The FDA approved a higher-dose version of the weight-loss drug Wegovy on March 19. The new formulation, called Wegovy HD, delivers 7.2 mg of semaglutide by weekly injection, up from the previous 2.4 mg weekly dose.
Novo Nordisk developed the higher dose after trials showed some people did not reach therapeutic goals at 2.4 mg. In the 2025 STEP UP phase 3b trial, the 7.2 mg dose produced an average weight loss of 18.7%, and about one in three participants lost at least 25% of their body weight. The FDA said the approval was supported by clinical data showing a safety profile consistent with the known effects of semaglutide.
FDA Commissioner Martin Makary noted the agency’s expedited action on products tied to national priorities. Clinicians express cautious optimism: Meghan Garcia-Webb, MD, who was not involved in the trial, said serious adverse events were slightly lower in the 7.2 mg group in trial data, but real-world monitoring will be important.
Common side effects of Wegovy are gastrointestinal and generally include nausea, diarrhea, constipation, vomiting, and abdominal pain. Reports of altered skin sensations—sensitivity, pain, or burning—occurred more often at higher doses. These side effects usually resolve over time or with dose reduction; patients often experience a flare when a dose is increased that improves over weeks to months.
Recent research raised concerns about a higher risk of ischemic optic neuropathy (ION, sometimes called “eye stroke”) with higher semaglutide doses, particularly in males. ION can cause sudden vision loss; the increased risk may relate to greater systemic exposure and faster weight loss affecting optic nerve blood flow. Because FDA adverse-event reporting is voluntary, the true incidence is unclear, but the pattern suggests clinicians should monitor patients closely, especially those on higher doses or with pre-existing eye conditions. Garcia-Webb recommends checking with an ophthalmologist before starting high-dose semaglutide if there are eye concerns.
Wegovy’s listed common side effects include:
– Nausea, upset stomach, or vomiting
– Diarrhea or constipation
– Headache or dizziness
– Stomach pain
– Fatigue
– Bloating, belching, or gas
– Heartburn
– Runny nose or sore throat
– Low blood sugar in people with type 2 diabetes
These effects are generally mild; discuss persistent or bothersome symptoms with a healthcare professional. Other considerations include cost and the likelihood that long-term use may be required to maintain weight loss and its health benefits.