Meloxicam (Page 3 of 8)

6 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 ( 5.1)]
  • Gastrointestinal effects – risk of GI ulceration, bleeding, and perforation [ see Boxed Warning and Warnings and Precautions ( 5.2) ]
  • Hepatic effects [see Warnings and Precautions ( 5.3)]
  • Hypertension [see Warnings and Precautions ( 5.4)]
  • Congestive heart failure and edema [see Warnings and Precautions ( 5.5)]
  • Renal effects [see Warnings and Precautions ( 5.6)]
  • Anaphylactoid reactions [ see Warnings and Precautions ( 5.7)]
  • Adverse skin reactions [see Warnings and Precautions ( 5.8)]

6.1 Clinical Trials Experience

Adults

Osteoarthritis and Rheumatoid Arthritis

The meloxicam Phase 2/3 clinical trial database includes 10,122 OA patients and 1012 RA patients treated with meloxicam 7.5 mg/day, 3505 OA patients and 1351 RA patients treated with meloxicam 15 mg/day. Meloxicam 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 meloxicam 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 meloxicam 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 meloxicam with placebo.

Table 1a depicts adverse events that occurred in ≥2% of the meloxicam treatment groups in a 12-week placebo- and active-controlled osteoarthritis trial.

Table 1b depicts adverse events that occurred in ≥2% of the meloxicam treatment groups in two 12-week placebo- controlled rheumatoid arthritis trials.

Table 1a Adverse Events (%) Occurring in ≥2% of Meloxicam Patients in a 12-Week Osteoarthritis Placebo- and Active-Controlled Trial
Placebo Meloxicam 7.5 mg daily Meloxicam 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
Edema 1 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
Rash 2 2.5 2.6 0.6 2.0

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

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

Meloxicam

7.5 mg daily

Meloxicam

15 mg

No. of Patients 469 481 477
Gastrointestinal Disorders 14.1 18.9 16.8
Abdominal Pain NOS 2 0.6 2.9 2.3
Dyspeptic signs and symptoms 1 3.8 5.8 4.0
Nausea 2 2.6 3.3 3.8
General Disorders and Administration Site Conditions
Influenza like illness 2 2.1 2.9 2.3
Infection and Infestations
Upper respiratory tract infections-pathogen class unspecified 1 4.1 7.0 6.5
Musculoskeletal and Connective Tissue Disorders
Joint related signs and symptoms 1 1.9 1.5 2.3
Nervous System Disorders
Headaches NOS 2 6.4 6.4 5.5
Skin and Subcutaneous Tissue Disorders
Rash NOS 2 1.7 1.0 2.1

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

The adverse events that occurred with meloxicam 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 Meloxicam Patients in 4 to 6 Weeks and 6 Month Active-Controlled Osteoarthritis Trials
4 to 6 Weeks Controlled Trials 6 month Controlled Trials

Meloxicam

7.5 mg daily

Meloxicam

15 mg daily

Meloxicam

7.5 mg daily

Meloxicam

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
Edema 1 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
Rash 2 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

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

Higher doses of meloxicam (22.5 mg and greater) have been associated with an increased risk of serious GI events; therefore the daily dose of meloxicam should not exceed 15 mg.

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