Ultracet Medication Summary
No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication?
This medication is described in FDA/DailyMed prescribing information. No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication used for?
ULTRACET® is indicated for the short-term (five days or less) management of acute pain.
What should I know before taking it?
ULTRACET® should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, acetaminophen, any other component of this product, or opioids. ULTRACET® is contraindicated in any situation where opioids are contraindicated, including acute intoxication with any of the following: alcohol, hypnotics, narcotics, centrally acting analgesics, opioids, or psychotropic drugs. ULTRACET® may worsen central nervous system and respiratory depression in these patients.
What important warnings are listed?
ULTRACET® contains tramadol HCl and acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4,000 milligrams per day, and often involve more than one acetaminophen-containing product (see WARNINGS).
How is this medication usually taken?
For the short-term (five days or less) management of acute pain, the recommended dose of ULTRACET® is 2 tablets every 4 to 6 hours as needed for pain relief, up to a maximum of 8 tablets per day.
What side effects are listed?
Table 2 reports the incidence rate of treatment-emergent adverse events over five days of ULTRACET® use in clinical trials (subjects took an average of at least 6 tablets per day). Body System Preferred Term ULTRACET® (N=142)(%) Gastrointestinal System Disorders Constipation 6 Diarrhea 3 Nausea 3 Dry Mouth 2 Psychiatric Disorders Somnolence 6 Anorexia 3 Insomnia 2 Central & Peripheral Nervous System Dizziness 3 Skin and Appendages Sweating Increased 4 Pruritus 2 Reproductive Disorders, Male Number of males = 62 Prostatic Disorder 2 Incidence at least 1%, causal relationship at least possible or greater: the following lists adverse reactions that occurred with an incidence of at least 1% in.
What interactions are listed?
The FDA/DailyMed label should be reviewed for complete details.
Where can I find the official prescribing information?
Review the full prescribing information on DailyMed: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5d64d06a-1c95-4ec2-97ab-d0b2c57f261f
⚠️ Disclaimer
This summary is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.