Mobic Side Effects
Generic Name: Meloxicam
Please note - some side effects for Mobic may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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For the consumer For the professional
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Side Effects of Mobic - for the consumer
Mobic
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Mobic:
Seek medical attention right away if any of these SEVERE side effects occur when using Mobic:Constipation; diarrhea; dizziness; gas; headache; heartburn; nausea; stomach upset; trouble sleeping.
Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.
Mobic Suspension
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Mobic Suspension:
Seek medical attention right away if any of these SEVERE side effects occur when using Mobic Suspension:Constipation; diarrhea; dizziness; gas; headache; heartburn; nausea; stomach upset; trouble sleeping.
TopSevere allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.
For the professional
Mobic
Adults
Osteoarthritis and Rheumatoid ArthritisThe Mobic Phase 2/3 clinical trial database includes 10,122 OA patients and 1012 RA patients treated with Mobic 7.5 mg/day, 3,505 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 active-controlled osteoarthritis trials and 2363 of these patients were treated in ten placebo and/or active-controlled 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 2a depicts adverse events that occurred in ≥ 2% of the Mobic treatment groups in a 12-week placebo and active-controlled osteoarthritis trial.
Table 2b depicts adverse events that occurred in ≥ 2% of the Mobic treatment groups in two 12-week placebo controlled rheumatoid arthritis trials.
| Placebo | Mobic 7.5 mg daily |
Mobic 15 mg daily |
Diclofenac 100 mg daily |
|
|---|---|---|---|---|
| No. of Patients | 157 | 154 | 156 | 153 |
| 1 WHO preferred terms edema, edema dependent, edema peripheral and edema legs combined | ||||
| 2 WHO preferred terms rash, rash erythematous and rash maculo-papular combined | ||||
| 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 |
| Placebo | Mobic 7.5 mg daily |
Mobic 15 mg daily |
|
|---|---|---|---|
| No. of Patients | 469 | 481 | 477 |
| 1 MedDRA 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), and musculoskeletal and connective tissue signs and symptoms NEC (back pain, back pain aggravated, muscle spasms, musculoskeletal pain) | |||
| 2 MedDRA preferred term: diarrhea NOS, nausea, abdominal pain NOS, influenza like illness, headaches NOS, dizziness (excl vertigo), and rash NOS | |||
| Gastrointestinal disorders | 14.1 | 18.9 | 16.8 |
| Abdominal pain NOS2 | 0.6 | 2.9 | 2.3 |
| Diarrhea NOS2 | 5.1 | 4.8 | 3.4 |
| 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 |
| Musculoskeletal and connective tissue signs and symptoms NEC1 |
3.8 | 1.7 | 2.9 |
| Nervous system disorders | |||
| Headaches NOS2 | 6.4 | 6.4 | 5.5 |
| Dizziness (excl vertigo)2 | 3.0 | 2.3 | 0.4 |
| Skin and subcutaneous tissue disorders | |||
| Rash NOS2 | 1.7 | 1.0 | 2.1 |
The adverse events that occurred with Mobic in ≥ 2% of patients treated short-term (4-6 weeks) and long-term (6 months) in active-controlled osteoarthritis trials are presented in Table 3.
| 4-6 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 |
||
| 1 WHO preferred terms edema, edema dependent, edema peripheral and edema legs combined | |||||
| 2 WHO preferred terms rash, rash erythematous and rash maculo-papular combined | |||||
| 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 | |||||
| Pruritus | 0.4 | 1.2 | 2.4 | 0.0 | |
| Rash2 | 0.3 | 1.2 | 3.0 | 1.3 | |
| Urinary | |||||
| Micturition Frequency | 0.1 | 0.4 | 2.4 | 1.3 | |
| Urinary Tract Infection | 0.3 | 0.4 | 4.7 | 6.9 | |
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. Adverse reactions reported only in worldwide post-marketing experience or the literature are shown in italics.
| Body as a Whole | allergic reaction, anaphylactoid reactions including shock, 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 | agranulocytosis, leukopenia, purpura, thrombocytopenia |
| Liver and Biliary System | ALT increased, AST increased, bilirubinemia, GGT increased, hepatitis, jaundice, liver failure |
| Metabolic and Nutritional | dehydration |
| Psychiatric | abnormal dreaming, alterations in mood (such as mood elevation), anxiety, appetite increased, confusion, depression, nervousness, somnolence |
| Respiratory | asthma, bronchospasm, dyspnea |
| Skin and Appendages | alopecia, angioedema, bullous eruption, erythema multiforme, photosensitivity reaction, pruritus, exfoliative dermatitis, Stevens-Johnson syndrome, sweating increased, toxic epidermal necrolysis, urticaria |
| Special Senses | abnormal vision, conjunctivitis, taste perversion, tinnitus |
| Urinary System | acute urinary retention, albuminuria, BUN increased, creatinine increased, hematuria, interstitial nephritis, renal failure |
More resources:
Mobic - Includes detailed dosage instructions.
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