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.
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
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.
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.
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.