Piroxicam Side Effects

It is possible that some side effects of piroxicam may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to piroxicam: oral capsule, oral tablet

As well as its needed effects, piroxicam may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking piroxicam, check with your doctor immediately:

More common
  • Bloating
  • bloody or black, tarry stools
  • burning upper abdominal or stomach pain
  • cloudy urine
  • constipation
  • decrease in urine output or decrease in urine-concentrating ability
  • headache
  • heartburn
  • indigestion
  • itching skin
  • loss of appetite
  • nausea or vomiting
  • pale skin
  • severe abdominal or stomach pain, cramping, or burning
  • severe and continuing nausea
  • skin rash
  • swelling
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting of blood or material that looks like coffee grounds
  • weight loss
Less common
  • Bleeding gums
  • blood in the urine
  • bloody nose
  • blurred vision
  • burning feeling in the chest or stomach
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chest pain
  • clay-colored stools
  • confusion
  • cough or hoarseness
  • dark urine
  • difficult or labored breathing
  • difficult, burning, or painful urination
  • difficulty with swallowing
  • dilated neck veins
  • dizziness
  • extreme fatigue
  • fainting
  • fever or chills
  • flushing or redness of the skin
  • frequent urge to urinate
  • increased sensitivity of the skin to sunlight
  • increased thirst
  • increased volume of pale, dilute urine
  • large, flat, blue, or purplish patches in the skin
  • lightheadedness
  • lower back or side pain
  • nervousness
  • noisy breathing
  • numbness or tingling in the hands, feet, or lips
  • pain or burning in the throat
  • peeling of the skin
  • pinpoint red or purple spots on the skin
  • pounding in the ears
  • rapid, shallow breathing
  • redness or other discoloration of the skin
  • redness, swelling, or soreness of the tongue
  • severe sunburn
  • shortness of breath
  • slow, fast, pounding, or irregular heartbeat or pulse
  • sore throat
  • sores, ulcers, or white spots on the lips or tongue or inside the mouth
  • stomach upset
  • swelling of the face, fingers, feet, or lower legs
  • swelling or inflammation of the mouth
  • swollen glands
  • tenderness in the stomach area
  • tightness in the chest
  • unpleasant breath odor
  • unusually warm skin
  • weakness or heaviness of the legs
  • weight gain
  • wheezing
  • yellow eyes or skin
Rare
  • Anxiety
  • back or leg pains
  • burning, dry, or itching eyes
  • cold sweats
  • coma
  • cracks in the skin
  • diarrhea
  • discharge, excessive tearing
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position
  • dry mouth
  • flushed, dry skin
  • fruit-like breath odor
  • general body swelling
  • general feeling of discomfort or illness
  • high fever
  • increased hunger
  • increased urination
  • inflammation of the joints
  • irregular, fast or slow, or shallow breathing
  • joint pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • light-colored stools
  • loss of heat from the body
  • muscle aches and pains
  • nightmares
  • no blood pressure
  • no breathing
  • no pulse
  • pain or discomfort in the arms, jaw, back, or neck
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pale or blue lips, fingernails, or skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  • runny nose
  • scaly skin
  • seeing, hearing, or feeling things that are not there
  • seizures
  • severe headache
  • shakiness
  • shivering
  • sleepiness
  • slurred speech
  • sneezing
  • sores, welting, or blisters
  • stiff neck or back
  • stomach pain, continuing
  • suddenly sweating
  • swollen, painful, or tender lymph glands in the neck, armpit, or groin
  • trouble sleeping

If any of the following symptoms of overdose occur while taking piroxicam, get emergency help immediately:

Symptoms of overdose
  • Agitation
  • depression
  • hives
  • hostility
  • irritability
  • muscle twitching
  • pain or discomfort in the chest, upper stomach, or throat
  • rapid weight gain
  • stupor
  • swelling of the ankles or hands
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Some piroxicam side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Acid or sour stomach
  • belching
  • continuing ringing or buzzing or other unexplained noise in the ears
  • excess air or gas in the stomach or intestines
  • hearing loss
  • passing gas
  • stomach discomfort or upset
Less common
  • Feeling of constant movement of self or surroundings
  • hair loss or thinning of the hair
  • lack or loss of strength
  • sensation of spinning
  • shakiness in the legs, arms, hands, or feet
  • sleeplessness
  • trembling or shaking of the hands or feet
  • unable to sleep
Rare
  • Change in hearing
  • changes in appetite
  • inability to sit still
  • mood alterations
  • need to keep moving
  • restlessness

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

Renal

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

Hematologic

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

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

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.[Ref]

Metabolic

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

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.[Ref]

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

Nervous system

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

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.[Ref]

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.[Ref]

Respiratory

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

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.[Ref]

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.[Ref]

References

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40. Sanada M, Takai K "Aplastic anaemia associated with piroxicam." Br J Haematol 77 (1991): 256-7

41. Lee SH, Fawcett V, Preece JM "Aplastic anaemia associated with piroxicam." Lancet 1 (1982): 1186

42. Bjornstad H, Vik O "Thrombocytopenic purpura associated with piroxicam." Br J Clin Pract 40 (1986): 42

43. Carmona MJ, Blanca M, Garcia A, Fernandez S, Burgos F, Miranda A, Vega JM, Garcia J "Intolerance to piroxicam in patients with adverse reactions to nonsteroidal antiinflammatory drugs." J Allergy Clin Immunol 90 (1992): 873-9

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