Xartemis XR

Xartemis XR

Xartemis XR Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Xartemis XR (oxycodone hydrochloride and acetaminophen) is a combination of an opioid (narcotic) pain reliever and the analgesic acetaminophen used to manage acute pain severe enough to require opioid treatment and for which alternative treatment options are inadequate. Common side effects include nausea, dizziness, headache, vomiting, constipation, and sleepiness.

The recommended dose of Xartemis XR is 2 tablets every 12 hours administered with or without food. Xartemis XR may interact with other CNS depressants (including sedatives, hypnotics, tranquilizers, general anesthetics, phenothiazines, other opioids, and alcohol), skeletal muscle relaxants, monoamine oxidase inhibitors (MAOIs), certain cardiovascular drugs (including amiodarone and quinidine), antidepressants, CYP3A4 inhibitors, pentazocine, nalbuphine, butorphanol, and buprenorphine, and anticholinergics. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or planning to become pregnant before using Xartemis XR. Using this drug while pregnant or near delivery may cause withdrawal symptoms in your newborn. This drug passes into breast milk and may harm a nursing baby. Breastfeeding is not recommended while using Xartemis XR. Withdrawal symptoms may occur if you suddenly stop taking this medication.

Our Xartemis XR (oxycodone hydrochloride 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.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Xartemis XR FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following treatment-emergent adverse reactions are discussed in more detail in other sections of the labeling:

Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice.

In safety data from two Phase 3 (one placebo-controlled, one open-label) trials where multiple doses of XARTEMIS XR were administered for up to 42 days, the most common adverse reactions (reported by ≥ 10% in any XARTEMIS XR dose group) were: nausea, dizziness and vomiting. The most common reasons for discontinuation due to AEs in these 2 studies (reported by ≥ 1% in any XARTEMIS XR dose group) were vomiting (4.8%) and nausea (4.1%); there were no reports of these adverse reactions in the placebo-treated patients.

A total of 1028 subjects in 14 clinical studies were treated with XARTEMIS XR during the clinical development program, including 892 subjects treated with 15 mg oxycodone and 650 mg acetaminophen. This dosage regimen of XARTEMIS XR was administered to 607 patients in two Phase 3 studies (one placebo-controlled and one open-label).

In a placebo-controlled post-bunionectomy acute pain trial, 329 patients were dosed with 15 mg oxycodone and 650 mg acetaminophen XARTEMIS XR or placebo orally every 12 hours, for approximately 48 hours (blinded period) [see Clinical Studies]. Table 1 lists the adverse reactions reported by ≥ 1% of XARTEMIS XR-treated patients and more frequently in XARTEMIS XR-treated patients compared with placebo.

Table 1: Treatment-Emergent Adverse Reactions* Reported by ≥ 1% of XARTEMIS XR-Treated Patients and More Frequently than Placebo in XARTEMIS XR-Treated Patients with Postoperative Bunionectomy Pain (blinded period)

Preferred Term XARTEMIS XR
(N = 166) %
Placebo
(N = 163) %
Nausea 31 6
Dizziness 13 1
Headache 10 5
Vomiting 9 0
Constipation 4 3
Somnolence 4 < 1
Rash 2 1
Blister 1 < 1
Dysuria 1 0
Edema peripheral 1 0
Erythema 1 0
Excoriation 1 0
Hot flush 1 < 1
Pruritus generalized 1 0
* A treatment-emergent adverse reaction refers to any untoward medical event associated with the use of the drug in humans, whether or not considered drug-related.

Other Adverse Reactions Observed During The Premarketing Evaluation Of XARTEMIS XR

The following adverse drug reactions not listed above occurred in ≥ 1% of XARTEMIS XR-treated patients in the pooled safety data from two Phase 3 studies (including a placebo-controlled and an open-label non-controlled safety study) where multiple-doses of XARTEMIS XR were administered every 12 hours for up to 42 days:

Gastrointestinal disorders: dry mouth, dyspepsia, diarrhea

General disorders and administration site conditions: fatigue Investigations: hepatic enzyme increased

Psychiatric disorders: insomnia

Respiratory, thoracic and mediastinal disorders: cough

The following adverse drug reactions occurred in < 1% of XARTEMIS XR-treated patients in the pooled safety data from the two Phase 3 studies described above:

Cardiac disorders: palpitations

Eye and ear disorders: tinnitus, vision blurred

Gastrointestinal disorders: abdominal discomfort, abdominal pain, esophageal spasm

General disorders and administration site conditions: asthenia, chest discomfort, chills, contusion, fall, feeling jittery, malaise, non-cardiac chest pain, thirst

Immune system disorders: hypersensitivity

Investigations: alanine aminotransferase increased, aspartate aminotransferase increased, blood lactate dehydrogenase increased, blood pressure increased, gamma-glutamyltransferase increased, liver functional test abnormal

Metabolic and nutritional: decreased appetite

Musculoskeletal and connective tissue disorders: arthralgia, musculoskeletal stiffness

Nervous system disorders: cognitive disorder, memory impairment, migraine, myoclonus, paraesthesia, sedation, tremor

Psychiatric disorders: anxiety, confusional state, disorientation, euphoric mood, mood altered, sleep disorder, withdrawal syndrome

Renal and urinary disorders: urine flow decreased

Respiratory, thoracic and mediastinal disorders: dyspnea, hiccups, hypopnea, oropharyngeal pain, throat irritation

Skin and subcutaneous tissue disorders: dermatitis, ecchymosis, hyperhidrosis, urticaria

Vascular disorders: flushing, hypertension

Read the entire FDA prescribing information for Xartemis XR (Oxycodone Hydrochloride and Acetaminophen Extended-Release) »

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Chronic Pain/Back Pain

Find tips and advances in treatment.

Health Resources
advertisement
advertisement
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations