Mirena Adverse Reactions

Undesirable effects are more common during the first months after the insertion, and subside during prolonged use.
Very common undesirable effects (occurring in more than 10% of users) include uterine/vaginal bleeding including spotting, oligomenorrhoea, amenorrhoea (see Pharmacology: Pharmacodynamics under Actions).
The frequency of benign ovarian cysts depends on the diagnostic method used (see Precautions) but has been estimated from clinical trial data to occur in 7% of users. (See Table 3.)

Click on icon to see table/diagram/image

Cases of sepsis (including group A streptococcal sepsis) have been reported following IUD insertion (see Precautions).
When a woman becomes pregnant with Mirena in situ, the relative risk of ectopic pregnancy is increased (see Precautions and Use in Pregnancy & Lactation).
Cases of breast cancer have been reported in Mirena users (see Precautions).
The following adverse reactions have been reported in connection with the insertion or removal procedure of Mirena: pain, bleeding and insertion-related vasovagal reaction with dizziness or syncope (see Precautions). The procedure may also precipitate a seizure in patients with epilepsy.
The removal threads may be felt by the partner during intercourse.
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 local reporting system.