Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling: Serious cardiovascular events and stroke [see Boxed Warning and Warnings and Precautions ( 5.1 )] Vascular events [see Warnings and Precautions ( 5.1 )] Liver disease [see Warnings and Precautions ( 5.2 )] Adverse reactions commonly reported by COC users are: Irregular uterine bleeding Nausea Breast tenderness Headache Common adverse reactions (≥2% of women): headache (14%), metrorrhagia (8%), dysmenorrhea and nausea (7% each), abdominal pain and breast pain (4% each), emotional lability and acne (3% each), and depression, amenorrhea, and vaginal moniliasis (2% each) ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc.
at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials 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 clinical practice.
In a clinical trial with levonorgestrel 0.1 mg and ethinyl estradiol 0.02 mg tablets, a total of 1477 healthy women of child-bearing potential were enrolled and had 7870 cycles of exposure.
Of these, 792 subjects had completed 6 cycles of treatment.
The women ranged in age from 17 to 49 years and 87% were Caucasian.
Common Adverse Reactions (≥ 2% of women) headache (14%) metrorrhagia (8%) dysmenorrhea (7%) nausea (7%) abdominal pain (4%) breast pain (4%) emotional lability (3%) acne (3%) depression (2%) amenorrhea (2%) vaginal moniliasis (2%) At the time of the report, 133 (9%) subjects had withdrawn from the study due to adverse events.
The most frequent were due to headache and metrorrhagia (1% each).
Other adverse events occurring in <1% of those who discontinued included amenorrhea, depression, emotional lability, hypertension, acne, menorrhagia, nausea, hypercholesterolemia, weight gain, dysmenorrhea, and flatulence.
All other reasons for discontinuation were reported by 3 or fewer subjects.
5 WARNINGS AND PRECAUTIONS Thrombotic Disorders and Other Vascular Problems : Stop Minzoya if a thrombotic event occurs.
Stop at least 4 weeks before through 2 weeks after major surgery.
Start no earlier than 4 weeks after delivery, in women who are not breastfeeding ( 5.1 ) Liver disease : Discontinue Minzoya if jaundice occurs ( 5.2 ) High Blood Pressure : If used in women with well- controlled hypertension, monitor blood pressure and stop Minzoya if blood pressure rises significantly.
( 5.4 ) Carbohydrate and Lipid Metabolic Effects : Monitor prediabetic and diabetic women taking Minzoya.
Consider an alternative contraceptive method for women with uncontrolled dyslipidemia ( 5.6 ) Headache : Evaluate significant change in headaches and discontinue Minzoya if indicated ( 5.7 ) Bleeding Irregularities and Amenorrhea : Evaluate irregular bleeding or amenorrhea ( 5.8 ) 5.1 Thrombotic Disorders and Other Vascular Problems Stop levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets if an arterial thrombotic event or venous thromboembolic (VTE) event occurs.
Like all medications, Minzoya can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: