What are the side effects of the Diane/Juliet-35 ED contraceptive pill?

Adverse Effects Serious undesirable effects of Diane-35 have been referred to in the contraindications and warnings and precautions sections.

The following undesirable effects have been reported in users of Diane-35 and the association has been neither confirmed nor refuted:

Breast tenderness, pain, secretion; headache; migraine; changes in libido; depressive moods; contact lens intolerance; nausea; vomiting; changes in vaginal secretion; various skin disorders; fluid retention; change in body weight; hypersensitivity reaction.

Interactions Drug interactions which result in an increased clearance of sex hormones can lead to breakthrough bleeding and oral contraceptive failure. This has been established with hydantoins, barbiturates, primidone, carbamazepine and rifampicin; oxcarbamazepine, topiramate, felbamate and griseofulvin are also suspected. The mechanism of this interaction appears to be based on the hepatic enzyme-inducing properties of these drugs. Maximal enzyme induction is generally not seen for 2-3 weeks but may then be sustained for at least 4 weeks after the cessation of drug therapy.

Contraceptive failures have also been reported with antibiotics, such as ampicillins and tetracyclines. The mechanism of this effect has not been elucidated.

Women on short-term treatment with any of the above-mentioned classes of drugs or individual drugs should temporarily use a barrier method in addition to the DIANE-35, I.e. during the time of concomitant drug administration and for 7 days after their discontinuation. For women on rifampicin, a barrier method should be used in addition to the DIANE-35 during the time of rifampicin administration and for 28 days after its discontinuation. If concomitant drug administration runs beyond the end of the tablets in the DIANE-35 pack, the next DIANE-35 pack should be started without the usual tablet-free interval.

In women on long-term treatment with hepatic enzyme-inducing drugs, experts have recommended to increase the contraceptive steroid doses. If a high contraceptive dosage is not desirable or appears to be unsatisfactory or unreliable, e.g. in the case of irregular bleeding, another method of contraception should be advised.

Warnings and Precautions The clinical and epidemiological experience with estrogen/progestogen combinations like DIANE-35 is predominantly based on combined oral contraceptives (COC). Therefore, the following warnings related to the use of COC apply also for DIANE-35.

If any of the conditions/risk factors mentioned below is present, the benefits of the use of DIANE-35 should be weighed against the possible risks for each individual woman and discussed with the woman before she decides to start using it. In the event of aggravation, exacerbation or first appearance of any of these conditions or risk factors, the woman should contact her physician. The physician should then decide on whether its use should be discontinued.

Reduced efficacy The efficacy of DIANE-35 may be reduced in the event of missed tablets, vomiting or concomitant medication.

Reduced cycle control With estrogen/progestogen combinations, irregular bleeding (spotting or breakthrough bleeding) may occur, especially during the first months of use. Therefore, the evaluation of any irregular bleeding is only meaningful after an adaptation interval of about three cycles.

If bleeding irregularities persist or occur after previously regular cycles, then non-hormonal causes should be considered and adequate diagnostic measures are indicated to exclude malignancy or pregnancy. These may include curettage.

In some women withdrawal bleeding may not occur during the tablet-free interval. If the COC has been taken according to the suggested directions, it is unlikely that the woman is pregnant. However, if the COC has not been taken according to these directions prior to the first missed withdrawal bleed or if two withdrawal bleeds are missed, pregnancy must be ruled out before COC use is continued.