Glossary

Injectafer (Ferric Carboxymaltose)

An intravenous iron drug used to treat iron deficiency anemia. In September 2026 the FDA added a boxed warning about the risk of severe low phosphate levels.

Injectafer is the brand name for ferric carboxymaltose, an iron replacement given by IV infusion. Doctors use it for adults with iron deficiency anemia who cannot tolerate oral iron or did not respond to it, and for some patients with chronic kidney disease or heart failure. It became popular because a full course can be given in fewer, larger doses than some older IV iron products.

The main safety issue is hypophosphatemia, a drop in blood phosphate that can cause fatigue, muscle weakness, bone pain, and in some patients fractures from softened bones. On September 1, 2026, the FDA announced a new boxed warning for Injectafer describing the risk of symptomatic hypophosphatemia and recommending phosphate monitoring for at-risk patients and those who receive repeat courses. The FDA said it acted because reports kept arriving despite label changes in February 2020 and May 2023.

Lawsuits against the drug's makers allege they did not adequately warn doctors and patients about how severe and long-lasting the phosphate drop could be. Federal cases have been handled in the Eastern District of Pennsylvania, and each claim is an individual injury case rather than a class action. A claim usually depends on infusion records, blood tests showing low phosphate after treatment, and records of symptoms or fractures.

No one should stop or skip a prescribed treatment because of a lawsuit; talk to your doctor about monitoring. For how drug injury cases work, see class actions versus mass torts and how long these lawsuits take.

Sources.

Statutes, court rules, appellate opinions, and bar publications we relied on. See our editorial standards.

  1. 1.FDA Drug Safety Communication: Boxed Warning for Ferric Carboxymaltose Injection (Injectafer), September 1, 2026