Implanon NXT

Implanon NXT Adverse Reactions





Zuellig Pharma
Full Prescribing Info
Adverse Reactions
Serious undesirable effects: See Warnings under Precautions.
Other possible undesirable effects: During the use of Implanon NXT, women are likely to have changes in their menstrual bleeding pattern. These may include changes in bleeding frequency (absent, less, more frequent or continuous), intensity (reduced or increased) or duration. Amenorrhea was reported in about 1 of 5 women while another 1 of 5 women reported frequent and/or prolonged bleeding. Occasionally, heavy bleeding has been reported. In clinical trials, bleeding changes were the most common reason for stopping treatment (about 11%). Dysmenorrhea tended to improve while using Implanon NXT. The bleeding pattern experienced during the first three months is broadly predictive of future bleeding patterns for many women.
Possibly related undesirable effects reported in clinical trials have been listed in the table as follows. (See table.)

Click on icon to see table/diagram/image

In a clinical trial of Implanon NXT, in which investigators were asked to examine the implant site after insertion, implant site reactions were reported in 8.6% of women. Erythema was the most frequent implant site complication, reported during and/or shortly after insertion, occurring in 3.3% of subjects. Additionally, hematoma (3.0%), bruising (2.0%), pain (1.0%), and swelling (0.7%) were reported.
During post marketing surveillance, a clinically relevant rise in blood pressure has been observed in rare cases. Seborrhea has also been reported. Anaphylactic reactions, urticaria, angioedema, aggravation of angioedema and/or aggravation of hereditary angioedema may occur.
Insertion or removal of the implant may cause some vasovagal reactions (for example: hypotension, dizziness, or syncope), bruising, slight local irritation, pain or itching. Fibrosis at the implant site may occur, a scar may be formed or an abscess may develop. Paresthesia or paresthesia-like events may occur. Expulsion or migration of the implant have been reported, including rarely to the chest wall. In rare cases, implants have been found within the vasculature including the pulmonary artery. Some cases of implants found within the pulmonary artery reported chest pain and/or respiratory disorders (such as dyspnea, cough or hemoptysis); others have been reported as asymptomatic (see also Warnings under Precautions). Surgical intervention might be necessary when removing the implant.
On rare occasions, ectopic pregnancies have been reported (see Warnings under Precautions).
In women using (combined oral) contraceptives a number of (serious) undesirable effects have been reported. These include venous thromboembolic disorders, arterial thromboembolic disorders, hormone-dependent tumours (e.g. liver tumours, breast cancer) and chloasma, some of which are discussed in more detail in Precautions.
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