Meloxicam Side Effects

Brand Names: Mobic

Please note - some side effects for Meloxicam may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Meloxicam - for the consumer

Meloxicam

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Meloxicam:

Constipation; diarrhea; dizziness; gas; headache; heartburn; nausea; stomach upset; trouble sleeping.

Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.

Meloxicam Suspension

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Meloxicam Suspension:

Constipation; diarrhea; dizziness; gas; headache; heartburn; nausea; stomach upset; trouble sleeping.

Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.

For the professional

Meloxicam

Adults

Osteoarthritis and Rheumatoid Arthritis

The Meloxicam Phase 2/3 clinical trial database includes 10,122 OA patients and 1012 RA patients treated with Meloxicam 7.5 mg/day and 3,505 OA patients and 1351 RA patients treated with Meloxicam 15 mg/day. Meloxicam at these doses was administered to 661 patients for at least 6 months and to 312 patients for at least one year. Approximately 10,500 of these patients were treated in ten placebo and/or active-controlled osteoarthritis trials and 2363 of this patients were treated in ten placebo and/or active controlled rheumatoid arthritis trials. Gastrointestinal (GI) adverse events were the most frequently reported adverse events in all treatment groups across Meloxicam trials.

A 12-week multicenter, double-blind, randomized trial was conducted in patients with osteoarthritis of the knee or hip to compare the efficacy and safety of Meloxicam with placebo and with an active control. Two 12-week multicenter, double-blind, randomized trials were conducted in patients with rheumatoid arthritis to compare the efficacy and safety of Meloxicam with placebo.

Table 2a depicts adverse events that occurred in ≥ 2% of the Meloxicam treatment groups in a 12-week placebo and active-controlled osteoarthritis trial.

Table 2b depicts adverse events that occurred in ≥2% of the Meloxicam treatment groups in two 12-week placebo controlled rheumatoid arthritis trials.

The adverse events that occurred with Meloxicam in ≥ 2% of patients treated short-term (4-6 weeks) and long-term (6 months) in active-controlled osteoarthritis trials are presented in Table 3.

Higher doses of Meloxicam (22.5 mg and greater) have been associated with an increased risk of serious GI events; therefore the daily dose of Meloxicam should not exceed 15 mg.

The following is a list of adverse drug reactions occurring in < 2% of patients receiving Meloxicam in clinical trials involving approximately 16,200 patients. Adverse reactions reported only in worldwide post-marketing experience or the literature are shown in italics.

By body system

Gastrointestinal side effects

Flatulence and dyspepsia were either as common or more frequent among placebo patients. Gastrointestinal side effects have been the most frequently reported adverse events from over 10 placebo-controlled trials with patients with osteoarthritis.

Gastrointestinal (GI) side effects have included abdominal pain in 2% to 5%, constipation in 1% to 3%, diarrhea in 2% to 6%, dyspepsia in 4% to 10%, flatulence in 1% to 3%, nausea in 2% to 7%, and vomiting in up to 3% of patients. Other GI side effects reported in less than 2% of patients have included colitis, dry mouth, duodenal ulcer, eructation, esophagitis, gastric ulcer, gastritis, gastroesophageal reflux, gastrointestinal hemorrhage, hematemesis, hemorrhagic perforation, melena, pancreatitis, perforated duodenal ulcer, perforated gastric ulcer, and ulcerative stomatitis.

Nervous system side effects

Nervous system side effects have included headache (2% to 8%), dizziness (1% to 3%), and insomnia (0% to 4%). Nervous system side effects reported in less than 2% of treated patients have included convulsions, paresthesia, tremor, vertigo, abnormal vision, conjunctivitis, taste perversion, and tinnitus.

Cardiovascular side effects

Cardiovascular side effects have included edema which has been reported by approximately 1% to 5% of patients involved in studies. Other cardiovascular side effects have included angina pectoris, cardiac failure, hypertension, hypotension, myocardial infarction, vasculitis, arrhythmia, dehydration or decreased intravascular volume, palpitations, and tachycardia.

Respiratory side effects

Respiratory system side effects have included cough in up to 2% and pharyngitis or upper respiratory infection in up to 8% of patients. The incidence of infection was similar in some studies among placebo patients or patients taking another NSAID. A causal relationship was not established. Respiratory system side effects in less than 2% of patients have included asthma, bronchospasm, and dyspnea.

Dermatologic side effects

Dermatologic side effects have included rash (1% to 3%) and pruritus in up to 2% of patients. Dermatologic side effects observed in less than 2% of patients have included alopecia, angioedema, bullous eruption, erythema multiforme, photosensitivity reaction, pruritus, Stevens-Johnson syndrome, increased sweating, toxic epidermal necrolysis, and urticaria.

Hematologic side effects

Hematologic side effects have included anemia (reported in more than 2% of patients, but only in some studies.) The incidence has ranged from 0.1% to 4%. Stool sampling for blood loss was not reported in these studies. Other hematologic side effects have included agranulocytosis, leukopenia, purpura, and thrombocytopenia.

Musculoskeletal side effects

Musculoskeletal side effects have included arthralgias in up to 5% and back pain in up to 3% of patients. (The underlying condition of test patients was osteoarthritis.)

Genitourinary side effects

Genitourinary side effects have included new urinary tract infections in up to 7% of patients (it has been the only genitourinary complaint reported in at least 2% of patients.) Hematuria has been associated with the use of meloxicam in less than 2% of patients. Acute urinary retention has been reported in less than 0.1% of patients in postmarketing experience.

Hypersensitivity side effects

Hypersensitivity reactions have included anaphylactic shock, facial edema, fever, hot flashes, syncope, fatigue, and malaise.

Hepatic side effects

Hepatic side effects have been rarely reported (2% or less). These have included, increased serum enzymes (ALT, AST, and GGT), bilirubinemia, hepatitis, jaundice, and liver failure.

Psychiatric side effects

Psychiatric side effects have included abnormal dreaming, anxiety, confusion, depression, nervousness, and somnolence.

Renal side effects

Renal side effects have included urinary frequency, albuminuria, increased BUN, increased serum creatinine, hematuria, interstitial nephritis, and renal failure. New or worsened renal insufficiency has been rarely associated with the use of meloxicam (less than 2% of treated patients).

Other side effects

Other side effects including household accident have been reported in greater than or equal to 2% of patients.

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