Does Mobic (meloxicam) cause side effects?

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

Serious side effects of Mobic include

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.

What are the important side effects of Mobic (meloxicam)?

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.

Mobic (meloxicam) side effects list for healthcare professionals

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

PlaceboMobic 7.5 mg dailyMobic 15 mg dailyDiclofenac 100 mg daily
No. of Patients157154156153
Gastrointestinal17.220.117.328.1
  Abdominal pain2.51.92.61.3
  Diarrhea3.87.83.29.2
  Dyspepsia4.54.54.56.5
  Flatulence4.53.23.23.9
  Nausea3.23.93.87.2
Body as a Whole
  Accident household1.94.53.22.6
  Edema12.51.94.53.3
  Fall0.62.60.01.3
  Influenza-like symptoms5.14.55.82.6
Central and Peripheral Nervous System
  Dizziness3.22.63.82.0
  Headache10.27.88.35.9
Respiratory
  Pharyngitis1.30.63.21.3
  Upper respiratory tract infection1.93.21.93.3
Skin
  Rash22.52.60.62.0
1WHO preferred terms edema, edema dependent, edema peripheral, and edema legs combined
2WHO preferred terms rash, rash erythematous, and rash maculo-papular combined

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

PlaceboMobic
7.5 mg daily
Mobic
15 mg daily
No. of Patients469481477
Gastrointestinal Disorders14.118.916.8
  Abdominal pain NOS20.62.92.3
  Dyspeptic signs and symptoms13.85.84.0
  Nausea22.63.33.8
General Disorders and Administration Site Conditions
  Influenza-like illness22.12.92.3
Infection and Infestations
  Upper respiratory tract infections-pathogen class unspecified1 4.17.06.5
Musculoskeletal and Connective Tissue Disorders
  Joint related signs and symptoms11.91.52.3
Nervous System Disorders
  Headaches NOS26.46.45.5
Skin and Subcutaneous Tissue Disorders
 Rash NOS21.71.02.1
1MedDRA high level term (preferred terms): dyspeptic signs and symptoms (dyspepsia, dyspepsia aggravated, eructation, gastrointestinal irritation), upper respiratory tract infections-pathogen unspecified (laryngitis NOS, pharyngitis NOS, sinusitis NOS), joint related signs and symptoms (arthralgia, arthralgia aggravated, joint crepitation, joint effusion, joint swelling)
2MedDRA preferred term: nausea, abdominal pain NOS, influenza-like illness, headaches NOS, and rash NOS

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

4 to 6 Weeks Controlled Trials6 Month Controlled Trials
Mobic 7.5 mg dailyMobic 15 mg dailyMobic 7.5 mg dailyMobic 15 mg daily
No. of Patients8955256169306
Gastrointestinal11.818.026.624.2
  Abdominal pain2.72.34.72.9
  Constipation0.81.21.82.6
  Diarrhea1.92.75.92.6
  Dyspepsia3.87.48.99.5
  Flatulence0.50.43.02.6
  Nausea2.44.74.77.2
  Vomiting0.60.81.82.6
Body as a Whole
  Accident household0.00.00.62.9
  Edema10.62.02.41.6
  Pain0.92.03.65.2
Central and Peripheral Nervous System
  Dizziness1.11.62.42.6
  Headache2.42.73.62.6
Hematologic
Anemia0.10.04.12.9
Musculoskeletal
Arthralgia0.50.05.31.3
Back pain0.50.43.00.7
Psychiatric
  Insomnia0.40.03.61.6
Respiratory
  Coughing0.20.82.41.0
  Upper respiratory tract infection0.20.08.37.5
Skin
  Pruritiis0.41.22.40.0
  Rash20.31.23.01.3
Urinary
  Mictiirition frequency0.10.42.41.3
  Urinary tract infection0.30.44.76.9
  Headache2.42.73.62.6
Hematologic
  Anemia0.10.04.12.9
Musculoskeletal
  Arthralgia0.50.05.31.3
  Back pain0.50.43.00.7
Psychiatric
  Insomnia0.40.03.61.6
Respiratory
Coughing0.20.82.41.0
Upper respiratory tract infection0.20.08.37.5
Skin
   Pruritiis0.41.22.40.0
  Rash20.31.23.01.3
Urinary
  Mictiirition frequency0.10.42.41.3
  Urinary tract infection0.30.44.76.9
1WHO preferred terms edema, edema dependent, edema peripheral, and edema legs combined
2WHO preferred terms rash, rash erythematous, and rash maculo-papular combined

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.

