Adverse Reactions
Gastrointestinal (Gl) adverse events were the most frequently reported adverse events in all treatment groups across Xobix (Meloxicam) trials.
The adverse events reported include abdominal pain, diarrhoea, flatulence, nausea, oedema, dizziness, headache, skin rash, insomnia, flu like syndrome, etc. As with other NSAIDs, higher doses of Xobix (e.g. chronic daily 30 mg dose) were associated with an increased risk of serious Gl events, therefore the daily dose of Xobix (Meloxicam) should not exceed 15 mg.
The following adverse events which may be causally related with the administration of Xobix (Meloxicam) have been reported. The frequencies given below are based on corresponding occurrences in clinical trials, regardless of any causal relationship. The information is based on clinical trials involving 3750 patients who have been treated with daily oral dose of 7.5mg or 15mg Xobix (Meloxicam).
Gastrointestinal Side Effects
Dyspepsia, nausea, vomiting, abdominal pain, constipation, flatulence, diarrhoea (more frequent than 1%). Transitory abnormalities of liver function parameters e.g. raised transaminases or bilirubin eructation, Oesophagitis, gastro duodenal ulcer, occult or macroscopic gastrointestinal bleeding (between 0.1% and 1%). Gastro intestinal perforation, colitis, hepatitis, gastritis (less frequent than 0.1%).
Hematological Side Effects
Anemia (more frequent than 1%), Disturbances of blood count, including differential white cell count, leukopenia and thrombocytopenia. Concomitant administration of a potentially myelotoxic drug, in particular methotrexate, appears to be a predisposing factor to the onset of a cytopenia (between 0.1% and 1%).
Dermatological Side Effects
Pruritus, skin rash (more frequent than 1%): stomatitis, urticaria (between 0.1% and 1%): photosensitisation, on rare Occasion’s bullous reactions, erythema multiforme. Stevens Johnson Syndrome. Toxic Epidermal Necrolysis may develop (less frequent than 0.1%).
Respiratory Side Effects
Onset of acute asthma has been reported (less frequent than 0.1%) in certain individuals following the administration of aspirin or other NSAIDs, including Xobix (Meloxicam).
Central Nervous System
Light-headedness, headache (more frequent than 1%): vertigo, tinnitus, drowsiness (between 0.1% and 1 %): confusion and disorientation (less frequent than 0.1%).
Cardiovascular Side Effects
Oedema (more frequent than 1 %): increase of Wood pressure, palpitations, flushes (between 0.1% and 1%).
Vision disorders
Conjunctivitis, visual disturbances including blurred vision (less frequent than 0.1%).
Hypersensitivity reactions
Angio-oedema and immediate hypersensitivity reactions including anaphylactoid / anaphylactic reactions (less frequent than 0.1%).
