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.
ADVERSE REACTIONS An increased risk of the following serious adverse reactions (see Warnings section for additional information) has been associated with the use of oral contraceptives: Serious cardiovascular events and stroke [see Boxed Warning ] Vascular events Liver disease Adverse reactions commonly reported by COC users are: Irregular uterine bleeding Nausea Breast tenderness Headache 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 rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The safety of Turqoz was evaluated in 1,343 healthy women of child-bearing potential who participated in 9 clinical trials and received at least one dose of Turqoz for contraception.
Subjects were exposed for a total of 11,085 cycles, with 429 women completing one year of exposure.
Subjects ranged in age from 15 to 40 years.
Demographics were 69 % Caucasian, 28 % Black, and 3 % other.
Common Adverse Reactions (≥ 2 % of women) Weight increase (11 %) Cervical erosion (9 %) Weight decrease (6 %) Acne (4 %) Dysmenorrhea (4 %) Vaginal discharge (4 %) Abdominal pain, cramps, and bloating (3 %) Appetite increase (3 %) Depression (3 %) Nervousness (3 %) Chloasma/melasma (2 %) Fatigue (2 %) Varicose veins, aggravation of (2 %) A total of 8% of subjects discontinued the trials prematurely due to an adverse reaction, most commonly due to unscheduled bleeding, spotting, headache (including migraine), nausea, acne, changes in menstrual flow, weight increase, nervousness, high blood pressure, and depression.
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 to 1.12 (Figure 1).
Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 1).
One of these studies reported no association between breast cancer risk and COC use.
The other two studies found an increased relative risk of 1.19 to 1.33 with current or recent use.
Thromboembolic Disorders and Other Vascular Problems Stop Turqoz if an arterial thrombotic event or venous thromboembolic (VTE) event occurs.
Stop Turqoz if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions.
Evaluate for retinal vein thrombosis immediately.
If feasible, stop Turqoz at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE as well as during and following prolonged immobilization.
Start Turqoz no earlier than 4 weeks after delivery, in women who are not breastfeeding.
Like all medications, Turqoz 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: