Less Pain1-5 Less Opioids2,3 Improved Patient Satisfaction2,4


  1. Bektas F et al. Ann Emerg Med. 2009;54(4):568-574.
  2. Sinatra RS et al. Anesthesiology. 2005;102(4):822-831.
  3. Arici S et al. Ağri. 2009;21(2):54-61.
  4. Wininger SJ et al. Clin Ther. 2010;32(14):2348-2369.
  5. Sinatra RS et al. Pain Pract. 2012;12(5):357-365.
  6. Kett DH et al. Clin Pharmacol Ther. 2011;90(1):32-39.
  7. Warfield CA et al. Anesthesiology. 1995;83(5):1090-1094.
  8. Gan TJ et al. Curr Med Res Opin. 2014;30(1):149-160.
  9. Gottschalk A et al. Am Fam Physician. 2001;63(10):1979-1984.
  10. Anderson BJ. Pediatr Anesth. 2008;18(10):915-921.
  11. De Kock MF et al. Best Pract Res Clin Anaesthesiol. 2007;21(1):85-98.
  12. Kehlet H et al. Anesth Analg. 1993;77(5):1048-1056.
  13. Joshi GP. Anesthesiol Clin North America. 2005;23(1):185-202.
  14. The Joint Commission. Sentinel Event Alert. 2012;49:1-5. http://www.jointcommission.org/assets/1/18/SEA_49_opioids_8_2_12_final.pdf. Accessed March 9, 2017.
  15. American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012;116(2):248-273.
  16. Crews JC. JAMA. 2002;288(5):629-632.
  17. Manworren RCB. AORN J. 2015;101(3):308-314.
  18. Wells N et al. Improving the quality of care through pain assessment and management. In: Hughes RG, ed. Patient Safety and Quality: An Evidence-Based Handbook for Nurses. Rockville, MD: Agency for Healthcare Research and Quality; 2008:chap 17.
  19. American Academy of Orthopaedic Surgeons Work Group. Management of hip fractures in the elderly: evidence-based clinical practice guideline. http://www.aaos.org/Research/guidelines/HipFxGuideline_rev.pdf. Published September 5, 2014. Accessed March 9, 2017.
  20. Mohanty S et al. Optimal perioperative management of the geriatric patient: a best practices guideline from the ACS NSQIP/American Geriatrics Society. https://www.facs.org/~/media/files/quality%20programs/geriatric/acs%20nsqip%20geriatric%202016%20guidelines.ashx. Accessed March 9, 2017.
  21. Shah S et al; The American Geriatrics Society. Pain management in the elderly. http://www.americangeriatrics.org/gsr/anesthesiology/pain_management.pdf. Accessed March 9, 2017.
  22. Antman EM et al. Circulation. 2007;115(12):1634-1642.
  23. Jarzyna D et al. Pain Manag Nurs. 2011;12(3):118-145.
  24. American Society of PeriAnesthesia Nurses. J Perianesth Nurs. 2003;18(4):232-236.
  25. Gustafsson UO et al. World J Surg. 2013;37:259-284.
  26. Barr J et al. Crit Care Med. 2013;41(1):263-306.
  27. Frederickson TW et al, eds. Reducing Adverse Drug Events Related to Opioids Implementation Guide. Philadelphia, PA: Society of Hospital Medicine; 2015.
  28. Petring OU et al. Br J Anaesth. 1995;74(3):257-260.
  29. Berger MM et al. Crit Care Med. 2000;28(7):2217-2223.
  30. Petring OU et al. Anaesth Intensive Care. 1993;21(6):774-781.
  31. Behm B et al. Clin Gastroenterol Hepatol. 2003;1(2):71-80.
  32. Devarakonda K et al. Morphine impacts the absorption of co-administered oral acetaminophen and results in altered pharmacokinetics in healthy subjects. Poster presented at: American Society of Regional Anesthesia Annual Meeting; November 17-19, 2016; San Diego, CA.
  33. Data on file. Mallinckrodt Hospital Products, Inc.
  34. OFIRMEV [package insert]. Hazelwood, MO: Mallinckrodt Hospital Products, Inc; 2017.
  35. Singla NK et al. Pain Pract. 2012;12(7):523-532.
Scroll down for additional important safety information

Indications and Usage

OFIRMEV® (acetaminophen) injection is indicated for the management of mild to moderate pain in adult and pediatric patients 2 years and older, the management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older, and the reduction of fever in adult and pediatric patients.

Important Safety Information


Take care when prescribing, preparing, and administering OFIRMEV® (acetaminophen) injection to avoid dosing errors which could result in accidental overdose and death. In particular, be careful to ensure that:

  • the dose in milligrams (mg) and milliliters (mL) is not confused;
  • the dosing is based on weight for patients under 50 kg;
  • infusion pumps are properly programmed; and
  • the total daily dose of acetaminophen from all sources does not exceed maximum daily limits.

OFIRMEV contains 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 the recommended maximum daily limits, and often involve more than one acetaminophen-containing product.


  • Acetaminophen is contraindicated in patients with
    • known hypersensitivity to acetaminophen or to any of the excipients in the intravenous formulation.
    • severe hepatic impairment or severe active liver disease.

Warnings and Precautions

  • Administration of acetaminophen in doses higher than recommended may result in hepatic injury, including the risk of liver failure and death. Do not exceed the maximum recommended daily dose of acetaminophen. The maximum recommended daily dose of acetaminophen includes all routes of acetaminophen administration and all acetaminophen-containing products administered, including combination products. Dosing errors could result in accidental overdose and death.
  • Use caution when administering acetaminophen in patients with the following conditions: hepatic impairment or active hepatic disease, alcoholism, chronic malnutrition, severe hypovolemia, or severe renal impairment (creatinine clearance ≤ 30 mL/min).
  • Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Discontinue OFIRMEV immediately at the first sign of skin rash.
  • Take care when prescribing, preparing, and administering OFIRMEV Injection to avoid dosing errors, which could result in accidental overdose and death.
  • Hypersensitivity and anaphylaxis associated with the use of acetaminophen have been reported. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, and pruritus. Discontinue OFIRMEV immediately upon occurrence of signs or symptoms associated with allergy or hypersensitivity. Do not use OFIRMEV in patients with acetaminophen allergy.
  • The antipyretic effects of OFIRMEV may mask fever.

Adverse Reactions

  • Serious adverse reactions may include hepatic injury, serious skin reactions, allergy, and hypersensitivity.
  • The most common adverse reactions in patients treated with OFIRMEV were nausea, vomiting, headache, and insomnia in adult patients and nausea, vomiting, constipation, and pruritus in pediatric patients.

To report SUSPECTED ADVERSE REACTIONS, contact Mallinckrodt Hospital Products, Inc. at 1-800-778-7898 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see additional Important Safety Information, including Boxed Warning, in the Full Prescribing Information.