Ibuprofen side effects

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1] Phone:617-525-6884

List of side effects

Cardiovascular thrombosis

Hypertension

Cognitive heart failure and Edema

Gastrointestinal Effects- Risk of Ulceratoin, Bleeding and Perforatoin

Renal effects

Advanced Renal Disease

Anaphylactoid Reactions

Labor & delivery

Skin reactions

Pregnancy

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Cardiovascular thrombosis

Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. All NSAIDs, both COX-2 selective and nonselective, may have a similar risk. Patients with known CV disease or risk factors for CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with an NSAID, the lowest effective dose should be used for the shortest duration possible. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. Patients should be informed about the signs and/or symptoms of serious CV events and the steps to take if they occur. Return to top

Hypertension

NSAIDs, including MOTRIN Suspension, can lead to onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAIDs, including MOTRIN Suspension, should be used with caution in patients with hypertension. Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy. Return to top

Cognitive heart failure and Edema

Fluid retention and edema have been observed in some patients taking NSAIDs. MOTRIN Suspension should be used with caution in patients with fluid retention or heart failure. Return to top

Gastrointestinal Effects- Risk of Ulceratoin, Bleeding and Perforatoin

NSAIDs, including MOTRIN Suspension, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients, who develop a serious upper GI adverse event on NSAAID therapy, is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occur in approximately 1% of patients treated for 3-6 months, and in about 2-4% of patients treated for one year. These trends continue with longer duration of use, increasing the likelihood of developing a serious GI event at some time during the course of therapy. However, even short-term therapy is not without risk. Return to top

Renal effects

Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of a nonsteroidal anti-inflammatory drug may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state. Return to top

Advanced Renal Disease

No information is available from controlled clinical studies regarding the use of MOTRIN Suspension in patients with advanced renal disease. Therefore, treatment with MOTRIN Suspension is not recommended in these patients with advanced renal disease. If MOTRIN Suspension therapy must be initiated, close monitoring of the patient’s renal function is advisable. Return to top

Anaphylactoid Reactions

As with other NSAIDs, anaphylactoid reactions may occur in patients without known prior exposure to MOTRIN Suspension. Motrin Suspension should not be given to patients with the aspirin triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs. Emergency help should be sought in cases where an anaphylactoid reaction occurs. Return to top

Skin reactions

NSAIDs, including MOTRIN Suspension, can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events may occur without warning. Patients should be informed about the signs and symptoms of serious skin manifestations and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity. Return to top

Pregnancy

In late pregnancy, as with other NSAIDs, MOTRIN should be avoided because it may cause premature closure of the ductus arteriosus. Return to top

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The content of this page is taken from the FDA package insert for this drug and should not be edited.