The most commonly reported adverse reactions in long-term clinical trials of more than 9 cycles of treatment with drospirenone (2,700 women) were acne (3.8%), metrorrhagia (2.9%), headache (2.7%) and breast pain (2.2%).
Tabulated list of adverse reactions: Adverse reactions that have been reported in short- and long-term clinical trials with Slinda are listed in the table as follows.
All adverse reactions are listed by system organ class and frequency: 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). (See table.)
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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 listed in Appendix V.
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