Applies to acetaminophen / ibuprofen: oral tablet.
Oral route (Tablet)
Warning: Hepatotoxicity, Cardiovascular Risk, and Gastrointestinal RiskHepatotoxicityAcetaminophen / ibuprofen 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 4000 milligrams per day, and often involve more than one acetaminophen-containing product.Cardiovascular RiskAcetaminophen / ibuprofen contains ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID). NSAIDs cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction, and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.Acetaminophen / ibuprofen is contraindicated for treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.Gastrointestinal RiskNSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.
Serious side effects
Along with its needed effects, acetaminophen / ibuprofen may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking acetaminophen / ibuprofen:
Incidence not known
- Agitation
- blistering, peeling, loosening of the skin
- blood in the urine
- bloody or black, tarry stools
- blurred vision
- changes in vision, especially night blindness
- chest pain, discomfort, or tightness
- chills
- coma
- confusion
- constipation
- cough
- cracks in the skin
- dark urine
- decreased urine output
- depression
- difficulty in speaking
- difficulty swallowing
- dilated neck veins
- dizziness
- double vision
- fast heartbeat
- fever
- glare or snowy image caused by bright light
- headache
- heartburn
- hives, itching, skin rash
- inability to move the arms, legs, or facial muscles
- inability to speak
- indigestion
- irritability
- joint or muscle pain
- lethargy
- loss of appetite
- loss of heat from the body
- muscle twitching
- nausea or vomiting
- numbness or tingling in hands, feet, or lips
- nervousness
- pain or discomfort in the arms, jaw, back, or neck
- painful or difficult urination
- pale skin
- pounding in the ears
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red, swollen skin
- red irritated eyes
- red skin lesions, often with a purple center
- scaly skin
- seizures
- slow or fast heartbeat
- slow speech
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- stiff neck or back
- stomach pain, cramping, or burning
- stupor
- sweating
- swelling of the face, fingers, feet, or lower legs
- swollen glands
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting of blood or material that looks like coffee grounds
- weakness or heaviness of legs
- weight gain
Other side effects
Some side effects of acetaminophen / ibuprofen may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
- Trouble sleeping
Rare
- Acid or sour stomach
- belching
- stomach discomfort or upset
