Injectafer: Side Effects, Risks & Lawsuit Information

Injectafer (ferric carboxymaltose) is an iron replacement product administered as an intravenous (IV) infusion. It is injected into your veins to treat iron deficiency anemia (IDA). This is a condition where there’s not enough iron in your blood.

Despite receiving U.S. Food and Drug Administration (FDA) approval in 2013, Injectafer carries serious health risks. Patients have filed lawsuits against Injectafer’s manufacturer, Daiichi Sankyo, due to dangerous side effects they’ve experienced.

The legal cases around Injectafer aren’t about whether it works, but rather whether the risks associated with its use were fully disclosed to patients and health care providers.

Injectafer clinical trials found that some of the most common side effects included headache, nausea and redness of the skin. Many side effects are considered mild and usually go away within 30 minutes after infusion.

Other reported side effects include abdominal pain, diarrhea, sneezing and unusual sensations in the skin like tingling, burning or numbness.

Serious Injectafer side effects include allergic reactions, high blood pressure and iron overload. Other rare but serious side effects include hypophosphatemia and long-term bone problems.

Injectafer can also interfere with certain tests, like overestimating serum iron.

Allergic Reactions

Rarely, patients who take Injectafer may suffer from serious, life-threatening allergic reactions known as hypersensitivity reactions. Symptoms can include low blood pressure, shock and loss of consciousness. Hives, itchiness, rash and wheezing may also occur.

After receiving an infusion, health care providers will monitor you for at least 30 minutes to watch for signs of a reaction. Injectafer’s label also specifies that the infusion should only be given if treatment is immediately available for hypersensitivity reactions.

High Blood Pressure

Roughly 4% of patients who received Injectafer during clinical trials reported high blood pressure, sometimes accompanied by dizziness, facial flushing or nausea. This typically resolves within 30 minutes.

However, some cases may progress to a hypertensive crisis. This is when you have extremely high blood pressure that can be life-threatening. Immediate medical intervention is required if this happens.

Medical providers will monitor you for signs of high blood pressure after your Injectafer infusion. If you have high blood pressure, inform your doctor before taking Injectafer.

Iron Overload

Receiving excessive doses of Injectafer may lead to iron overload. This is when there is too much iron in your body. Iron overload can increase your risk of diabetes, chronic liver failure and congestive heart failure.

Tell your doctor if you experience the following symptoms while on Injectafer, as these may indicate iron overload:

• Abdominal pain
• Chronic fatigue
• Joint pain
• Skin darkening
• Unexplained weight loss

Symptomatic Hypophosphatemia

In February 2020, Injectafer’s manufacturer added a warning to the drug’s label for symptomatic hypophosphatemia. This is a condition characterized by abnormally low phosphate levels of less than 2.5 mg/dl.

Phosphate is a mineral you need for healthy bones, teeth, nerve and muscle function. Mild cases of hypophosphatemia don’t usually have symptoms.

In more serious cases, you may experience:

Studies have found that those who receive multiple doses of Injectafer are more likely to experience prolonged hypophosphatemia. Additionally, researchers have found that Injectafer is more likely to cause hypophosphatemia than other iron replacements.

Bone Problems

Bone problems are a long-term danger that accompanies hypophosphatemia. You may experience joint and bone pain due to phosphate depletion.

Additionally, if you have long-term or severe phosphate depletion, you may experience fractures or softening of your bones.

Alert your doctor if you experience any of the following while taking Injectafer:

• Bone or joint pain
• Broken bones
• Muscle pain or weakness
• Tiredness

The FDA has given Injectafer multiple approvals over the years. However, thousands of adverse event reports have been reported to the FDA’s Adverse Events Reporting System (FAERS). Label updates highlighting the drug’s dangers have also been added.

As of November 2025, voluntary reports to FAERS list 8,324 total adverse events related to Injectafer and ferric carboxymaltose. These include 6,180 serious reactions and 219 deaths.

In February 2020, Injectafer’s label was updated to include “symptomatic hypophosphatemia requiring clinical intervention” in its warnings section.

The label also states that certain conditions increase your risk, like a vitamin D deficiency, malnutrition, gastrointestinal disorders that reduce absorption, conditions affecting kidney tubules and hyperparathyroidism.

For patients who have received recent Injectafar infusions, health care providers are advised to check phosphate levels before repeating the treatment.

Patients who received Injectafer and developed hypophosphatemia are suing the manufacturer. Injectafer lawsuits claim that the manufacturer knew about the risk of hypophosphatemia but did not properly disclose it to doctors or patients.

Allegations include:

• Failure to warn: Plaintiffs claim that Daiichi Sanyko and its associates failed to adequately warn users about the risk of hypophosphatemia despite knowing about the danger.
• Corporate negligence: Litigation alleges that the defendants marketed, advertised and promoted Injectafer as safe and superior to other iron injection drugs on the market.

The first Injectafer lawsuit was filed in 2019. Multiple lawsuits have been filed by patients, with some being consolidated into a mini-multidistrict litigation (MDL) in the Eastern District of Pennsylvania. These cases were settled, but the details were not publicized.

Other lawsuits are pending, and attorneys are still accepting cases from patients who were harmed by Injectafer.

Many people considering Injectafer also consider alternatives, such as Venofer or Feraheme. Here’s how they compare.

Injectafer’s elevated risk of hypophosphatemia compared to other IV iron replacement products and the manufacturer’s failure to properly convey this risk led patients to file lawsuits.

If you’re using or have used Injectafer and believe it harmed you, seek immediate medical care. Document all your treatments and any diagnoses you receive, then consider pursuing legal options.

If you are taking Injectafer or have been injured while taking the product, resources are available to help you learn about safety and potential lawsuits. These include: