Summary

More frequently reported side effects include: heartburn, nausea, and prolonged bleeding time. Continue reading for a comprehensive list of adverse effects.

Applies to piroxicam: oral capsule.

Serious side effects of Piroxicam

Along with its needed effects, piroxicam may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking piroxicam:

More common

• Bloating
• bloody or black, tarry stools
• burning upper stomach pain
• cloudy urine
• constipation
• decrease in urine output or decrease in urine-concentrating ability
• headache
• heartburn
• indigestion
• itching skin or rash
• loss of appetite
• nausea or vomiting
• pale skin
• severe stomach pain, cramping, or burning
• severe and continuing nausea
• swelling
• swelling of the face, fingers, feet, or lower legs
• trouble breathing
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting of blood or material that looks like coffee grounds
• weight changes

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 or tightness
• 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
• 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
• 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 or inflammation of the mouth
• swollen glands
• tenderness in the stomach area
• unpleasant breath odor
• unusually warm skin
• weakness or heaviness of the legs
• yellow eyes or skin

Rare

• Anxiety
• back or leg pains
• burning, dry, or itching eyes
• cold sweats
• coma
• cracks in the skin
• diarrhea
• discharge or 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

Get emergency help immediately if any of the following symptoms of overdose occur while taking piroxicam:

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

Other side effects of Piroxicam

Some side effects of piroxicam may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions 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
• trembling or shaking of the hands or feet

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.

General

The most commonly reported adverse effects are abdominal pain/discomfort, flatulence, nausea, epigastric distress, constipation, diarrhea, dizziness, and headache.^[Ref]

Gastrointestinal

Evidence from observational studies have shown administration of doses greater than 20 mg orally per day increases the risk for gastrointestinal (GI) side effects. This drug may be associated with a high risk of GI toxicity relative to other nonsteroidal anti-inflammatory drugs (NSAIDs). About 1 in 5 patients who develop serious upper GI adverse events due to NSAID therapy are symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occur in approximately 1% of patients whom are treated for 3 to 6 months and in 2% to 4% of patients treated for 1 year.^[Ref]

Common (1% to 10%): Anorexia, indigestion, abdominal pain/discomfort, constipation, diarrhea, dyspepsia, flatulence, gross bleeding/perforation, heartburn, nausea, gastric and duodenal ulcers, vomiting, epigastric distress

Uncommon (0.1% to 1%): Dry mouth, esophagitis, gastritis, glossitis, hematemesis, melena, rectal bleeding, stomatitis

Rare (0.01% to 0.1%): Colic, eructation, pancreatitis

Frequency not reported: Peptic ulceration, gastrointestinal hemorrhage^[Ref]

Renal

Common (1% to 10%): Abnormal renal function

Uncommon (0.1% to 1%): Renal papillary necrosis, glomerulonephritis, interstitial nephritis, nephrotic syndrome, renal failure^[Ref]

Renal toxicity while using piroxicam has occurred in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of NSAIDs may cause a dose dependent reduction in prostaglandin formation and secondarily, renal blood flow, which may precipitate overt renal decompensation.^[Ref]

Hepatic

Common (1% to 10%): Elevated liver enzymes

Uncommon (0.1% to 1%): Hepatitis, jaundice

Rare (0.01% to 0.1%): Liver failure^[Ref]

Significant elevations of the liver enzymes AST and ALT (about 3 or more times the upper limit of normal) have occurred in approximately 1% of patients in clinical trials with nonsteroidal anti-inflammatory drugs (NSAIDs). Borderline elevations have occurred in up to 15% of patients taking NSAIDs, including this drug.^[Ref]

Cardiovascular

Clinical trials of several COX-2 selective and nonselective nonsteroidal anti-inflammatory drugs (NSAIDs) of up to 3 years duration have shown an increased risk of serious and sometimes fatal cardiovascular thrombotic events, myocardial infarction, and stroke.^[Ref]

