From the Guidelines
Oralcone 30, a combined oral contraceptive (COC) containing 30 μg of ethinyl estradiol, can cause several side effects, including irregular bleeding, headache, and nausea, as well as more serious adverse effects such as an increased risk of blood clots, with a risk increase from 1 per 10,000 to 3 to 4 per 10,000 woman-years during COC use 1. The most common side effects of Oralcone 30 are:
- Irregular bleeding
- Headache
- Nausea
- Breast tenderness These side effects are usually transient and tend to resolve over the first 2-3 cycles of use 1. More serious adverse effects associated with Oralcone 30 include:
- Increased risk of blood clots (thromboembolic events)
- Increased risk of cardiovascular events (approximately 2 per 10,000 person-years) and ischemic stroke (approximately 1 per 25,000 person-years) However, it's essential to note that the attributable risk for these events is low in otherwise healthy women 1. To minimize side effects and risks, patients should be counseled on the proper use of Oralcone 30, including taking the medication as directed, attending regular follow-up appointments, and reporting any concerning symptoms to their healthcare provider promptly 1. Additionally, patients should be informed about the non-contraceptive benefits of Oralcone 30, such as regulation of the menstrual cycle, reduction of menorrhagia and associated anemia, and a decreased risk of certain cancers, including colorectal, ovarian, and endometrial cancers 1.
From the FDA Drug Label
ADVERSE REACTIONS An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS section): Thrombophlebitis and venous thrombosis with or without embolism Arterial thromboembolism Pulmonary embolism Myocardial infarction Cerebral hemorrhage Cerebral thrombosis Hypertension Gallbladder disease Hepatic adenomas or benign liver tumors The following adverse reactions have been reported in users of oral contraceptives and the association has been neither confirmed nor refuted: Pre-menstrual syndrome Cataracts Changes in appetite Cystitis-like syndrome Headache Nervousness Dizziness Hirsutism Loss of scalp hair Erythema multiforme Erythema nodosum Hemorrhagic eruption Vaginitis Porphyria Impaired renal function Hemolytic uremic syndrome Acne Changes in libido Colitis Budd-Chiari syndrome
The side effects of oral contraceptives, such as thrombophlebitis, venous thrombosis, arterial thromboembolism, pulmonary embolism, myocardial infarction, cerebral hemorrhage, and cerebral thrombosis, have been reported. Other possible side effects include:
- Hypertension
- Gallbladder disease
- Hepatic adenomas or benign liver tumors
- Pre-menstrual syndrome
- Cataracts
- Changes in appetite
- Cystitis-like syndrome
- Headache
- Nervousness
- Dizziness
- Hirsutism
- Loss of scalp hair
- Erythema multiforme
- Erythema nodosum
- Hemorrhagic eruption
- Vaginitis
- Porphyria
- Impaired renal function
- Hemolytic uremic syndrome
- Acne
- Changes in libido
- Colitis
- Budd-Chiari syndrome 2 2
From the Research
Side Effects of Oral Contraceptives
The side effects of oral contraceptives can be minimized by appropriate selection of the contraceptive formulation 3. Some common side effects include:
- Weight gain
- Breakthrough bleeding (BTB)
- Nausea
- Headache
- Breast tenderness
- Mood swings
- Acne
- Hirsutism
Minimizing Side Effects
The relative androgenicity of the progestin component of combination oral contraceptives has become an important factor in selecting formulations to minimize side effects 3. Preparations with less androgenic potential can minimize some physical side effects and adverse metabolic effects.
Specific Side Effects
- Acne and hirsutism can be eliminated or improved by using oral contraceptives with low androgenic activity 3.
- Weight gain is not significantly affected by the formulation of the oral contraceptive, although it may be partially androgen-related 3.
- Breakthrough bleeding is related to the dose, potency, and ratio of estrogen and progestin in the formulation, and usually subsides within a few months 3.
- Nausea and breast tenderness are primarily estrogen-related effects, and switching to a formulation with a lower dose of estrogen may be beneficial 3.
- Mood changes are a common complaint, but their relationship to oral contraceptive use is difficult to assess 3.
Non-Contraceptive Benefits
Oral contraceptives can have non-contraceptive benefits, including: