MOBIC is a non-steroidal anti-inflammatory drug indicated for:

• Osteoarthritis (OA)
• Rheumatoid Arthritis (RA)
• Juvenile Rheumatoid Arthritis (JRA) in patients 2 years of age or older

• Most common (≥5% and greater than placebo) adverse events in adults are diarrhea, upper respiratory tract infections, dyspepsia, and influenzalike symptoms
• Adverse events observed in pediatric studies were similar in nature to the adult clinical trial experience

• Concomitant use of MOBIC and warfarin may result in increased risk of bleeding complications
• Concomitant use of MOBIC and aspirin is not generally recommended because of the potential of increased adverse effect including increased GI bleeding
• Concomitant use with MOBIC increases lithium plasma levels
• Concomitant use with NSAIDs may reduce the antihypertensive effect of ACE-inhibitors
• Due to the presence of sorbitol in MOBIC oral suspension, there may be a risk of intestinal necrosis (possibly fatal) when the oral suspension is administered concomitantly with sodium polystyrene sulfonate

• Serious and potentially fatal cardiovascular (CV) thrombotic events, myocardial infarction, and stroke. Patients with known CV disease/risk factors may be at greater risk.
• Serious gastrointestinal (GI) adverse events which can be fatal. The risk is greater in patients with a prior history of ulcer disease or GI bleeding, and in patients at higher risk for GI events, especially the elderly.
• Elevated liver enzymes, and rarely, severe hepatic reactions. Discontinue use immediately if abnormal liver enzymes persist or worsen.
• New onset or worsening of hypertension. Blood pressure should be monitored closely during treatment.
• Fluid retention and edema. Should be used with caution in patients with fluid retention or heart failure.
• Renal papillary necrosis and other renal injury with long-term use. Use with caution in the elderly, those with impaired renal function, heart failure, liver dysfunction, and those taking diuretics, ACE-inhibitors, or angiotensin II antagonists. The use of MOBIC in patients with severe renal impairment is not recommended.
• Serious skin adverse events such as exfoliative dermatitis, StevensJohnson syndrome (SJS), and toxic  epidermal necrolysis (TEN), which can be fatal and can occur without warning. Discontinue MOBIC at first appearance of rash or skin reactions.