Common (1% to 10%): Edema

Uncommon (0.1% to 1%): Congestive heart failure, hypertension, tachycardia, syncope

Rare (0.01% to 0.1%): Arrhythmia, exacerbation of angina, hypotension, myocardial infarction, palpitations, vasculitis, chest pain

Frequency not reported: Arterial thrombotic events^[Ref]

Dermatologic

Common (1% to 10%): Pruritus, rash

Uncommon (0.1% to 1%): Alopecia, bruising, desquamation, erythema, photosensitivity,

Rare (0.01% to 0.1%): Toxic epidermal necrosis, erythema multiforme, exfoliative dermatitis, onycholysis, Stevens - Johnson syndrome, urticaria, vesiculobullous reaction, ecchymosis, petechial rash

Frequency not reported: Non-thrombocytopenic purpura (Henoch-Schonlein)^[Ref]

Observational studies suggest that piroxicam may be associated with a higher risk of severe cutaneous adverse reactions than other non-oxicam NSAIDs. There is an increased risk early in the course of therapy, with the majority of cases occurring within the first month.^[Ref]

Hematologic

Common (1% to 10%): Anemia, prolonged bleeding time

Uncommon (0.1% to 1%): Eosinophilia, leukopenia, purpura, thrombocytopenia

Rare (0.01% to 0.1%): Agranulocytosis, hemolytic anemia, aplastic anemia, lymphadenopathy, pancytopenia

Frequency not reported: Decreased hemoglobin and hematocrit^[Ref]

Hypersensitivity

Rare (0.01% to 0.1%): Anaphylaxis, angioedema

Frequency not reported: Serum sickness^[Ref]

A combination of dermatological/allergic signs and symptoms suggestive of serum sickness have occasionally occurred while using this drug. These include arthralgias, pruritus, fever, fatigue and rash (e.g., vesiculobullous reactions and exfoliative dermatitis).^[Ref]

Metabolic

Common (1% to 10%): Elevated BUN, elevated serum creatinine, anorexia

Uncommon (0.1% to 1%): Weight changes, hyperkalemia, fluid retention

Rare (0.01% to 0.1%): Appetite changes, hyperglycemia, hypoglycemia^[Ref]

Nervous system

Common (1% to 10%): Dizziness, headache, sedation

Uncommon (0.1% to 1%): Asthenia, drowsiness, malaise, paresthesia, somnolence, tremors, vertigo, amnesia

Rare (0.01% to 0.1%): Akathisia, convulsions, coma, meningitis

Postmarketing experience: Aseptic meningitis^[Ref]

Respiratory

Uncommon (0.1% to 1%): Asthma, dyspnea, epistaxis

Rare (0.01% to 0.1%): Respiratory depression, pneumonia

Frequency not reported: Bronchospasm^[Ref]

Other

Common (1% to 10%): Tinnitus, deafness

Uncommon (0.1% to 1%): Fever

Rare (0.01% to 0.1%): Death, hearing impairment, thirst^[Ref]

Endocrine

Rare (0.01% to 0.1%): Female fertility decreased^[Ref]

Immunologic

Uncommon (0.1% to 1%): Infections, sepsis

Rare (0.01% to 0.1%): Positive ANA, flu-like syndrome^[Ref]

Genitourinary

Uncommon (0.1% to 1%): Cystitis, dysuria, hematuria, oliguria, polyuria, proteinuria, urinary frequency, menorrhagia^[Ref]

Local

Rare (0.01% to 0.1%): Sweating^[Ref]

Ocular

Uncommon (0.1% to 1%): Blurred vision

Rare (0.01% to 0.1%): Conjunctivitis, swollen eyes^[Ref]

Psychiatric

Uncommon (0.1% to 1%): Anxiety, confusion, depression, dream abnormalities, personality changes

Rare (0.01% to 0.1%): Hallucinations, mood alterations, nervousness

Frequency not reported: Insomnia^[Ref]