"The the European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) will review the risks and benefits of modified- and prolonged-release paracetamol (acetaminophen) tablets, the agency said today.
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 of Xartemis XR include nausea, dizziness, headache, vomiting, constipation, sleepiness, rash, blisters, difficulty urinating, swelling of the hands or feet, redness, skin picking, hot flashes, flushing, and itching.
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
The following treatment-emergent adverse reactions are discussed in more detail in other sections of the labeling:
- Respiratory Depression [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, and OVERDOSAGE]
- Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
- Use With Other Acetaminophen-containing Products [see WARNINGS AND PRECAUTIONS]
- Interactions with Other CNS Depressants [see WARNINGS AND PRECAUTIONS]
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 XRtreated 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
|Preferred Term||XARTEMIS XR
(N = 166)%
(N = 163)%
|Hot flush||1||< 1|
|*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:
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
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
Psychiatric disorders: anxiety, confusional state, disorientation, euphoric mood, mood altered, sleep disorder, withdrawal syndrome
Renal and urinary disorders: urine flow decreased
Vascular disorders: flushing, hypertension
Read the entire FDA prescribing information for Xartemis XR (Oxycodone Hydrochloride and Acetaminophen Extended-Release)
Additional Xartemis XR Information
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.
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