Crinone Adverse Reactions

The following definitions apply to the frequency terminology used hereafter: 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); Frequency not known (cannot be estimated from the available data.
Immune system disorders: Frequency not known: hypersensitivity reactions usually manifesting as skin rash e.g. generalized itchy skin rash, vulvovaginal swelling, swelling of the breasts and face.
Psychiatric disorders: Common: somnolence.
Gastrointestinal disorders: Common: abdominal pain/cramps.
Reproductive system and breast disorders: Common: breast tenderness, intermenstrual bleeding (spotting).
General disorders and administration site conditions: Common: headache, vaginal irritation and other mild application site reactions.
During post-marketing surveillance, clumping/coagulation/accumulation of Crinone gel has been reported. These events are usually non-serious and appear with beige to brownish clumpy or sometimes cloudy white discharge. The gel clumping/coagulation/accumulation can be associated with vaginal irritation, pain and swelling; very rarely, it might also cause cramps and vaginal bleeding.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorization 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.