Side Effects of Mobic (meloxicam)

Mobic (meloxicam) is a nonsteroidal anti-inflammatory drug (NSAID) used to treat tenderness, swelling, and pain caused by the inflammation of osteoarthritis, rheumatoid arthritis, and juvenile rheumatoid arthritis in patients 2 years of age or older. 

Prostaglandins are chemicals that contribute to inflammation especially within joints, and it is the inflammation that leads to the common symptoms of pain, tenderness, and swelling associated with arthritis. 

Mobic blocks the enzymes that make prostaglandins (cyclooxygenase 1 and 2) and reduces the levels of prostaglandins. As a result, inflammation and its accompanying symptoms are reduced. 

Common side effects of Mobic include

• stomach pain,
• nausea,
• vomiting,
• heartburn,
• diarrhea,
• constipation,
• gas,
• dizziness, and
• cold or flu symptoms.

Serious side effects of Mobic include

• skin rash,
• shortness of breath (even with mild exertion),
• swelling or rapid weight gain,
• stomach bleeding (bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds),
• liver problems (nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes),
• low red blood cells (pale skin, unusual tiredness, lightheadedness, cold hands and feet), and
• kidney problems (little or no urination, swelling in your feet or ankles, feeling tired or short of breath).

Drug interactions of Mobic include lithium, because Mobic may increase the blood levels of lithium by reducing the excretion of lithium by the kidneys, which may lead to lithium toxicity. 

• Mobic may reduce the blood pressure-lowering effects of drugs given to reduce blood pressure. 
• When Mobic is used in combination with methotrexate or aminoglycosides the blood levels of the Mobic or aminoglycoside may increase, presumably because their elimination from the body is reduced. 
• This may lead to more Mobic or aminoglycoside-related side effects. Mobic increases the negative effect of cyclosporine on kidney function and reduces the effect of furosemide and thiazide diuretics because of prostaglandin inhibition. Individuals taking oral blood thinners, for example, warfarin, should avoid Mobic because Mobic also thins the blood, and excessive blood thinning may lead to bleeding. 
• Mobic should be avoided by patients with a history of asthma attacks, hives, or other allergic reactions to aspirin or other NSAIDs. 
• If aspirin is taken with Mobic there may be an increased risk for developing a gastrointestinal ulcer. 
• Persons who have more than three alcoholic beverages per day may be at increased risk of developing stomach ulcers when taking Mobic or other NSAIDs. 
• Cholestyramine, colestipol, and colesevelam may decrease the effectiveness of Mobic by preventing its absorption from the intestine. There have been no studies of Mobic in preg

Because Mobic may cause a fetal birth defect called ductus arteriosus (early closure of two major blood vessels of the heart and lung) it should be avoided during pregnancy. 

It is unknown if Mobic is excreted in breast milk. Consult your doctor before breastfeeding.

WARNING

• Individuals who are allergic to NSAIDs may experience shortness of breath when given an NSAID. People with asthma also are at a higher risk for experiencing serious allergic reaction to NSAIDs. Individuals with a serious allergy to one NSAID are likely to experience a similar reaction to a different NSAID.
• New onset or worsening of high blood pressure (hypertension) may occur. Blood pressure should be monitored closely during treatment.
• Meloxicam may cause fluid retention and swelling (edema). It should be used cautiously in people with heart failure.
• Meloxicam may reduce kidney function. Therefore, it should not be used in people with severe kidney failure. It should be used cautiously in the elderly, people with heart failure, liver dysfunction, and those taking diuretics, ACE-inhibitors, or angiotensin II antagonists.
• Serious skin reactions such as exfoliative dermatitis, Stevens- Johnson syndrome, and toxic epidermal necrolysis (TEN) may occur without warning.
• NSAIDs (except low dose aspirin) may increase the risk of potentially fatal heart attacks, stroke, and related conditions in people with or without heart disease or risk factors for heart disease. The increased risk of heart attack or stroke may occur as early as the first week of use and the risk may increase with longer use and is higher in patients who have underlying risk factors for heart and blood vessel disease. Therefore, NSAIDs should not be used for the treatment of pain resulting from coronary artery bypass graft (CABG) surgery.
• Central nervous system effects including drowsiness, dizziness, and blurred vision may occur in patients who are taking an NSAIDs.

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

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.

Adults

Osteoarthritis And Rheumatoid Arthritis

The Mobic Phase 2/3 clinical trial database includes 10,122 OA patients and 1012 RA patients treated with Mobic 7.5 mg/day, 3505 OA patients and 1351 RA patients treated with Mobic 15 mg/day. Mobic 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 activecontrolled osteoarthritis trials and 2363 of these patients were treated in ten placebo- and/or activecontrolled rheumatoid arthritis trials. Gastrointestinal (GI) adverse events were the most frequently reported adverse events in all treatment groups across Mobic 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 Mobic 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 Mobic with placebo.

Table 1a depicts adverse events that occurred in ≥ 2% of the Mobic treatment groups in a 12-week placebo- and active-controlled osteoarthritis trial.

Table 1b depicts adverse events that occurred in ≥ 2% of the Mobic treatment groups in two 12-week placebo-controlled rheumatoid arthritis trials.

Table 1a : Adverse Events (%) Occurring in ≥ 2% of Mobic Patients in a 12-Week Osteoarthritis Placebo- and Active-Controlled Trial

Table 1b : Adverse Events (%) Occurring in ≥ 2% of Mobic Patients in two 12-Week Rheumatoid Arthritis Placebo-Controlled Trials

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

Table 2 : Adverse Events (%) Occurring in ≥ 2% of Mobic Patients in 4 to 6 Weeks and 6 Month Active-Controlled Osteoarthritis Trials

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

Pediatrics

Pauciarticular And Polyarticular Course Juvenile Rheumatoid Arthritis (JRA)

Three hundred and eighty-seven patients with pauciarticular and polyarticular course JRA were exposed to Mobic with doses ranging from 0.125 to 0.375 mg/kg per day in three clinical trials. These studies consisted of two 12-week multicenter, double-blind, randomized trials (one with a 12-week open-label extension and one with a 40-week extension) and one 1-year open-label PK study.

The adverse events observed in these pediatric studies with Mobic were similar in nature to the adult clinical trial experience, although there were differences in frequency.

In particular, the following most common adverse events, abdominal pain, vomiting, diarrhea, headache, and pyrexia, were more common in the pediatric than in the adult trials.

Rash was reported in seven ( < 2%) patients receiving Mobic. No unexpected adverse events were identified during the course of the trials. The adverse events did not demonstrate an age or gender-specific subgroup effect.

The following is a list of adverse drug reactions occurring in < 2% of patients receiving Mobic in clinical trials involving approximately 16,200 patients.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Mobic. 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.

Decisions about whether to include an adverse event from spontaneous reports in labeling are typically based on one or more of the following factors:

• (1) seriousness of the event,
• (2) number of reports, or
• (3) strength of causal relationship to the drug.

Adverse reactions reported in worldwide post marketing experience or the literature include:

• acute urinary retention;
• agranulocytosis;
• alterations in mood (such as mood elevation);
• anaphylactoid reactions including shock;
• erythema multiforme;
• exfoliative dermatitis;
• interstitial nephritis;
• jaundice;
• liver failure;
• Stevens-Johnson syndrome;
• toxic epidermal necrolysis, and
• infertility female.

See Table 3 for clinically significant drug interactions with meloxicam.

Table 3 : Clinically Significant Drug Interactions with Meloxicam