Mobic Side Effects

Generic name: meloxicam

Note: This document contains side effect information about meloxicam. Some of the dosage forms listed on this page may not apply to the brand name Mobic.

Some side effects of Mobic may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to meloxicam: oral suspension, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking meloxicam (the active ingredient contained in Mobic) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using meloxicam and call your doctor at once if you have a serious side effect such as:

• chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;

• black, bloody, or tarry stools;

• coughing up blood or vomit that looks like coffee grounds;

• swelling or rapid weight gain;

• urinating less than usual or not at all;

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• skin rash, bruising, severe tingling, numbness, pain, muscle weakness; or

• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects of meloxicam may include:

• upset stomach, diarrhea, bloating, gas;

• dizziness, nervousness, headache;

• runny or stuffy nose, sore throat; or

• mild skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to meloxicam: oral suspension, oral tablet

Gastrointestinal

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

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

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

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

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

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

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

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 (the active ingredient contained in Mobic) in less than 2% of patients. Acute urinary retention has been reported in less than 0.1% of patients in postmarketing experience.

Hypersensitivity

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

Hepatic

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

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

Renal

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 (the active ingredient contained in Mobic) (less than 2% of treated patients).

Other

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

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