Rx-Act Ibuprofen

Ibuprofen is both an over-the-counter and a prescription medication. The over-the-counter form is used both to treat minor aches and pains and also to reduce fever. The prescription form is used for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis, mild to moderate pain, and to treat primary dysmenorrhea. It may also be used to reduce fever in adults. This medication page refers to the prescription form of ibuprofen.

This medication comes in tablet and oral suspension forms. Ibuprofen may be given up to 6 times per day with food or milk to avoid stomach irritation.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Common side effects of ibuprofen include nausea, heartburn, diarrhea, stomach irritation, or headache. Ibuprofen can also cause dizziness. Do not drive or operate heavy machinery until you know how this medication will affect you.

Ibuprofen is a prescription medicine used to treat the symptoms of osteoarthritis, rheumatoid arthritis, primary dysmenorrhea (pain due to menstruation), and mild to moderate pain. It may also be used to reduce fever in adults.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

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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.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• ACE inhibitors such as lisinopril (Zestril, Prinivil), ramipril (Altace), quinapril (Accupril) captopril, benazapril (Lotensin), and enalapril (Vasotec)
• aspirin (Ecotrin)
• diuretics such furosemide (Lasix), hydrochlorothiazide (Microzide), and chlorthalidone (Thalitone)
• lithium
• warfarin (Coumadin, Jantoven)

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

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.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of ibuprofen, there are no specific foods that you must exclude from your diet when receiving ibuprofen.

Before taking ibuprofen, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have kidney problems
• have liver problems
• have heart problems
• have had a stomach bleed or ulcer (hole in the lining of the stomach) in the past
• have asthma
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Ibuprofen falls into category C. This medication may be given to a pregnant woman if her healthcare provider believes that its benefits to the pregnant woman outweigh any possible risks to her unborn baby.

In addition, ibuprofen is known to cause heart defects on the developing fetus. Use during pregnancy, especially during late pregnancy, should be avoided.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if ibuprofen is excreted in human breast milk or if it will harm your nursing baby.

Take ibuprofen exactly as prescribed. Ibuprofen may be taken several times per day, depending on reason for use.

Shake oral suspension ibuprofen before use. May take ibuprofen with food or milk to prevent stomach irritation.

Do not exceed 3.2 grams (3200 mg) per day.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of ibuprofen at the same time unless instructed by your doctor.

Dosing may vary according to type of and severity of condition.

Do not exceed 3.2 grams per day (3200 mg), as this is the recommended maximum dose.

If you take too much ibuprofen, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Store ibuprofen at room temperature.

Keep this and all medicines out of the reach of children.

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.