakness,
  • agitation,
  • hallucinations,
  • fever,
  • sweating,
  • shivering,
  • fast heart rate,
  • muscle stiffness,
  • twitching,
  • loss of coordination, and
  • diarrhea

Get medical help right away, if you have any of the symptoms listed above.

Common side effects of Oxecta include:

  • abdominal pain,
  • nausea,
  • vomiting,
  • constipation,
  • lightheadedness,
  • dizziness,
  • drowsiness,
  • low blood pressure,
  • weakness,
  • itching,
  • accidental injury,
  • allergic reaction,
  • back pain,
  • chills,
  • fever,
  • flu syndrome,
  • infection,
  • neck pain,
  • sensitivity to sunlight, and
  • severe infection (sepsis).

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Oxecta

The dose of Oxecta is individually adjusted according to severity of pain, and the patient's response, weight, age, and prior analgesic treatment experience.

What Drugs, Substances, or Supplements Interact with Oxecta?

Oxecta may interact with:


Tell your doctor all medications and supplements you use.

Oxecta During Pregnancy or Breastfeeding

Tell your doctor if you are pregnant or become pregnant before using Oxecta. Newborns whose mothers have taken oxycodone chronically may exhibit respiratory depression and/or withdrawal symptoms, either at birth and/or in the nursery. Oxecta passes into breast milk and may cause adverse reactions in a nursing infant. Breastfeeding while using Oxecta is not recommended.

Additional Information

Our Oxecta 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.

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Oxecta 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.

QUESTION

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Oxecta Professional Information

SIDE EFFECTS

Clinical Studies

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in 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 clinical practice.

Serious adverse reactions that may be associated with OXECTA include: respiratory depression, respiratory arrest, circulatory depression, cardiac arrest, hypotension, and/or shock [see WARNINGS AND PRECAUTIONS and OVERDOSAGE].

The common adverse reactions seen on initiation of therapy with OXECTA 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 therapy. The most frequent of the adverse reactions include nausea, constipation, vomiting, headache, and pruritus.

The frequency of adverse reactions 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 reactions 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 open-label and double-blind studies involving oxycodone, the following adverse reactions were recorded in oxycodone-treated patients with an incidence of ≥ 3%. In descending order of frequency they were: nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia, and somnolence.

The following adverse reactions 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 vein thrombophlebitis, heart failure, hemorrhage, hypotension, migraine, palpitation, and tachycardia.

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

Hematopoietic and Lymphatic: anemia and leukopenia.

Metabolism and Nutrition: edema, gout, hyperglycemia, iron deficiency anemia, and peripheral edema.

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

Nervous System: 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.

Read the entire FDA prescribing information for Oxecta (Oxycodone HCl, USP Tablets)

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

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