What are the possible side effects of IMCIVREE?
IMCIVREE was well studied and most side effects were generally mild and improved over time
The safety of IMCIVREE has been evaluated over ~10 years of clinical trials.
The most common side effects in people with obesity and a clinical diagnosis of BBS included:
- Darkening of the skin* (63%)
- Injection site reactions (51%)
- Nausea (26%)
- Erection that happens without any sexual activity in males (25%)
- Vomiting (19%)
- Diarrhea (14%)
- Headache (7%)
- Stretch marks (7%)
- Aggression (5%)
- Fatigue (5%)
Most nausea and vomiting events were mild, and none were severe. Nausea and vomiting primarily occurred within the first month of treatment and then sharply declined. These symptoms typically lasted no more than a few days.
No serious side effects were reported related to IMCIVREE in the BBS trial.
Contact your doctor if you are experiencing side effects.
A general darkening of the skin was common and rarely led to a stop in treatment
After stopping IMCIVREE
Example of hyperpigmentation
- IMCIVREE may also lead to increased production of melanin (which gives color to your skin)
- This usually occurs within the first month of starting IMCIVREE
- Darkening of the skin may vary
- IMCIVREE can cause darkening of existing skin growths, such as moles
- You should have a full-body skin exam before starting and during treatment with IMCIVREE to check for skin changes.
- No cases of melanoma have been reported in connection with the administration of IMCIVREE in any of the clinical trials, which included more than 500 people
- Changes in skin color went away when treatment with IMCIVREE was stopped
These are not all the possible side effects of IMCIVREE. Please review all the possible side effects of IMCIVREE included in the Patient Information and talk to your doctor about any questions you may have.