From the Guidelines
Celebrex can cause significant side effects, including cardiovascular events, gastrointestinal bleeding, and renal complications, and its use should be carefully considered, especially in patients with a history of heart disease, hypertension, or kidney problems. The medication's mechanism of inhibiting COX-2 enzymes to reduce inflammation and pain can affect blood clotting and blood vessel function, explaining its cardiovascular risks 1. Common side effects of Celebrex include:
- Stomach pain
- Indigestion
- Heartburn
- Diarrhea
- Nausea
- Headache
- 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 bleeding (black stools, vomiting blood)
- Liver problems (yellowing of skin/eyes, dark urine)
- Kidney issues (decreased urination)
- Unexplained weight gain or swelling According to a study published in the American Family Physician, the use of COX-2 inhibitors, including Celebrex, is associated with an increased risk of myocardial infarction, and it is estimated that a person's mean blood pressure will increase by an average of 5 mm Hg while taking nonselective NSAIDs 1. The risk of gastrointestinal bleeding with Celebrex can be mitigated by combining it with a proton pump inhibitor (PPI) or misoprostol, but the risk of cardiovascular events should be carefully weighed against the potential benefits of the medication. Patients with a history of heart disease, high blood pressure, kidney problems, liver disease, or a history of stomach ulcers should discuss these concerns with their healthcare provider before starting treatment with Celebrex 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 [see Clinical Studies (14. 7)]. A randomized controlled trial entitled the Prospective Randomized Evaluation of Celecoxib Integrated Safety vs. Ibuprofen Or Naproxen (PRECISION) was conducted to assess the relative cardiovascular thrombotic risk of a COX-2 inhibitor, celecoxib, compared to the non-selective NSAIDs naproxen and ibuprofen 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 2
- Gastrointestinal events: serious GI adverse events, including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine 2, 2
- Hepatotoxicity: elevations of ALT or AST, sometimes fatal cases of severe hepatic injury, including fulminant hepatitis, liver necrosis, and hepatic failure 2, 2
- Hypertension: new onset or worsening of preexisting hypertension 2, 2
- Heart failure: approximately twofold increase in hospitalizations for heart failure 2, 2
- Renal toxicity: long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury 2, 2
From the Research
Celebrex Side Effects
- The gastrointestinal safety of celecoxib, a type of non-steroidal anti-inflammatory drug (NSAID), has been studied in patients with cardiothrombotic diseases and arthritis after upper gastrointestinal bleeding 3.
- The study found that celecoxib plus 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 reviewed the gastrointestinal and cardiovascular adverse events associated with NSAIDs, including celecoxib, and found that COX-2 selective agents like celecoxib are safer to the GI tract but have a worse CV profile 4.
- The study also found that naproxen seems safer for the CV system, but it is one of the NSAIDs with higher GI toxicity, and that co-therapy with aspirin reduces the GI benefits of COX-2 selective agents 4.
- A third study compared the safety of combining NSAIDs with low-dose aspirin and found that celecoxib has a more favorable overall safety profile than naproxen or ibuprofen when taken without aspirin 5.
- The study also found that adding aspirin attenuates the safety advantage of celecoxib, although celecoxib is still associated with fewer gastrointestinal events than ibuprofen or naproxen and fewer renal events than ibuprofen 5.
Common Side Effects
- Gastrointestinal events, such as upper gastrointestinal bleeding, gastric ulcers, and duodenal ulcers 3, 4, 5
- Cardiovascular events, such as major adverse cardiovascular events, noncardiovascular death, and renal events 4, 5
- Renal events, such as renal failure and renal impairment 5