Diane 35 Adverse Reactions

Summary of safety profile: The most commonly reported adverse reactions with Diane 35 are nausea, abdominal pain, increased weight, headache, depressed mood, altered mood, breast pain, breast tenderness. They occur in ≥ 1 % of users.
Serious adverse reaction is thromboembolism.
Tabulated list of adverse reactions: Side effects that have been reported in users of COCs but for which the association has been neither confirmed nor refuted are: See table.

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Description of selected adverse reactions: Adverse reactions with very low frequency or with delayed onset of symptoms which are considered to be related to the group of combined oral contraceptives are listed as follows (see also Contraindications, Precautions): Tumors: The frequency of diagnosis of breast cancer is very slightly increased among OC users. As breast cancer is rare in women under 40 years of age the excess number is small in relation to the overall risk of breast cancer. Causation with COC use is unknown; Liver tumors (benign and malignant).
Other conditions: Venous thromboembolic disorders; Arterial thromboembolic disorders; Cerebrovascular accidents; Increased risk of pancreatitis when using COCs (women with hypertriglyceridemia); Hypertension. Occurrence or deterioration of conditions for which association with COC use is not conclusive: jaundice and/or pruritus related to cholestasis; gallstone formation; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; Sydenham's chorea; herpes gestationis; otosclerosis-related hearing loss, cervical cancer. In women with hereditary angioedema exogenous estrogens may induce or exacerbate symptoms of angioedema; Liver function disturbances; Changes in glucose tolerance or effect on peripheral insulin resistance; Crohn's disease, ulcerative colitis; Chloasma.
Interactions: Breakthrough bleeding and/or contraceptive failure may result from interactions of other drugs (enzyme inducers) with oral contraceptives (see Interactions).