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Mobic (Meloxicam) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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, 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.

Table 2a Adverse Events (%) Occurring in ≥ 2% of MOBIC Patients in a 12-Week Osteoarthritis Placebo and Active-Controlled Trial
PlaceboMOBIC
7.5 mg daily
MOBIC
15 mg daily
Diclofenac
100 mg daily
No. of Patients157154156153
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
Gastrointestinal17.220.117.3 28.1
   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
   Headache10.2 7.88.35.9
Respiratory
   Pharyngitis1.30.63.21.3
   Upper Respiratory Tract
   Infection
1.93.21.93.3
Skin
   Rash22.52.60.62.0
Table 2b 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
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 disorders14.118.916.8
   Abdominal pain NOS20.62.92.3
   Diarrhea NOS25.14.83.4
   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
   Musculoskeletal and connective tissue
    signs and symptoms NEC1
3.81.72.9
Nervous system disorders
   Headaches NOS26.46.45.5
   Dizziness (excl vertigo)23.02.30.4
Skin and subcutaneous tissue disorders
   Rash NOS21.71.02.1

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.

Table 3 Adverse Events (%) Occurring in ≥ 2% of MOBIC Patients in 4 to 6 Weeks and 6 Month Active-Controlled Osteoarthritis Trials
4-6 Weeks Controlled Trials6 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 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
   Dizziness 1.11.62.42.6
   Headache2.42.73.62.6
Hematologic
   Anemia 0.10.04.12.9
Musculoskeletal
   Arthralgia 0.50.05.31.3
   Back Pain0.50.43.00.7
Psychiatric
   Insomnia 0.40.03.61.6
Respiratory
   Coughing0.20.82.41.0
   Upper Respiratory
   Tract Infection
0.20.08.37.5
Skin
   Pruritus0.41.22.40.0
   Rash20.31.23.01.3
Urinary
   Micturition Frequency0.10.42.41.3
   Urinary Tract Infection0.30.44.76.9

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 Wholeallergic reaction, anaphylactoid reactions including shock, 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
Hematologic agranulocytosis, leukopenia, purpura, thrombocytopenia
Liver and Biliary SystemALT increased, AST increased, bilirubinemia, GGT increased, hepatitis, jaundice, liver failure
Metabolic and Nutritionaldehydration
Psychiatricabnormal dreaming, alterations in mood (such as mood elevation), anxiety, appetite increased, confusion, depression, nervousness, somnolence
Respiratoryasthma, bronchospasm, dyspnea
Skin and Appendagesalopecia, angioedema, bullous eruption, erythema multiforme, photosensitivity reaction, pruritus, exfoliative dermatitis, Stevens-Johnson syndrome, sweating increased, toxic epidermal necrolysis, urticaria
Special Sensesabnormal vision, conjunctivitis, taste perversion, tinnitus
Urinary System acute urinary retention, albuminuria, BUN increased, creatinine increased, hematuria, interstitial nephritis, renal failure



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: 2008-04-17

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