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Mobic

Mobic (Meloxicam) side effects drug center

 

PROFESSIONAL

CONSUMER

SIDE EFFECTS

 

Mobic Side Effects Center

What Is Mobic?

Mobic (meloxicam) is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain or inflammation caused by arthritis. Mobic is available in generic form.

What Are Side Effects of Mobic?

Common side effects of Mobic include:

  • stomach upset,
  • nausea,
  • drowsiness,
  • diarrhea,
  • bloating,
  • gas,
  • dizziness,
  • nervousness,
  • headache,
  • runny or stuffy nose,
  • sore throat, or
  • skin rash.

Tell your doctor if less common but serious side effects of Mobic occur including:

Dosage for Mobic

The recommended adult starting and maintenance dose of Mobic is 7.5 mg. The maximum recommended adult daily oral dose is 15 mg.

What Drugs, Substances, or Supplements Interact with Mobic?

Mobic may interact with cyclosporine, lithium, diuretics (water pills), glyburide, methotrexate, blood thinners, steroids, ACE inhibitors, aspirin or other NSAIDs (nonsteroidal anti-inflammatory drugs). Tell your doctor all medications you use.

Mobic During Pregnancy and Breastfeeding

Mobic should be used only when prescribed during the first 6 months of pregnancy. It is not recommended for use during the last 3 months of pregnancy due to possible harm to a fetus. It is unknown if this medication passes into breast milk. Similar drugs pass into breast milk and are unlikely to harm a nursing infant. Consult your doctor before breastfeeding.

Additional Information

Our Mobic (meloxicam) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Mobic Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, feeling short of breath.

Stop using meloxicam and call your doctor at once if you have:

  • the first sign of any skin rash, no matter how mild;
  • shortness of breath (even with mild exertion);
  • swelling or rapid weight gain;
  • signs of 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 (anemia)--pale skin, unusual tiredness, feeling light-headed, cold hands and feet; or
  • kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath.

Common side effects may include:

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

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Mobic (Meloxicam)

 

Mobic Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

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

  Placebo MOBIC 7.5 mg daily MOBIC 15 mg daily Diclofenac 100 mg daily
No. of Patients 157 154 156 153
Gastrointestinal 17.2 20.1 17.3 28.1
  Abdominal pain 2.5 1.9 2.6 1.3
  Diarrhea 3.8 7.8 3.2 9.2
  Dyspepsia 4.5 4.5 4.5 6.5
  Flatulence 4.5 3.2 3.2 3.9
  Nausea 3.2 3.9 3.8 7.2
Body as a Whole
  Accident household 1.9 4.5 3.2 2.6
  Edema1 2.5 1.9 4.5 3.3
  Fall 0.6 2.6 0.0 1.3
  Influenza-like symptoms 5.1 4.5 5.8 2.6
Central and Peripheral Nervous System
  Dizziness 3.2 2.6 3.8 2.0
  Headache 10.2 7.8 8.3 5.9
Respiratory
  Pharyngitis 1.3 0.6 3.2 1.3
  Upper respiratory tract infection 1.9 3.2 1.9 3.3
Skin
  Rash2 2.5 2.6 0.6 2.0
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

  Placebo MOBIC
7.5 mg daily		 MOBIC
15 mg daily
No. of Patients 469 481 477
Gastrointestinal Disorders 14.1 18.9 16.8
  Abdominal pain NOS2 0.6 2.9 2.3
  Dyspeptic signs and symptoms1 3.8 5.8 4.0
  Nausea2 2.6 3.3 3.8
General Disorders and Administration Site Conditions
  Influenza-like illness2 2.1 2.9 2.3
Infection and Infestations
  Upper respiratory tract infections-pathogen class unspecified1 4.1 7.0 6.5
Musculoskeletal and Connective Tissue Disorders
  Joint related signs and symptoms1 1.9 1.5 2.3
Nervous System Disorders
  Headaches NOS2 6.4 6.4 5.5
Skin and Subcutaneous Tissue Disorders
 Rash NOS2 1.7 1.0 2.1
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 Trials 6 Month Controlled Trials
MOBIC 7.5 mg daily MOBIC 15 mg daily MOBIC 7.5 mg daily MOBIC 15 mg daily
No. of Patients 8955 256 169 306
Gastrointestinal 11.8 18.0 26.6 24.2
  Abdominal pain 2.7 2.3 4.7 2.9
  Constipation 0.8 1.2 1.8 2.6
  Diarrhea 1.9 2.7 5.9 2.6
  Dyspepsia 3.8 7.4 8.9 9.5
  Flatulence 0.5 0.4 3.0 2.6
  Nausea 2.4 4.7 4.7 7.2
  Vomiting 0.6 0.8 1.8 2.6
Body as a Whole
  Accident household 0.0 0.0 0.6 2.9
  Edema1 0.6 2.0 2.4 1.6
  Pain 0.9 2.0 3.6 5.2
Central and Peripheral Nervous System
  Dizziness 1.1 1.6 2.4 2.6
  Headache 2.4 2.7 3.6 2.6
Hematologic
Anemia 0.1 0.0 4.1 2.9
Musculoskeletal
Arthralgia 0.5 0.0 5.3 1.3
Back pain 0.5 0.4 3.0 0.7
Psychiatric
  Insomnia 0.4 0.0 3.6 1.6
Respiratory
  Coughing 0.2 0.8 2.4 1.0
  Upper respiratory tract infection 0.2 0.0 8.3 7.5
Skin
  Pruritiis 0.4 1.2 2.4 0.0
  Rash2 0.3 1.2 3.0 1.3
Urinary
  Mictiirition frequency 0.1 0.4 2.4 1.3
  Urinary tract infection 0.3 0.4 4.7 6.9
  Headache 2.4 2.7 3.6 2.6
Hematologic
  Anemia 0.1 0.0 4.1 2.9
Musculoskeletal
  Arthralgia 0.5 0.0 5.3 1.3
  Back pain 0.5 0.4 3.0 0.7
Psychiatric
  Insomnia 0.4 0.0 3.6 1.6
Respiratory
Coughing 0.2 0.8 2.4 1.0
Upper respiratory tract infection 0.2 0.0 8.3 7.5
Skin
   Pruritiis 0.4 1.2 2.4 0.0
  Rash2 0.3 1.2 3.0 1.3
Urinary
  Mictiirition frequency 0.1 0.4 2.4 1.3
  Urinary tract infection 0.3 0.4 4.7 6.9
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 Whole allergic reaction, face edema, fatigue, fever, hot flushes, malaise, syncope, weight decrease, weight increase
Cardiovascular angina pectoris, cardiac failure, hypertension, hypotension, myocardial infarction, vasculitis
Central and Peripheral Nervous System convulsions, paresthesia, tremor, vertigo
Gastrointestinal colitis, 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 Rhythm arrhythmia, palpitation, tachycardia
Hematologic leukopenia, purpura, thrombocytopenia
Liver and Biliary System ALT increased, AST increased, bilirubinemia, GGT increased, hepatitis
Metabolic and Nutritional dehydration
Psychiatric abnormal dreaming, anxiety, appetite increased, confusion, depression, nervousness, somnolence
Respiratory asthma, bronchospasm, dyspnea
Skin and Appendages alopecia, angioedema, bullous eruption, photosensitivity reaction, pruritus, sweating increased, urticaria
Special Senses abnormal vision, conjunctivitis, taste perversion, tinnitus
Urinary System albuminuria, 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: 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.

Read the entire FDA prescribing information for Mobic (Meloxicam)

&Copy; Mobic Patient Information is supplied by Cerner Multum, Inc. and Mobic Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.