Piroxicam Side Effects

Some side effects of piroxicam may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to piroxicam: oral capsule

Get emergency medical help if you have any of these signs of an allergic reaction while taking piroxicam: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking piroxicam and seek medical attention or call your doctor at once if you have any of these serious side effects:

• chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;

• black, bloody, or tarry stools;

• coughing up blood or vomit that looks like coffee grounds;

• swelling or rapid weight gain;

• urinating less than usual or not at all;

• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;

• bruising, severe tingling, numbness, pain, muscle weakness; or

• fever, headache, neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions).

Less serious side effects of piroxicam may include:

• upset stomach, mild heartburn or stomach pain, diarrhea, constipation;

• bloating, gas;

• dizziness, headache, nervousness;

• skin itching or rash;

• blurred vision; or

• ringing in your ears.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

For Healthcare Professionals

Applies to piroxicam: compounding powder, oral capsule

Gastrointestinal

Gastrointestinal side effects, occurring in up to 20% of patients, include epigastric distress, nausea, abdominal discomfort or pain, constipation, diarrhea, and mouth ulcerations. More serious gastrointestinal effects include peptic ulcers, hemorrhage, perforation, esophageal ulcerations, small bowel obstruction, and pancreatitis.

In one safety review, the overall incidence of serious gastrointestinal side effects was less than 0.2%. The manufacturer reports a higher incidence, 2% to 4%, of serious gastrointestinal events in patients treated with piroxicam for up to one year.

Patients with a history of serious gastrointestinal events or alcohol abuse are at increased risk for severe gastrointestinal side effects. Piroxicam should be used with caution in these patients.

Hepatic

Hepatic side effects include elevations in serum transaminases in up to 15% of patients. Rare cases of hepatitis, cholestatic jaundice, and fatal submassive hepatic necrosis have been reported as well. Cautious use of piroxicam and frequent monitoring of liver function tests during therapy is recommended in patients with liver disease.

Elevations in serum transaminases three times normal values are reported in less than 1% of patients.

Fatal cases of fulminant hepatitis are reported in the literature. Autopsies in these cases revealed submassive hepatic necrosis. In another case, the patient, a 48-year-old male, underwent a successful liver transplant. Piroxicam-induced hepatitis may be a result of a hypersensitivity in some cases, with an initial presentation of rash, urticaria, angioedema, and edema in the extremities.

Although rare in occurrence, sulindac-associated choledocholithiasis was reported in an 84-year-old woman after 3 years of sulindac treatment for rheumatoid arthritis.

Renal

Renal failure, interstitial nephritis, minimal-change nephrotic syndrome, papillary necrosis, elevations in serum creatinine, elevations in blood urea nitrogen, proteinuria, and hematuria have been associated with piroxicam therapy. In addition, nephropathy with Henoch-Schonlein purpura has been reported.

Piroxicam may impair the ability of the kidney to cope with low renal blood flow states due to inhibition of prostaglandin-dependent afferent arteriolar vasodilation. Renal function may be further compromised in patients with heart failure, hypovolemia, cirrhosis, nephrotic syndrome, or hypoalbuminemia. Additional risk factors for piroxicam-induced renal insufficiency are advanced age and concomitant use of diuretics.

A case-control study suggested that patients who consumed 5000 or more pills containing NSAIDs during their lifetime may be at increased risk of end-stage renal disease.

Dermatologic

Dermatologic side effects include pruritus, rash, erythema, photosensitivity, phototoxicity, fixed drug eruptions, Lyell's syndrome, and bruising. In addition, pemphigus vulgaris, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema annular centrifugum have been reported.

Photosensitivity or phototoxicity due to piroxicam is reported in the literature. Such reactions typically occur within the first few days of therapy and may present as pruritic, erythematous, vesicular eruptions on sun exposed areas. Some authors have suggested that a piroxicam metabolite or intermediate piroxicam photoproducts are the photosensitizers, not piroxicam itself. Further study is needed to clarify the mechanism, however.

Hematologic

Hematologic abnormalities include reductions in hematocrit and hemoglobin (3% to 9%), leukopenia, eosinophilia, and thrombocytopenia. Aplastic anemia has also been reported.

Aplastic anemia has been reported and, at least in one case, has resulted in patient death despite proper management.

Hypersensitivity

Hypersensitivity reactions occur in less than 1% of patients and include anaphylaxis, bronchospasm, angioedema, urticaria, vasculitis, and serum sickness. Signs and symptoms of a hypersensitivity were present in some cases of piroxicam-induced hepatitis and renal disease.

Metabolic

Metabolic side effects include hyperkalemia, hyperchloremia, and metabolic acidosis, as well as hypoglycemia and hyperglycemia.

Immunologic

Two cases of piroxicam-induced Henoch-Schonlein purpura, a vasculitis caused by circulating immune complexes containing IgA, have been reported in the literature. In both cases, symptoms resolved rapidly following the discontinuation of piroxicam. In one patient, rechallenge with a single dose of piroxicam resulted in recurrence of Henoch-Schonlein purpura and the associated nephropathy.

Immunologic side effects are rare but include Henoch-Schonlein purpura, exacerbation of systemic lupus erythematosus, and positive ANA titer.

Nervous system

Nervous system side effects include dizziness (3% to 9%), headache (3% to 9%), fatigue, vertigo, and paresthesias.

Cardiovascular

Cardiovascular side effects reported include edema, worsening of heart failure, and exacerbation of angina. In addition, blood pressure may be elevated by piroxicam which may have clinical relevance in patients with comorbid illnesses.

In one safety review, edema occurred more frequently in elderly patients (0.67%) compared to young patients (0.28%).

Nonsteroidal anti-inflammatory drugs (NSAIDs) may elevate blood pressure and increase the risk for the initiation of antihypertensive therapy. Furthermore, NSAIDs may antagonize the blood pressure lowering effect of antihypertensive medications in patients already being treated with antihypertensive drugs.

Respiratory

Respiratory side effects are rare, but pulmonary infiltrates and associated eosinophilia have been reported.

Other

Tinnitus and transient hearing loss have been associated with the use of piroxicam. A case of sudden, irreversible, sensorineural hearing loss has also been reported.

Sudden, irreversible, sensorineural hearing loss in a 63-year-old female has been reported. Onset of fullness followed by tinnitus and hearing loss in the right ear occurred within 30 minutes of the first 20 mg dose. The fullness and tinnitus resolved over several days. However, the hearing loss persisted.

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