BALCOLTRA SIDE EFFECTS

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At the time of the report, 133 (9%) subjects had withdrawn from the study due to adverse events.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 .