During controlled clinical studies with the recommended dosage, the incidence of adverse effects associated with CLARINASE REPETABS Tablets was comparable to that of placebo, with the exception of insomnia and dry mouth, both of which were commonly reported.
Other reported adverse reactions associated with both CLARINASE REPETABS Tablets and placebo included headache and somnolence.
Rare adverse reactions in decreasing order of frequency included nervousness, dizziness, fatigue, nausea, abdominal distress, anorexia, thirst, tachycardia, pharyngitis, rhinitis, acne, pruritus, rash, urticaria, arthralgia, confusion, dysphonia, hyperkinesia, hypoesthesia, decreased libido, paresthesia, tremor, vertigo, flushing, postural hypotension, increased sweating, eye disorders, earache, tinnitus, taste abnormality, agitation, apathy, depression, euphoria, paroneiria, increased appetite, change in bowel habits, dyspepsia, eructation, hemorrhoids, tongue discoloration, tongue disorder, vomiting, transient abnormal hepatic function, dehydration, increased weight, hypertension, palpitation, migraine, bronchospasm, coughing, dyspnea, epistaxis, nasal congestion, sneezing, nasal irritation, dysuria, micturition disorder, nocturia, polyuria, urinary retention, asthenia, back pain, leg cramps, malaise and rigors.
During the marketing of loratadine, alopecia, anaphylaxis, tachycardia, palpitations, abnormal hepatic function, and dizziness have been reported rarely.
In clinical studies, the most frequently reported adverse events associated with Clarinase were headache and dry mouth. Less commonly reported events were somnolence and insomnia, which were reported also at a comparable rate with placebo and other new generation antihistamine controls.
Rarely reported events in decreasing order of frequency included dizziness, fatigue, anorexia, nervousness, nausea, epistaxis, hyperkinesia, constipation, dyspepsia, palpitation, tachycardia, thirst, agitation, irritability, coughing, dyspnoea, nasal irritation and pharyngitis.
With the exception of headache, which was occasionally severe, most of the adverse events associated with Clarinase were mild to moderate in severity.
During the marketing of loratadine, alopecia, anaphylaxis and abnormal hepatic function have been reported rarely.
There were rare post-marketing reports of mechanical upper GI tract obstruction in patients taking the original round tablet formulation of Clarinase. In many of these cases, patients have had a history of difficulty in swallowing tablets, or had known upper GI narrowing or abnormal oesophageal peristalsis.