Roxicet

Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 10/4/2021
Roxicet Side Effects Center

What Is Roxicet?

Roxicet (oxycodone and acetaminophen) is a combination of a narcotic pain reliever and a less potent pain reliever that increases the effects of oxycodone used to relieve moderate to severe pain.

What Are Side Effects of Roxicet?

Common side effects of Roxicet include:

Tell your doctor if you have serious side effects of Roxicet including:

Dosage for Roxicet

The usual adult dosage of Roxicet is one tablet or 5 mL (one teaspoon) of oral solution every 6 hours as needed for pain. The total daily dose of acetaminophen should not exceed 4 grams. Maximum daily dose is 12 tablets, or 12 teaspoons (60 mL).

What Drugs, Substances, or Supplements Interact with Roxicet?

Roxicet may interact with:

  • cold or allergy medicine,
  • sleeping pills,
  • muscle relaxers,
  • medicine for seizures,
  • depression or anxiety medications,
  • glycopyrrolate,
  • mepenzolate,
  • atropine,
  • benztropine,
  • dimenhydrinate,
  • methscopolamine,
  • scopolamine,
  • bladder or urinary medications,
  • bronchodilators, or
  • irritable bowel medications

Tell your doctor all medications you use.

Roxicet During Pregnancy and Breastfeeding

During pregnancy, Roxicet 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 medication 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 you suddenly stop taking this medication.

Additional Information

Our Roxicet (oxycodone and acetaminophen) 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.

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

Medically speaking, the term "myalgia" refers to what type of pain? See Answer
Roxicet Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty 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.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

Call your doctor at once if you have:

  • noisy breathing, sighing, shallow breathing, breathing that stops;
  • a light-headed feeling, like you might pass out;
  • weakness, tiredness, fever, unusual bruising or bleeding;
  • confusion, unusual thoughts or behavior;
  • problems with urination;
  • liver problems--nausea, upper stomach pain, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • 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 include:

  • dizziness, drowsiness, feeling tired;
  • feelings of extreme happiness or sadness;
  • nausea, vomiting, stomach pain;
  • constipation; or
  • headache.

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 Roxicet (Oxycodone and Acetaminophen )

SLIDESHOW

Back Pain: 16 Back Pain Truths and Myths See Slideshow
Roxicet Professional Information

SIDE EFFECTS

Clinical Trials 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 clinical practice.

A total of 1346 subjects were treated with at least one dose of HETLIOZ, of which 139 were treated for > 26 weeks and 93 were treated for > 1 year.

A 26-week, parallel-arm placebo-controlled study (Study 1) evaluated HETLIOZ (n=42) compared to placebo (n=42) in patients with Non-24. A randomized-withdrawal, placebo-controlled study of 8 weeks duration (Study 2) also evaluated HETLIOZ (n=10), compared to placebo (n=10), in patients with Non-24.

In placebo-controlled studies, 6% of patients exposed to HETLIOZ discontinued treatment due to an adverse event, compared with 4% of patients who received placebo.

Table 1 shows the incidence of adverse reactions from Study 1.

Table 1: Adverse Reactions in Study 1

  HETLIOZ
N=42
Placebo
N=42
Headache 17 % 7 %
Alanine aminotransferase increased 10 % 5 %
Nightmare/abnormal dreams 10 % 0 %
Upper respiratory tract infection 7 % 0 %
Urinary tract infection 7 % 2 %
*Adverse reactions with an incidence > 5% and at least twice as high on HETLIOZ than on placebo are displayed.

Read the entire FDA prescribing information for Roxicet (Oxycodone and Acetaminophen )

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

Health Solutions From Our Sponsors