What are the side effects of Celebrex (Celecoxib)?

From the Guidelines

Celebrex (celecoxib) can cause several serious side effects, including cardiovascular events, gastrointestinal bleeding, and liver or kidney problems, and patients should take it at the lowest effective dose for the shortest duration possible to minimize these risks. Common side effects of Celebrex include stomach pain, indigestion, heartburn, diarrhea, nausea, headache, and dizziness. More serious side effects that require immediate medical attention include cardiovascular events (heart attack, stroke), severe allergic reactions (rash, hives, difficulty breathing), stomach or intestinal problems (bleeding, ulcers), liver problems (yellowing of skin/eyes, dark urine), kidney issues (changes in urination), and unexplained weight gain or swelling.

Key Considerations

• The risk of gastrointestinal bleeding with Celebrex is dependent on age and patient history, with a one-year risk of one in 2,100 adults younger than 45 and one in 110 adults older than 75 1.
• Celebrex can increase the risk of cardiovascular events, including heart attack and stroke, particularly in patients with a history of cardiovascular disease or risk factors for cardiovascular disease 1.
• Patients with heart disease, high blood pressure, history of stomach ulcers, kidney or liver disease, or allergies to sulfa drugs or NSAIDs face higher risks and should discuss these conditions with their doctor before taking Celebrex 1.

Recommendations

• Patients should be carefully evaluated for their individual risk of cardiovascular and gastrointestinal events before starting Celebrex, and alternative treatments should be considered if possible.
• The lowest effective dose of Celebrex should be used for the shortest duration possible to minimize the risk of side effects.
• Patients taking Celebrex should be monitored regularly for signs of cardiovascular and gastrointestinal events, and should seek medical attention immediately if they experience any symptoms of these conditions.

Important Warnings

• Celebrex can increase the risk of serious cardiovascular events, including heart attack and stroke, and should be used with caution in patients with a history of cardiovascular disease or risk factors for cardiovascular disease 1.
• Celebrex can cause gastrointestinal bleeding, ulcers, and perforation, and should be used with caution in patients with a history of gastrointestinal disease or risk factors for gastrointestinal bleeding 1.

From the FDA Drug Label

The increases in both celecoxib dose groups versus placebo-treated patients were mainly due to an increased incidence of myocardial infarction NSAIDs, including celecoxib cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal Elevations of ALT or AST (three or more times the upper limit of normal [ULN]) have been reported in approximately 1% of NSAID-treated patients in clinical trials. NSAIDs, including celecoxib capsules can lead to new onset of hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. The Coxib and traditional NSAID Trialists’ Collaboration meta-analysis of randomized controlled trials demonstrated an approximately twofold increase in hospitalizations for heart failure in COX-2 selective-treated patients and nonselective NSAID-treated patients compared to placebo-treated patients Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury.

Celebrex side effects include:

• Cardiovascular events: increased risk of myocardial infarction, stroke, and cardiovascular death
• Gastrointestinal events: risk of GI bleeding, ulceration, and perforation
• Hepatotoxicity: elevations of ALT or AST, rare cases of severe hepatic injury
• Hypertension: new onset or worsening of preexisting hypertension
• Heart failure: increased risk of hospitalizations for heart failure
• Renal toxicity: long-term administration may result in renal papillary necrosis and other renal injury 2, 2, 2

From the Research

Celebrex Side Effects

• The side effects of Celebrex, a COX-2 selective inhibitor, have been studied in various clinical trials and research studies 3, 4, 5, 6, 7.
• One study found that Celebrex plus a proton-pump inhibitor is the preferred treatment to reduce the risk of recurrent upper gastrointestinal bleeding in patients at high risk of both cardiovascular and gastrointestinal events who require concomitant aspirin and NSAID 3.
• Another study found that the risk of cardiovascular disease and gastrointestinal bleeding is comparable between Celebrex and non-selective non-steroidal anti-inflammatory drugs in patients with ankylosing spondylitis 4.
• A meta-analysis found that Celebrex may be associated with an increased risk of myocardial infarction, but the increase in incidence rate of cardiovascular events is small in absolute terms 5.
• Celebrex seems safer for both the upper and the lower GI tract compared to other NSAIDs, but co-therapy with aspirin reduces the GI benefits of COX-2 selective agents 6.
• The data currently available suggests that both specific and non-specific COX inhibitors may increase the risk of serious cardiovascular events, but that the effect varies between the individual drugs, and Celebrex therapy may be associated with an increased risk of cardiovascular events, but only when used at doses substantially higher than those recommended for the treatment of arthritis 7.

Gastrointestinal Side Effects

• Celebrex has been found to be safer for the GI tract compared to non-selective NSAIDs, with a lower risk of recurrent upper gastrointestinal bleeding 3.
• However, co-therapy with aspirin reduces the GI benefits of COX-2 selective agents, and ibuprofen and naproxen may neglect the antiplatelet effect of aspirin 6.
• Celebrex seems safer for both the upper and the lower GI tract compared to other NSAIDs 6.

Cardiovascular Side Effects

• The risk of cardiovascular disease is comparable between Celebrex and non-selective non-steroidal anti-inflammatory drugs in patients with ankylosing spondylitis 4.
• A meta-analysis found that Celebrex may be associated with an increased risk of myocardial infarction, but the increase in incidence rate of cardiovascular events is small in absolute terms 5.
• Celebrex therapy may be associated with an increased risk of cardiovascular events, but only when used at doses substantially higher than those recommended for the treatment of arthritis 7.