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Caldolor

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Caldolor

PATIENT INFORMATION

Patients should be informed of the following information before initiating therapy with an NSAID.

Cardiovascular Effects

Ibuprofen, like other NSAIDs, may cause serious CV events such as myocardial infarction or stroke, which may result in hospitalization and even death. Although serious CV events can occur without warning symptoms, advise patients to be alert for the signs and symptoms of chest pain, shortness of breath, weakness, and slurring of speech, and to ask for medical advice when observing any indicative sign or symptoms. Inform patients of the importance of this follow-up [see WARNINGS AND PRECAUTIONS].

Gastrointestinal Effects

Ibuprofen, like other NSAIDs, can cause GI discomfort and, rarely, serious GI side effects such as ulcers and bleeding, which may result in hospitalization and even death. Although serious GI tract ulcerations and bleeding can occur without warning symptoms, advise patients to be alert for the signs and symptoms of ulcerations and bleeding, and to ask for medical advice when observing any indicative signs or symptoms including epigastric pain, dyspepsia, melena, and hematemesis. Inform patients of the importance of this follow-up [see WARNINGS AND PRECAUTIONS].

Hepatotoxicity

Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, and “flulike” symptoms). Instruct patients to stop therapy with Caldolor and seek immediate medical therapy if any of these occur [see WARNINGS AND PRECAUTIONS].

Adverse Skin Reactions

Ibuprofen, like other NSAIDs, can cause serious skin side effects such as exfoliative dermatitis, SJS and TEN, which may result in hospitalization and even death. Although serious skin reactions may occur without warning, advise patients to be alert for the signs and symptoms of skin rash and blisters, fever, or other signs of hypersensitivity such as itching, and to ask for medical advice when observing any indicative sign or symptoms. Advise patients to stop Caldolor immediately if they develop any type of rash, and to contact a physician as soon as possible [see WARNINGS AND PRECAUTIONS].

Weight Gain And Edema

Advise patients to promptly report to their physicians signs or symptoms of unexplained weight gain or edema during treatment with Caldolor [see WARNINGS AND PRECAUTIONS].

Anaphylactoid Reactions

Inform patients of the signs of an anaphylactoid reaction (e.g. difficulty in breathing, swelling of the face or throat). If these occur, therapy should be discontinued and medical therapy initiated [see WARNINGS AND PRECAUTIONS].

Effects During Pregnancy

Starting at 30 weeks gestation, Caldolor and other NSAIDs should be avoided by pregnant women as premature closure of the ductus arteriosus in the fetus may occur [see Use In Specific Populations].

Last reviewed on RxList: 1/29/2014
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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