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).
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For the consumer For the professional
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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:
Seek medical attention right away if any of these SEVERE side effects occur when using Meloxicam:Constipation; diarrhea; dizziness; gas; headache; heartburn; nausea; stomach upset; trouble sleeping.
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:
Seek medical attention right away if any of these SEVERE side effects occur when using Meloxicam Suspension:Constipation; diarrhea; dizziness; gas; headache; heartburn; nausea; stomach upset; trouble sleeping.
TopSevere 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.
For the professional
Meloxicam
Adults
OsteoarthritisThe 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.
| 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.
| 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 |
More resources:
Meloxicam - Includes detailed dosage instructions.
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