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.

Table 1a. Adverse Events (%) Occurring in ≥ 2% of Meloxicam Tablets USP Patients in a 12-Week Osteoarthritis Placebo- and Active-Controlled Trial
*
WHO preferred terms edema, edema dependent, edema peripheral and edema legs combined
WHO preferred terms rash, rash erythematous and rash maculo-papular combined

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

Table 1b. Adverse Events (%) Occurring in ≥ 2% of Meloxicam Tablets USP Patients in Two 12-Week Rheumatoid Arthritis Placebo-Controlled Trials
*
MedDRA preferred term: nausea, abdominal pain NOS, influenza like illness, headaches NOS and rash NOS
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)

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.

Table 2. Adverse Events (%) Occurring in ≥ 2% of Meloxicam Tablets USP Patients in 4 to 6 Weeks and 6 Month Active-Controlled Osteoarthritis Trials
*
WHO preferred terms edema, edema dependent, edema peripheral and edema legs combined
WHO preferred terms rash, rash erythematous and rash maculo-papular combined

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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