Olmetec Adverse Reactions

Summary of the safety profile: The most commonly reported adverse reactions during treatment with Olmetec are headache (7.7%), influenza-like symptoms (4.0%) and dizziness (3.7%).
In placebo-controlled monotherapy studies, the only adverse drug reaction that was unequivocally related to treatment was dizziness (2.5% incidence on olmesartan medoxomil and 0.9% on placebo).
The incidence was also somewhat higher on olmesartan medoxomil compared with placebo for hypertriglyceridaemia (2.0% versus 1.1%) and for raised creatine phosphokinase (1.3% versus 0.7%).
Tabulated list of adverse reactions: Adverse reactions from Olmetec in clinical trials, post-authorisation safety studies and spontaneous reporting are summarized in the following table.
The following terminologies have been used in order to classify the occurrence of adverse reactions: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000). (See table.)

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Single cases of rhabdomyolysis have been reported in temporal association with the intake of angiotensin II receptor blockers.
Additional information on special populations: Paediatric population: The safety of olmesartan medoxomil was monitored in 361 children and adolescents, aged 1-17 years old during 2 clinical trials. Whilst the nature and severity of the adverse events are similar to that of the adults, the frequency of the following is higher in the children: Epistaxis is a common adverse event in children (i.e. ≥1/100 to <1/10) that has not been reported in adults.
During the 3 weeks of double blind study, the incidence of treatment emergent dizziness and headache nearly doubled in children 6-17 years of age in the high olmesartan medoxomil dose group.
The overall safety profile for olmesartan medoxomil in paediatric patients does not differ significantly from the safety profile in adults.
Elderly (age 65 years or over): In elderly people the frequency of hypotension is slightly increased from rare to uncommon.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via [the national reporting system].