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Mobic (Meloxicam) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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.

The following serious adverse reactions are discussed elsewhere in the labeling:

  • Cardiovascular thrombotic events [ see Boxed Warning and Warnings and Precautions ]
  • Gastrointestinal effects – risk of GI ulceration, bleeding, and perforation [ see Boxed Warning and Warnings and Precautions ]
  • Hepatic effects [ see Warnings and Precautions ]
  • Hypertension [ see Warnings and Precautions ]
  • Congestive heart failure and edema [ see Warnings and Precautions ]
  • Renal effects [ see Warnings and Precautions ]
  • Anaphylactoid reactions [ see Warnings and Precautions ]
  • Adverse skin reactions [ see Warnings and Precautions ]

Clinical TrialsExperience

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 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 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
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
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
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)
2 MedDRA preferred term: nausea, abdominal pain NOS, influenza-like illness, headaches NOS, and rash NOS
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

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
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 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.

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

Post Marketing 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, and toxic epidermal necrolysis.



REPORTS OF SUSPECTED MOBIC SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Mobic. The information is not vetted and should not be considered as verified clinical evidence.

Possible Mobic side effects / adverse reactions in 70 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2011-10-03

Patient: 70 year old male

Reactions: Interstitial Lung Disease

Adverse event resulted in: hospitalization

Suspect drug(s):
Amlodipine Besylate
    Dosage: 5 mg, unk

Mobic
    Administration route: Oral

Other drugs received by patient: Pravastatin Sodium



Possible Mobic side effects / adverse reactions in 67 year old male

Reported by a health professional (non-physician/pharmacist) from Ireland on 2011-10-05

Patient: 67 year old male

Reactions: Renal Impairment

Adverse event resulted in: hospitalization

Suspect drug(s):
Mobicam
    Indication: Postoperative Care

Mobic
    Dosage: 15 mg
    Administration route: Oral
    Indication: Postoperative Care
    Start date: 2009-03-01

Other drugs received by patient: NU-Seals 75mg Gastro-Resistant Tablets; Diovan HCT; Zanidip 20mg Film Coated Tablets; Nexium; Ventolin; Seretide 250 Evohaler 25/250ug/dose Pressure



Possible Mobic side effects / adverse reactions in 84 year old female

Reported by a physician from Japan on 2011-10-05

Patient: 84 year old female

Reactions: Peptic Ulcer

Suspect drug(s):
Loxonin
    Dosage: 1 per 1 day
    Administration route: Oral
    Indication: Pain
    Start date: 2009-07-01
    End date: 2011-07-29

Mobic
    Dosage: 1 per 1 day
    Administration route: Oral
    Indication: Pain
    Start date: 2009-07-01
    End date: 2011-08-31

Tramadol Hydrochloride/acetaminophen
    Administration route: Oral
    Indication: Pain
    Start date: 2011-07-19
    End date: 2011-08-31



See index of all Mobic side effect reports >>

Drug label data at the top of this Page last updated: 2012-03-15

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