FELDENE® Adverse Reactions

(piroxicam)

6 ADVERSE REACTIONS

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

6.1 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% to 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

6.2 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

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Adverse Reactions

6 ADVERSE REACTIONS

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

6.1 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% to 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

6.2 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

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