Meloxicamside effects

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 Most common adverse reactions (incidence ≥2% in controlled clinical trials of meloxicam capsules 5 mg or 10 mg group) are diarrhea, nausea, abdominal discomfort. To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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. Adverse Reactions in Patients with Osteoarthritis Pain Eight hundred sixty-eight patients with osteoarthritis pain, ranging in age from 40 to 87 years, were enrolled in two Phase 3 clinical trials and received meloxicam capsules 5 mg or 10 mg once daily. Fifty percent (50%) of patients were aged 61 years or older. Two hundred sixty-nine patients received meloxicam capsules 5 mg or 10 mg once daily in the 12-week, double-blind, placebo-controlled, clinical trial of osteoarthritis pain of the knee or hip. The most frequent adverse reactions in this study are summarized in Table 1. Table 1 Summary of Adverse Reactions (2%) – 12-Week Phase 3 Study in Patients With Osteoarthritis Pain Adverse Reactions Meloxicam Capsules 5 mg or 10 mg N=269 Placebo N=133 Diarrhea 3% 1% Nausea 2% 0 Abdominal Discomfort 2% 0 Six hundred patients received meloxicam capsules 10 mg once daily in a 52-week, open-label, clinical trial in osteoarthritis pain of the knee or hip. Of these, 390 (65%) patients completed the trial. The most frequent adverse reactions in this study are summarized in Table 2. Table 2 Summary of Adverse Reactions (2%) – 52-Week Open-Label Study in Patients With Osteoarthritis Pain Adverse Reactions Meloxicam Capsules 10 mg N=600 Arthralgia 6% Urinary Tract Infection 6% Osteoarthritis 5% Hypertension 4% Diarrhea 4% Headache 4% Upper Respiratory Tract Infection 4% Back Pain 4% Nasopharyngitis 4% Bronchitis 3% Sinusitis 3% Constipation 3% Dyspepsia 3% Nausea 2% Edema Peripheral 2% Pain in Extremity 2% Additional adverse reactions reported for meloxicam: Body as a Whole allergic reaction, face edema, fatigue, fever, hot flushes, malaise, syncope, weight decrease, weight increase Cardiovascular angina pectoris, cardiac failure, hypertension, hypotension, myocardial infarction, vasculitis Central and Peripheral Nervous System convulsions, paresthesia, tremor, vertigo Gastrointestinal colitis, dry mouth, duodenal ulcer, eructation, esophagitis, gastric ulcer, gastritis, gastroesophageal reflux, gastrointestinal hemorrhage, hematemesis, hemorrhagic duodenal ulcer, hemorrhagic gastric ulcer, intestinal perforation, melena, pancreatitis, perforated duodenal ulcer, perforated gastric ulcer, stomatitis ulcerative Heart Rate and Rhythm arrhythmia, palpitation, tachycardia Hematologic agranulocytosis, leukopenia, purpura, thrombocytopenia Immune System anaphylactoid reactions (including shock) Liver and Biliary System ALT increased, AST increased, bilirubinemia, GGT increased, hepatitis, jaundice, liver failure Metabolic and Nutritional dehydration Psychiatric abnormal dreaming, alterations in mood (such as mood elevation), anxiety, appetite increased, confusion, depression, nervousness, somnolence, Respiratory asthma, bronchospasm, dyspnea Skin and Appendages alopecia, angioedema, bullous eruption, erythema multiforme, exfoliative dermatitis, photosensitivity reaction, pruritus, Stevens-Johnson Syndrome, toxic epidermal necrolysis, sweating increased, urticaria Special Senses abnormal vision, conjunctivitis, taste perversion, tinnitus Urinary System albuminuria, acute urinary retention, BUN increased, creatinine increased, hematuria, interstitial nephritis, renal failure,

6.2 Postmarketing

Experience The following adverse reactions have been identified during postapproval use of meloxicam. 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.

Skin and Appendages: Exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and fixed drug eruption (FDE).