Jastinda Adverse Reactions

Summary of safety profile: The most commonly reported adverse reactions with JASTINDA when used as oral contraceptive or when used in the treatment of moderate acne vulgaris in women electing to use oral contraception are nausea, breast pain, unscheduled uterine bleeding and genital tract bleeding not further specified. They occur in ≥ 3% of users. The most commonly reported adverse reactions with JASTINDA when used for the treatment of PMDD in women electing to use oral contraception are nausea, breast pain and unscheduled uterine bleeding. They occur in > 10% of users.
Serious adverse reactions are arterial and venous thromboembolism.
Tabulated summary of adverse reactions: The frequencies of ADRs reported in clinical trials with ethinylestradiol/drospirenone 0.02 mg/3 mg as oral contraceptives and ethinylestradiol/drospirenone 0.02 mg/3 mg in the treatment of moderate acne vulgaris in women who elect to use oral contraception (N=3565), as well as ethinylestradiol/drospirenone 0.02 mg/3 mg in the treatment of symptoms of PMDD in women who elect to use oral contraception (N= 289) are summarised in the table as follows. Within each frequency grouping, ADRs are presented in order of decreasing seriousness. Additional ADRs identified only during post marketing surveillance, and for which a frequency could not be estimated, are listed under 'not known'. (See Table 1.)

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Adverse reactions reported in women usinq COCs: 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): Tumours: 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 tumours (benign and malignant).
Other conditions: Erythema nodosum.
Increased risk of pancreatitis when using COCs in women suffering from hypertriglyceridemia (see Precautions).
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.
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.
Hypersensitivity (including symptoms such as rash, urticaria).
Other side effects that had been reported with the use of COCs that have neither been confirmed nor refuted are: (See Table 2.)

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Interactions: Breakthrough bleeding and/or contraceptive failure may result from interactions of other drugs (enzyme inducers) with oral contraceptives (see Interactions).