Sign Out
Cardiovascular effects: Celecoxib may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction (MI) and stroke, which can be fatal. All NSAIDs may have a similar risk. This risk may increase with dose and duration of use. Patients with cardiovascular disease or cardiovascular risk factors may be at greater risk. To minimize the potential risk for an adverse cardiovascular event in patients treated with Celecoxib, 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 cardiovascular symptoms. Patients should be informed about the signs and symptoms of serious cardiovascular toxicity and the steps to take if they occur.
Celecoxib is not a substitute for aspirin for prophylaxis of cardiovascular thromboembolic disease because the lack of effect on platelet function. Because Celecoxib does not inhibit platelet aggregation, antiplatelet therapies (e.g., aspirin) should not be discontinued.
Renal effects: Celecoxib may cause renal toxicity like those of the non-selective NSAIDs. Patients at greatest risk for renal toxicity are those with impaired renal function, heart failure, liver dysfunction, and the elderly. Such patients should be carefully monitored while receiving treatment with Celecoxib.
Cautions should be used when initiating treatment in patients with dehydration. It is advisable to rehydrate patients first and then start therapy with Celecoxib.
Avoid use Celecoxib in patients with advanced renal disease.
Hepatic effects: The use of Celecoxib in patients with severe hepatic impairment (Child-Pugh class C) is not recommended. Celecoxib should be used with caution when treating patients with moderate hepatic impairment (Child-Pugh class B), and initiated at half the recommended dose.
Rare cases of severe hepatic reactions, including jaundice, fulminant hepatitis (some fatal), liver necrosis, and hepatic failure (some fatal or requiring liver transplant), have been reported in patients receiving Celecoxib.
A patient with symptoms and/or sign of liver dysfunction, or in whom an abnormal liver function test has occurred, should be monitored carefully for evidence of the development of a more severe hepatic reaction while on therapy with Celecoxib.
Gastrointestinal effects: NSAIDs cause an increased risk of serious gastrointestinal inflammation, ulceration, bleeding, and perforation (may be fatal). Upper and lower GI perforations, ulcers or bleeds have occurred in patients treated with Celecoxib. Patients most at risk of developing these types of GI complications with NSAIDs are the elderly, patients with cardiovascular disease, patients using concomitant glucocorticoids, antiplatelet drugs (such as aspirin), or other NSAIDs, patients using alcohol or patients with a prior history of, or active, GI disease such as ulceration, GI bleeding or inflammatory conditions. Most spontaneous reports of fatal GI events have been elderly or debilitated patients.
Hypertension: As with all NSAIDs, Celecoxib can lead to the onset of new hypertension or worsening of pre-existing hypertension. Celecoxib should be used with caution in patients with hypertension. Blood pressure should be monitored closely during the initiation of therapy with Celecoxib and throughout the course of therapy.
Fluid retention and edema: As with other drugs known to inhibit prostaglandin synthesis, fluid retention and edema have been observed in some patients taking Celecoxib. Therefore patients with pre-existing congestive heart failure or hypertension should be closely monitored. Celecoxib should be used with caution in patients with compromised cardiac function, pre-existing edema, or other conditions predisposing to, or worsened by, fluid retention including those taking diuretic treatment or otherwise at risk of hypovolemia.
Anaphylactoid reactions: As with NSAIDs in general, anaphylactoid reactions have occurred in patients exposed to Celecoxib.
Serious skin reactions: Serious skin reactions, some of them fatal, including drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrosis, have been occurred very rarely in association with the use of Celecoxib. Patients appear to be the highest risk for these events early in the course of therapy, the onset of the event occurring in the majority of cases within first month of treatment. Celecoxib should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Use with other NSAIDs: The concomitant use of Celecoxib and a non-aspirin NSAIDs should be avoided.
Use with oral anticoagulants: The concomitant use of NSAIDs with oral anticoagulants, including warfarin/coumarin-type and novel oral anticoagulants (e.g., apixaban, dabigatran and rivaroxaban), increases risk of bleeding and should be given with cautions. Serious bleeding events, some of them fatal, have been reported. Because increases in prothrombin time (INR) have been reported, anticoagulation/INR should be monitored after initiating treatment with Celecoxib or changing the dose.
General: By reducing inflammation, Celecoxib may diminish the utility of diagnostic signs, such as fever, in detecting infections.
CYP2D6 inhibition: Celecoxib has shown to be a moderately potent CYP2D6 inhibitor. For drugs that are metabolized by CYP2D6, a dose reduction during initiation of Celecoxib treatment or a dose increase upon termination of Celecoxib treatment may be necessary.
Effects on ability to drive and use machines: Celecoxib may have minor influence on the ability to drive and use machines. Patients who experience dizziness, vertigo or somnolence while taking Celecoxib should refrain from driving or operating machinery.
