Delsia Adverse Reactions

The following serious adverse reactions have been reported with the use of COCs: Serious cardiovascular events and stroke (see PRECAUTIONS); Vascular events (see PRECAUTIONS); Liver disease (see PRECAUTIONS).
Adverse reactions commonly reported by COC users are: Irregular uterine bleeding; Nausea; Breast tenderness; Headache.
Clinical Trials Experience: The most common adverse reactions (≥ 2% of users) reported were: premenstrual syndrome (13.2%), headache/migraine (10.7%), breast pain/tenderness/discomfort (8.3%), nausea/vomiting (4.5%), abdominal pain/discomfort/tenderness (2.3%) and mood changes (depression, depressed mood, irritability, mood swings, mood altered and affect lability) (2.3%).
Adverse Reactions (≥ 1%) Leading to Study Discontinuation: 6.7% discontinued from the reported clinical studies due to an adverse reaction; the most frequent adverse reaction leading to discontinuation was reported to be headache/migraine (1.5%).
Serious Adverse Reactions: Depression, pulmonary embolism, toxic skin eruption, and uterine leiomyoma.
Post-marketing Experience: The following adverse reactions have been reported during post-approval use of drospirenone 3 mg and ethinyl estradiol 0.03 mg combination. 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.
Adverse reactions, including fatalities, are grouped into System Organ Classes and ordered by frequency.
Vascular disorders: Venous and arterial thromboembolic events (including pulmonary emboli, deep vein thrombosis, intracardiac thrombosis, intracranial venous sinus thrombosis, sagittal sinus thrombosis, retinal vein occlusion, myocardial infarction and stroke), hypertension.
Hepatobiliary disorders: Gallbladder disease.
Immune system disorders: Hypersensitivity.
Metabolism and nutrition disorders: Hyperkalemia.
Skin and subcutaneous tissue disorders: Chloasma.