Amethia Side Effects

ADVERSE REACTIONS The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling: Serious cardiovascular events and smoking [see Boxed Warning and Warnings and Precautions (5.1) ] Vascular events [see Warnings and Precautions (5.1) ] Liver disease [see Warnings and Precautions (5.3) ] Adverse reactions commonly reported by COC users are: Irregular uterine bleeding Nausea Breast tenderness Headache The most common adverse reactions (≥5%) in clinical trials for levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets are irregular and/or heavy uterine bleeding, weight gain, and acne.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma.

at 1-844 -825-8500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The clinical trial that evaluated the safety and efficacy of levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets was a 12-month, randomized, multicenter, open-label study, which enrolled women aged 18-40, of whom 1,006 took at least one dose of levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets.

Adverse Reactions Leading to Study Discontinuation : 16.3% of the women discontinued from the clinical trial due to an adverse reaction;

the most common adverse reactions (≥ 1% of women) leading to discontinuation were irregular and/or heavy uterine bleeding (5.9%), weight gain (2.4%), mood changes (1.5%), and acne (1.0%).

Common Treatment-Emergent Adverse Reactions (≥ 5% of women) : irregular and/or heavy uterine bleeding (17%), weight gain (5%), acne (5%).

Serious Adverse Reactions: migraine, cholecystitis, cholelithiasis, pancreatitis, abdominal pain, and major depressive disorder.

6.2 Postmarketing Experience Five studies that compared breast cancer risk between ever-users (current or past use) of COCs and never-users of COCs reported no association between ever use of COCs and breast cancer risk, with effect estimates ranging from 0.90–1.12 (Figure 2).