Side Effects of Feldene (piroxicam)

Feldene (piroxicam) is a nonsteroidal anti-inflammatory drug (NSAID) used to treat fever, pain, and inflammation in the body.

NSAIDs are non-narcotic relievers of mild to moderate pain of many causes, including injury, menstrual cramps, arthritis, and other musculoskeletal conditions. NSAIDs work by reducing levels of prostaglandins, chemicals responsible for pain, fever, and inflammation.

Feldene blocks the enzyme that makes prostaglandins (cyclooxygenase), resulting in lower concentrations of prostaglandins. As a result, inflammation, pain and fever are reduced. 

Common side effects of Feldene include

• rash,
• headaches,
• dizziness,
• drowsiness,
• abdominal pain,
• nausea,
• constipation,
• fluid retention,
• ringing in the ears, and
• sensitivity to sunlight.

Serious side effects of Feldene include

• increased bleeding after an injury,
• stomach and intestinal bleeding and ulcers (signs include black tarry stools, weakness, and dizziness upon standing),
• impaired kidney function,
• allergic reactions (more common in patients with asthma),
• fluid retention,
• blood clots,
• heart attacks,
• high blood pressure (hypertension), and
• heart failure.

Drug interactions of Feldene include lithium, because Feldene may reduce the excretion of lithium by the kidneys which can lead to lithium toxicity.

• Feldene may reduce the blood pressure lowering effects of blood pressure medications.
• Combining NSAIDs such as Feldene with angiotensin receptor blockers (ARBs) or angiotensin converting enzyme (ACE) inhibitors in patients who are elderly, volume-depleted (including those on diuretic therapy), or with poor kidney function may result in reduced kidney function, including kidney failure.
• When Feldene is used in combination with methotrexate or aminoglycoside antibiotics the blood levels of methotrexate or aminoglycoside may increase, which may lead to more methotrexate- or aminoglycoside- related side effects.
• Individuals taking oral blood thinners or anticoagulants, for example, warfarin, should avoid Feldene because Feldene also thins the blood, and excessive blood thinning may lead to bleeding.
• Alcohol consumption may increase the risk of developing stomach ulcers when taking Feldene or other NSAIDs.

Safety of Feldene during pregnancy has not been established. Use of Feldene in late pregnancy may cause premature closing of the ductus arteriosus in the fetus. Feldene is excreted into human breast milk. Use by breastfeeding mothers is not recommended.

The most common side effects of piroxicam are:

• rash,
• headaches,
• dizziness,
• drowsiness,
• abdominal pain,
• nausea,
• constipation,
• fluid retention,
• ringing in the ears, and
• photosensitivity.

NSAIDs reduce the ability of blood to clot and therefore increase bleeding after an injury.

Piroxicam also may cause stomach and intestinal bleeding and ulcers. Sometimes, stomach ulceration and intestinal bleeding can occur without any abdominal pain. Black tarry stools, weakness, and dizziness upon standing may be the only signs of the bleeding. People who are allergic to other NSAIDs should not use piroxicam.

NSAIDs reduce the flow of blood to the kidneys and impair function of the kidneys. The impairment is most likely to occur in patients with preexisting impairment of kidney function or congestive heart failure, and use of NSAIDs in these patients should be done cautiously.

Individuals with asthma are more likely to experience allergic reactions to prioxicam and other NSAIDs. Fluid retention, blood clots, heart attacks, hypertension, and heart failure have also been associated with the use of NSAIDs.

The following adverse reactions are discussed in greater detail in other sections of the labeling:

• Cardiovascular Thrombotic Events
• GI Bleeding, Ulceration and Perforation
• Hepatotoxicity
• Hypertension
• Heart Failure and Edema
• Renal Toxicity and Hyperkalemia
• Anaphylactic Reactions
• Serious Skin Reactions
• Hematologic Toxicity

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In patients taking Feldene or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1–10% of patients are:

Cardiovascular System: Edema

Digestive System: Anorexia, abdominal pain, constipation, diarrhea, flatulence, nausea, vomiting

Nervous System: Dizziness, headache, vertigo

Skin and Appendages: Pruritus, rash

Special Senses: Tinnitus

Additional adverse experiences reported occasionally include:

Cardiovascular System: Palpitations

Digestive System: Stomatitis

Nervous System: Drowsiness

Special Senses: Blurred vision

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Feldene. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Body As a Whole: Fever, infection, sepsis, anaphylactic reactions, appetite changes, death, flu-like syndrome, pain (colic), serum sickness

Cardiovascular System: Congestive heart failure, hypertension, tachycardia, syncope, arrhythmia, exacerbation of angina, hypotension, myocardial infarction, vasculitis

Digestive System: Dyspepsia, elevated liver enzymes, gross bleeding/perforation, heartburn, ulcers (gastric/duodenal), dry mouth, esophagitis, gastritis, glossitis, hematemesis, hepatitis, jaundice, melena, rectal bleeding, eructation, liver failure, pancreatitis

Hemic and Lymphatic System: Anemia, increased bleeding time, ecchymosis, eosinophilia, epistaxis, leukopenia, purpura, petechial rash, thrombocytopenia, agranulocytosis, hemolytic anemia, aplastic anemia, lymphadenopathy, pancytopenia

Hypersensitivity: Positive ANA

Metabolic and Nutritional: Weight changes, Fluid retention, hyperglycemia, hypoglycemia

Nervous System: Anxiety, asthenia, confusion, depression, dream abnormalities, insomnia, malaise, nervousness, paresthesia, somnolence, tremors, akathisia, convulsions, coma, hallucinations, meningitis, mood alterations

Respiratory System: Asthma, dyspnea, respiratory depression, pneumonia

Skin and Appendages: Alopecia, bruising, desquamation, erythema, photosensitivity, sweat, angioedema, toxic epidermal necrosis, erythema multiforme, exfoliative dermatitis, onycholysis, Stevens Johnson Syndrome, urticaria, vesiculobullous reaction

Special Senses: Conjunctivitis, hearing impairment, swollen eyes

Urogenital System: Abnormal renal function, cystitis, dysuria, hematuria, hyperkalemia, interstitial nephritis, nephrotic syndrome, oliguria/polyuria, proteinuria, renal failure, glomerulonephritis

Reproductive system and breast disorders: Female fertility decreased

See Table 1 for clinically significant drug interactions with piroxicam.

Table 1: Clinically Significant Drug Interactions with Piroxicam