Body as a Wholeallergic reaction, face edema, fatigue, fever, hot flushes, malaise, syncope, weight decrease, weight increase
Cardiovascularangina pectoris, cardiac failure, hypertension, hypotension, myocardial infarction, vasculitis
Central and Peripheral Nervous Systemconvulsions, paresthesia, tremor, vertigo
Gastrointestinalcolitis, 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 Rhythmarrhythmia, palpitation, tachycardia
Hematologicleukopenia, purpura, thrombocytopenia
Liver and Biliary SystemALT increased, AST increased, bilirubinemia, GGT increased, hepatitis
Metabolic and Nutritionaldehydration
Psychiatricabnormal dreaming, anxiety, appetite increased, confusion, depression, nervousness, somnolence
Respiratoryasthma, bronchospasm, dyspnea
Skin and Appendagesalopecia, angioedema, bullous eruption, photosensitivity reaction, pruritus, sweating increased, urticaria
Special Sensesabnormal vision, conjunctivitis, taste perversion, tinnitus
Urinary Systemalbuminuria, BUN increased, creatinine increased, hematuria, renal failure

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:

What drugs interact with Mobic (meloxicam)?

See Table 3 for clinically significant drug interactions with meloxicam.

Table 3 : Clinically Significant Drug Interactions with Meloxicam

Drugs that Interfere with Hemostasis
Clinical Impact:
  • Meloxicam and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of meloxicam and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone.
  • Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone.
Intervention: Monitor patients with concomitant use of Mobic with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding.
Aspirin
Clinical Impact: Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone.
Intervention: Concomitant use of Mobic and low dose aspirin or analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding. Mobic is not a substitute for low dose aspirin for cardiovascular protection
ACE Inhibitors, Angiotensin Receptor Blockers, or Beta-Blockers
Clinical Impact:
  • NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol).
  • In patients who are elderly, volume-depleted (including those on diuretic therapy), or have renal impairment, co-administration of an NSAID with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible.
Intervention:
  • During concomitant use of Mobic and ACE inhibitors, ARBs, or beta-blockers, monitor blood pressure to ensure that the desired blood pressure is obtained.
  • During concomitant use of Mobic and ACE inhibitors or ARBs in patients who are elderly, volume-depleted, or have impaired renal function, monitor for signs of worsening renal function.
  • When these drugs are administered concomitantly, patients should be adequately hydrated. Assess renal function at the beginning of the concomitant treatment and periodically thereafter.
Diuretics
Clinical Impact: Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis. However, studies with furosemide agents and meloxicam have not demonstrated a reduction in natriuretic effect. Furosemide single and multiple dose pharmacodynamics and pharmacokinetics are not affected by multiple doses of meloxicam
Intervention: During concomitant use of Mobic with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects.
Lithium
Clinical Impact: NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance decreased by approximately 20%. This effect has been attributed to NSAID inhibition of renal prostaglandin synthesis.
Intervention: During concomitant use of Mobic and lithium, monitor patients for signs of lithium to xicity.
Methotrexate
Clinical Impact: Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction).
Intervention: During concomitant use of Mobic and methotrexate, monitor patients for methotrexate to xicity.
Cyclosporine
Clinical Impact: Concomitant use of Mobic and cyclosporine may increase cyclosporine's nephrotoxicity.
Intervention: During concomitant use of Mobic and cyclosporine, monitor patients for signs of worsening renal function
NSAIDs and Salicylates
Clinical Impact: Concomitant use of meloxicam with other NSAIDs or salicylates (e.g., diflunisal, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy.
Intervention: The concomitant use of meloxicam with other NSAIDs or salicylates is not recommended.
Pemetrexed
Clinical Impact: Concomitant use of Mobic and pemetrexed may increase the risk of pemetrexed-associated myelosuppression renal, and GI toxicity (see the pemetrexed prescribing information).
Intervention: During concomitant use of Mobic and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI toxicity. Patients taking meloxicam should interrupt dosing for at least five days before, the day of, and two days following pemetrexed administration. In patients with creatinine clearance below 45 mL/min, the concomitant administration of meloxicam with pemetrexed is not recommended.

Summary

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. Common side effects of Mobic include stomach pain, nausea, vomiting, heartburn, diarrhea, constipation, gas, dizziness, and cold or flu symptoms. There have been no studies of Mobic in pregnant women. It is unknown if Mobic is excreted in breast milk.

Treatment & Diagnosis

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Medically Reviewed on 9/25/2020
References
FDA Prescribing Information

Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.
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