Enantone L.P. Adverse Reactions

The following convention is used for the classification of the frequency of an adverse drug reaction (ADR) and is based on the Council for International Organizations of Medical Sciences (CIOMS) guidelines: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
All Patient Populations: See Table 3.

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All Adult Populations: See Table 4.

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Adult Males: In the initial phase of therapy, a short-term increase, also known as a flare-up, of the sex hormone level occurs (flare phenomenon). Adverse events, which may occur particularly at the beginning of treatment, include urinary tract obstruction (as urinary symptoms); In patients with spinal cord compression, bone pain, weakness of lower extremities and paresthesia (as neurologic symptoms) may also occur (see Precautions). (See Table 5.)

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3.75 mg/11.25 mg: Adult Females: See Table 6.

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Additional ADRs in Breast Cancer Patients or at Differing Frequency: See Table 7.

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Additional ADRs in Endometriosis/Uterine Fibroids Patients or at Differing Frequency: See Table 8.

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Pediatric Patients: In the initial phase of therapy, a short-term increase, also known as a flare-up, of the sex hormone level occurs, followed by a decrease to values within the pre-pubertal range. Due to this pharmacological effect, adverse events may occur particularly at the beginning of treatment. (See Table 9.)

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