Injectafer Side Effects

Clinical trials studied its safety and effectiveness in 1,775 patients who received Injectafer, according to the drug’s prescribing information. Researchers considered a side effect common if it occurred in 2% or more of patients.

Voluntary reports to the FDA Adverse Events Reporting System (FAERS) list 4,858 total adverse event cases related to Injectafer and ferric carboxymaltose — including 3,411 serious reactions and 138 deaths as of March 31, 2021.

The three top-reported side effects in FAERS are nausea, headache and itchiness.

Serious Injectafer side effects include allergic reactions, high blood pressure and iron overload. Other rare but serious side effects reported include rash, fainting and muscle aches.

Allergic Reactions

Rarely, patients who take Injectafer may suffer from serious, life-threatening allergic reactions, including: Low blood pressure, shock and loss of consciousness which may lead to death.

Skin problems, rash, hives and wheezing may also occur. Make sure you tell your provider about trouble breathing or skin rashes.

After receiving an infusion, providers monitor patients for at least 30 minutes to watch for signs of a reaction.

High Blood Pressure

Four percent of patients who received Injectafer during clinical trials reported high blood pressure sometimes accompanied with dizziness, facial flushing or nausea. This typically resolves within 30 minutes.

Medical providers will monitor patients for signs of high blood pressure after receiving Injectafer. Patients with high blood pressure should inform their health care provider before taking Injectafer.

Iron Overload

Receiving too much Injectafer may lead to iron overload. Iron overload occurs when there is too much iron in the body. This can increase the risk of diabetes, liver disease, osteoarthritis, hypothyroidism, osteoporosis, heart failure and/or heart attack.

Talk to your doctor if you experience symptoms such as: Gray or green skin color, a metallic taste in your mouth, blood in the stool, abdominal pain, hair loss, infertility, depression, chronic fatigue or joint pain.

Other Serious Side Effects

According to the drug’s prescribing information, other reported serious side effects include: Difficulty breathing, rash, rapid heartbeat, itching, chest discomfort, fever, chills, swelling of the face, lips, or tongue, muscle aches, back pain and fainting.

Hypophosphatemia is a condition where a person has abnormally low phosphate levels. In adult blood tests, this means a phosphate level of less than 2.5 mg/dl.

In February 2020, Injectafer’s manufacturer added a warning to the drug’s label for symptomatic hypophosphatemia. In some studies, researchers have found Injectafer is more likely to cause hypophosphatemia than other iron replacements.

Mild cases of hypophosphatemia don’t usually have symptoms.

Several patients have filed Injectafer lawsuits after suffering hypophosphatemia. Lawsuits claim drug manufacturers failed to properly warn the public about the risk.

Most Injectafer side effects are considered mild and usually go away within a few minutes after infusion. Like other drugs, some side effects may last for a few days to weeks.

Some people may have a spike in blood pressure accompanied by flushing, dizziness or nausea. This usually resolves in about 30 minutes, according to the drug’s prescribing information.

Long-lasting skin discoloration may occur if Injectafer spills out of the administration site and onto the skin.