Meloxicam

Meloxicam Tablets are a nonsteroidal anti-inflammatory drug (NSAID) indicated for relief of the signs and symptoms of osteoarthritis and rheumatoid arthritis. Meloxicam is available in generic form. Common side effects of meloxicam include:

• abdominal pain,
• diarrhea,
• indigestion,
• gas,
• nausea,
• swelling,
• falls,
• flu-like symptoms,
• dizziness,
• headache,
• sore throat,
• upper respiratory tract infection,
• skin rash,
• constipation,
• vomiting,
• joint pain,
• back pain,
• insomnia,
• coughing,
• itching,
• urinary frequency, and
• urinary tract infection.

For the relief of the signs and symptoms of osteoarthritis the recommended starting and maintenance oral dose of meloxicam is 7.5 mg once daily. For the relief of the signs and symptoms of rheumatoid arthritis, the recommended starting and maintenance oral dose of meloxicam is 7.5 mg once daily. Meloxicam may interact with ACE inhibitors, aspirin, cholestyramine, furosemide and thiazides, lithium, methotrexate, and warfarin. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using meloxicam. Meloxicam should not be used in the later stages of pregnancy as it can harm a fetus. It is unknown if meloxicam passes into breast milk. Because of the potential for adverse effects on a nursing infant, breastfeeding while using meloxicam is not recommended.

Our Meloxicam Tablets Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Meloxicam Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, feeling short of breath.

Stop using meloxicam and call your doctor at once if you have:

• the first sign of any skin rash, no matter how mild;
• shortness of breath (even with mild exertion);
• swelling or rapid weight gain;
• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• liver problems--nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed, cold hands and feet; or
• kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath.

Common side effects may include:

• stomach pain, nausea, vomiting, heartburn;
• diarrhea, constipation, gas;
• dizziness; or
• cold symptoms, flu symptoms.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Meloxicam (meloxicam )

 

Meloxicam Professional Information

SIDE EFFECTS

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, 3,505 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 2a depicts adverse events that occurred in ≥ 2% of the meloxicam treatment groups in a 12-week placebo and active-controlled osteoarthritis trial.

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

Table 2a : 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
Edema1	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
Rash2	2.5	2.6	0.6	2.0
1WHO preferred terms edema, edema dependent, edema peripheral and edema legs combined 2WHO preferred terms rash, rash erythematous and rash maculo-papular combined

Table 2b : 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 daily
No. of Patients	469	481	477
Gastrointestinal disorders	14.1	18.9	16.8
Abdominal pain NOS2	0.6	2.9	2.3
Diarrhea NOS2	5.1	4.8	3.4
Dyspeptic signs and symptoms1	3.8	5.8	4.0
Nausea2	2.6	3.3	3.8
General disorders and administration site conditions
Influenza like illness2	2.1	2.9	2.3
Infection and infestations
Upper respiratory tract infections-pathogen class unspecified1	4.1	7.0	6.5
Musculos keletal and connective tissue disorders
Joint related signs and symptoms1	1.9	1.5	2.3
Musculoskeletal and connective tissue signs and symptoms NEC1	3.8	1.7	2.9
Nervous system disorders
Headaches NOS2	6.4	6.4	5.5
Dizziness (excl vertigo)2	3.0	2.3	0.4
Skin and subcutaneous tissue disorders
Rash NOS2	1.7	1.0	2.1
1MedDRA 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) 2MedDRA preferred term: diarrhea NOS, nausea, abdominal pain NOS, influenza like illness, headaches NOS, dizziness (excl vertigo), and rash NOS The adverse events that occurred with meloxicam in ≥ 2% Generic Equivalent 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 Meloxicam Patients in 4 to 6 Weeks and 6 Month Active-Controlled Osteoarthritis Trials

	4-6 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
Gas trointes tinal	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
Edema1	0.6	2.0	2.4	1.6
Pain	0.9	2.0	3.6	5.2
Central and Peripheral Nervous Sys tem
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
Rash2	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
1WHO preferred terms edema, edema dependent, edema peripheral and edema legs combined 2WHO 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.

The following is a list of adverse drug reactions occurring in < 2% of patients receiving meloxicam 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 Whole allergic reaction, anaphylactoid reactions including shock, face edema, fatigue, fever, hot flushes, malaise, syncope, weight decrease, weight increase

Cardiovascular angina pectoris, cardiac failure, hypertension, hypotension, myocardial infarction, vasculitis

Central and Peripheral Nervous System convulsions, paresthesia, tremor, vertigo

Gastrointestinal colitis, 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 Rhythm arrhythmia, palpitation, tachycardia

Hematologic agranulocytosis, leukopenia, purpura, thrombocytopenia

Liver and Biliary System ALT increased, AST increased, bilirubinemia, GGT increased, hepatitis, jaundice, liver failure

Metabolic and Nutritional dehydration

Psychiatric abnormal dreaming, alterations in mood (such as mood elevation), anxiety, appetite increased, confusion, depression, nervousness, somnolence

Respiratory asthma, bronchospasm, dyspnea

Skin and Appendages alopecia, angioedema, bullous eruption, erythema multiforme, photosensitivity reaction, pruritus, exfoliative dermatitis, Stevens-Johnson syndrome, sweating increased, toxic epidermal necrolysis, urticaria

Special Senses abnormal vision, conjunctivitis, taste perversion, tinnitus

Urinary System acute urinary retention, albuminuria, BUN increased, creatinine increased, hematuria, interstitial nephritis, renal failure

Read the entire FDA prescribing information for Meloxicam (meloxicam )