Meloxicam (Page 3 of 9)
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 Tablets USP Phase 2/3 clinical trial database includes 10,122 OA patients and 1,012 RA patients treated with Meloxicam Tablets USP 7.5 mg/day, 3,505 OA patients and 1,351 RA patients treated with Meloxicam Tablets USP 15 mg/day. Meloxicam Tablets USP 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 2,363 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 Tablets USP 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 Tablets USP 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 Tablets USP with placebo.
Table 1a depicts adverse events that occurred in ≥ 2% of the Meloxicam Tablets USP treatment groups in a 12-week placebo- and active-controlled osteoarthritis trial.
Table 1b depicts adverse events that occurred in ≥ 2% of the Meloxicam Tablets USP treatment groups in two 12-week placebo-controlled rheumatoid arthritis trials.
Placebo | Meloxicam Tablets USP 7.5 mg daily | Meloxicam Tablets USP 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 * | 2.5 | 1.9 | 4.5 | 3.3 |
Fall | 0.6 | 2.6 | 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 |
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 † | 2.5 | 2.6 | 0.6 | 2 |
| |||
Placebo | Meloxicam Tablets USP 7.5 mg daily | Meloxicam Tablets USP 15 mg daily | |
No. of Patients | 469 | 481 | 477 |
Gastrointestinal Disorders | 14.1 | 18.9 | 16.8 |
Abdominal Pain NOS * | 0.6 | 2.9 | 2.3 |
Dyspeptic Signs and Symptoms † | 3.8 | 5.8 | 4 |
Nausea * | 2.6 | 3.3 | 3.8 |
General Disorders and Administration Site Conditions | |||
Influenza-Like Illness † | 2.1 | 2.9 | 2.3 |
Infection and Infestations | |||
Upper Respiratory Tract Infections- Pathogen Class Unspecified † | 4.1 | 7 | 6.5 |
Musculoskeletal and Connective Tissue Disorders | |||
Joint Related Signs and Symptoms † | 1.9 | 1.5 | 2.3 |
Nervous System Disorders | |||
Headaches NOS * | 6.4 | 6.4 | 5.5 |
Skin and Subcutaneous Tissue Disorders | |||
Rash NOS * | 1.7 | 1 | 2.1 |
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 Tablets USP 7.5 mg daily | Meloxicam Tablets USP 15 mg daily | Meloxicam Tablets USP 7.5 mg daily | Meloxicam Tablets USP 15 mg daily | |
No. of Patients | 8,955 | 256 | 169 | 306 |
Gastrointestinal | 11.8 | 18 | 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 | 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 | 0.6 | 2.9 |
Edema * | 0.6 | 2 | 2.4 | 1.6 |
Pain | 0.9 | 2 | 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 | 4.1 | 2.9 |
Musculoskeletal | ||||
Arthralgia | 0.5 | 0 | 5.3 | 1.3 |
Back Pain | 0.5 | 0.4 | 3 | 0.7 |
Psychiatric | ||||
Insomnia | 0.4 | 0 | 3.6 | 1.6 |
Respiratory | ||||
Coughing | 0.2 | 0.8 | 2.4 | 1 |
Upper Respiratory | 0.2 | 0 | 8.3 | 7.5 |
Tract Infection | ||||
Skin | ||||
Pruritus | 0.4 | 1.2 | 2.4 | 0 |
Rash † | 0.3 | 1.2 | 3 | 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 Meloxicam Tablets USP (22.5 mg and greater) have been associated with an increased risk of serious GI events; therefore, the daily dose of Meloxicam Tablets USP should not exceed 15 mg.
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