Uni-Pro

Serious side effects have been reported with ibuprofen. See “Drug Precautions” section.

Common side effects of ibuprofen include:

• stomach effects:  nausea, heartburn, diarrhea, stomach irritation, bloating or flatulence, constipation
• others: headache, dizziness, ringing in the ears, swelling of arms or legs, rash

This is not a complete list of ibuprofen side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Serious side effects have been reported with ibuprofen including:

• Heart attack or stroke: Tell your healthcare provider right away if you have some or all of the following symptoms of...
  • shortness of breath
  • chest pain
  • weakness
  • slurring of speech
• Hypertension: new hypertension or worsening of preexisting hypertension
  • Have your blood pressure monitored by your doctor closely if taking ibuprofen, especially if you have a history of hypertension or are taking medications to treat hypertension
• Congestive heart failure (CHF): Tell your doctor if you...
  • have or have had CHF diagnosed in the past
  • note signs of CHF, such as swelling in the arms or legs, shortness of breath, unexplained weight gain, or fatigue
• Serious and sometimes fatal skin reaction: Tell your healthcare provider right away if you have some or all of the following symptoms of...
  • rash
  • blistering
  • itching
  • fever
• Stomach bleeding, and/or ulceration: Tell your healthcare provider right away if you have some or all of the following symptoms of...
  • pain
  • blood in stools (black or tarry stools)
  • coughing up of blood
  • indigestion or general stomach discomfort
• Liver toxicity: Tell your healthcare provider right away if you have some or all of the following...
  • flu-like symptoms
  • fatigue
  • nausea
  • yellow tinting of the skin or eyes
• Kidney injury: Patients at greatest risk of this reaction include those with preexisting renal dysfunction, heart failure,liver injury, those taking diuretics or ACE inhibitors, and the elderly. Ibuprofen is not recommended in these patients with advanced renal disease.
• Anaphylactoid reaction: Tell your healthcare provider right away if you have some or all of the following symptoms...
  • swelling of the face or throat
  • difficulty of breathing
• Changes in vision: Tell your healthcare provider right away if you have some or all of the following symptoms...
  • blurred or decreased vision
  • changes in color vision
  • dark or gray spots in field of vision
• Pregnancy: In late pregnancy, ibuprofen should be avoided since it may cause premature closure of the ductus arteriosus.

Do not take ibuprofen if the following has occurred:

• an allergic reaction to ibuprofen
• asthma, hives, or other allergic-type reactions after taking aspirin or other NSAIDs
• coronary artery bypass graft (CABG) surgery; ibuprofen is not to be used for treating pain before or after this surgery

Ibuprofen can cause dizziness. Do not drive or operate heavy machinery until you know how Ibuprofen affects you.

Cardiovascular Risk:

• NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
• These drugs are contraindicated for treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Risk:

• NSAIDs 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 are at greater risk for serious gastrointestinal events.