FDA Adds Boxed Warning to Injectafer Over Low Phosphate Risk
The FDA has added a boxed warning to the anemia drug Injectafer due to risk of symptomatic hypophosphatemia.
4 reports on this incident · first at Sep 2, 2026, 7:10 a.m. ET
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Earlier reports
Sep 2, 2026, 7:21 a.m. ET
FDA Adds Boxed Warning to Injectafer Over Low Phosphate Risk
The U.S. Food and Drug Administration has added a boxed warning to the anemia drug Injectafer (ferric carboxymaltose injection) over the risk of symptomatic hypophosphatemia, or dangerously low levels of phosphate in the blood, according to Medical Daily.
The agency advises patients not to stop or delay treatment on their own and to immediately report new or worsening symptoms of low phosphate to a health care professional. Reported symptoms include muscle weakness or pain, fatigue, tremors, confusion, seizures and cardiac arrhythmias.
Sep 2, 2026, 7:16 a.m. ET
FDA Adds Boxed Warning to Injectafer Over Low Phosphate Risk
The U.S. Food and Drug Administration has added a boxed warning to the anemia drug Injectafer (ferric carboxymaltose injection) due to the risk of symptomatic hypophosphatemia, or dangerously low levels of phosphate in the blood, according to a report from Medical Daily.
The agency stated that reported symptoms include muscle weakness or pain, fatigue, tremors, confusion, seizures and cardiac arrhythmias. The FDA advises patients not to stop or delay treatment on their own, and to immediately report new or worsening symptoms of low phosphate to a health care professional.
Sep 2, 2026, 7:10 a.m. ETFirst report
FDA Adds Boxed Warning to Injectafer Over Low Phosphate Risk
The U.S. Food and Drug Administration has added a boxed warning to Injectafer (ferric carboxymaltose injection) over the risk of symptomatic hypophosphatemia, which can lead to dangerously low levels of phosphate in the blood, according to a report by Medical Daily.
The warning follows reports of symptoms including muscle weakness or pain, fatigue, tremors, confusion, seizures, and cardiac arrhythmias. The FDA advises patients not to stop or delay treatment on their own and to immediately report new or worsening symptoms of low phosphate to a health care professional.
The cause of the condition is under investigation, and the FDA has not determined a definitive cause for the reported cases.
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Revision history
- Version 12 Sept 2026, 11:22current
First published.
- Version 12 Sept 2026, 11:10current
First published.
- Version 12 Sept 2026, 11:16current
First published.
- Version 12 Sept 2026, 11:21current
First published.
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