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Side Effects > Meloxicam

Meloxicam Side Effects

Brand Names: Mobic

Please note - some side effects for Meloxicam may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).


For the consumer

For the professional

Side Effects of Meloxicam - for the consumer


Meloxicam

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Meloxicam:

Constipation; diarrhea; dizziness; gas; headache; heartburn; nausea; stomach upset; trouble sleeping.

Seek medical attention right away if any of these SEVERE side effects occur when using Meloxicam:

Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.


Meloxicam Suspension

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Meloxicam Suspension:

Constipation; diarrhea; dizziness; gas; headache; heartburn; nausea; stomach upset; trouble sleeping.

Seek medical attention right away if any of these SEVERE side effects occur when using Meloxicam Suspension:

Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.

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For the professional


Meloxicam

Adults

Osteoarthritis

The Meloxicam Phase 2/3 clinical trial database includes 10,122 OA patients treated with Meloxicam 7.5 mg/day and 3,505 OA 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. 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.

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

Table 2 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
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
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

The adverse events that occurred with Meloxicam in ≥ 2% 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
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
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
   Edema1 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
   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

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 occuring 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 and are considered rare (< 0.1%).

Body as a whole allergic reaction, anaphylactoid reactions including shock, face edema, fatigue, fever, hot flashes, 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 Disorders abnormal dreaming, 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

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More resources:

Drugs.com Mobic

PDR Meloxicam

MedFacts Meloxicam

Micromedex Meloxicam - Includes detailed dosage instructions.

FDA Mobic

Facts & Comparisons Meloxicam

FDA Meloxicam

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