BALCOLTRA SIDE EFFECTS
- Generic Name: levonorgestrel and ethinyl estradiol and ferrous bisglycinate tablets
- Brand Name: Balcoltra
- Drug Class: Contraceptives, Oral
SIDE EFFECTS
The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:
- Serious cardiovascular events and stroke
- Vascular events
- Liver disease
Adverse reactions commonly reported by COC users:
- 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.
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At the time of the report, 133 (9%) subjects had withdrawn from the study due to adverse events.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.
Postmarketing Experience
The following additional adverse drug reactions have been reported from worldwide postmarketing experience with levonorgestrel 0.1 mg and ethinyl estradiol 0.02 mg tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cardiac disorder: chest pain, dyspnea, palpitations
Gastrointestinal disorders: abdominal pain, nausea, vomiting, diarrhea
General disorders and administration site conditions: chest pain, fatigue, pain, malaise, injection site pain or erythema, feeling abnormal, pyrexia, condition aggravated, asthenia
Immune system disorders: hypersensitivity reactions, including pruritus, rash, urticaria, erythema
Injury, poisoning, and procedural complications: injury
Investigations: weight decreased
Musculoskeletal and connective tissue disorders: pain in extremity, arthralgia, back pain, muscle spasm
Nervous system disorders: headache, migraine, dizziness, hypoesthesia, paresthesia
Psychiatric disorders: depression, insomnia, anxiety
Reproductive system and breast disorders: metrorrhagia, menorrhagia, hot flush, vaginal hemorrhage
Respiratory, thoracic, and mediastinal disorders: nasopharyngitis, cough
Sleep disorders and disturbances: somnolence
Vascular disorders: deep vein thrombosis, pulmonary embolism.
SRC: NLM .