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Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
• Visiting the Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Serious Warnings and Precautions

If you have, or previously had, any of the following medical conditions, see your health care provider to discuss treatment options other than Combogesic®:

  • Heart attack or angina
  • Stroke or mini-stroke
  • Loss of vision
  • Current pregnancy (less than 28 weeks)
  • Congestive Heart Failure

Combogesic® may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal.

Combogesic® is contraindicated for treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.

Stomach bleeding warning: This product may cause stomach bleeding. Symptoms may include feeling faint, vomiting blood, bloody or black stools. The chance of stomach bleeding is higher if you:

  • are aged 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinner or steroid drug
  • take with other drugs containing an NSAID like acetylsalicylic acid (ASA), ibuprofen, naproxen, or prescription anti-inflammatory drugs
  • have 3 or more alcoholic drinks every day while using this product

Talk to your doctor if you are trying to conceive, in your first or second trimester of pregnancy or if breastfeeding. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless directed by a doctor because it may cause problems in the unborn child or complications during delivery.

Liver warning: Combogesic® contains acetaminophen, which 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 doses of acetaminophen that exceed 4,000 milligrams per day.

Severe or possibly fatal liver damage may occur if you take:

  • more than the recommended dose in 24 hours
  • with other drugs containing acetaminophen
  • while drinking three (3) or more alcoholic drinks every day.

Symptoms of liver damage may include yellowing of the skin/eyes, dark urine, nausea, vomiting, stomach pain, unusual tiredness, and/or loss of appetite.

Allergy alert: Acetaminophen may cause serious skin reactions. Symptoms may include skin reddening, blisters, or rash. If any of the above noted symptoms occur, stop use and seek medical help right away.

View Product Monograph here

*These claims are based on the maximum 3 tablet dose. The standard dose is 1-2 tablets – 3 if advised by your doctor.

1. Daniels SE, Atkinson HC, Stanescu I, Frampton C. Analgesic efficacy of an acetaminophen/ibuprofen fixed-dose combination in moderate to severe postoperative dental pain: a randomized, double-blind, parallel-group, placebo-controlled trial. Clin Ther. 2018;40(10):1765–1776.