Ferrlecit Side Effects

Please note - some side effects for Ferrlecit may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Ferrlecit - for the Consumer

Ferrlecit

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ferrlecit:

General feeling of discomfort; lightheadedness; tiredness; weakness.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); nausea; pain, redness, or swelling at the injection site; severe pain in the chest, back, groin, or sides of the body; shortness of breath; vomiting; wheezing.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch .

Side Effects by Body System

Hypersensitivity

Hypersensitivity reactions, including rare cases of life-threatening reactions, have been reported in patients receiving injectable iron products. In a postmarketing safety study, hypersensitivity reactions were reported in 0.8% of the patients who received one dose of sodium ferric gluconate complex.

One case of a life-threatening hypersensitivity reaction (diaphoresis, nausea, vomiting, severe lower back pain, dyspnea, wheezing for 20 minutes) was observed out of 1,097 patients who received a single dose of sodium ferric gluconate complex in a postmarketing safety study. Eight other patients had reactions that, in the view of the investigator, precluded further administration of the drug. Six of these patients experienced symptoms such as pruritus, facial flushing, chills, dyspnea/chest pain, and rash; two experienced nausea and hypotension. Another two patients experienced allergic reactions not deemed to be indicative of drug intolerance (nausea/malaise and nausea/dizziness). Patients who had demonstrated prior sensitivity to iron dextran (6.6% in the study) had an increased risk of adverse reaction to sodium ferric gluconate complex. The incidences of both drug intolerance and suspected allergic events following the first dose of sodium ferric gluconate complex were 2.8% in patients with prior iron dextran sensitivity compared to 0.8% in patients without prior iron dextran sensitivity. The patient who experienced a life-threatening reaction to sodium ferric gluconate complex had a previous severe anaphylactic reaction to iron dextran. Concomitant ACE inhibitor use (28% in the study) also appeared to be a risk factor. The incidences of both drug intolerance and suspected allergic events following the first dose of sodium ferric gluconate complex were 1.6% in patients on concomitant ACE inhibitor therapy compared to 0.7% in patients not using an ACE inhibitor. One patient had facial flushing immediately upon exposure to sodium ferric gluconate complex, but it resolved rapidly and spontaneously without intervention other than drug withdrawal, and no hypotension developed. The patient with the life-threatening event was not on ACE inhibitor therapy.

In two multiple-dose clinical studies, no fatal hypersensitivity reactions occurred among the 126 patients who received sodium ferric gluconate complex. Hypersensitivity events resulting in premature study discontinuation occurred in three out of 88 (3.4%) treated patients in one study. None of the 38 patients in the other study experienced hypersensitivity reactions.

However, it should be noted that cramps, pain, nausea, rash, flushing, pruritus, and dyspnea are also common symptoms associated with chronic renal failure.

Cardiovascular

Hypotensive reactions are not related to hypersensitivity and have usually resolved within one or two hours. Volume expansion may be considered if hypotension is symptomatic. The incidence of hypotension following administration of injectable iron products may be related to the rate of administration and total dose administered.

Hypotensive events were observed in 22 out of 1,097 patients following administration of sodium ferric gluconate complex in a postmarketing safety study. Hypotension has also been reported in European case reports. Of 226 renal dialysis patients exposed to sodium ferric gluconate complex reported in the literature, three (1.3%) patients experienced hypotensive events, which were accompanied by flushing in two. Among 126 patients who received sodium ferric gluconate complex in two multiple-dose clinical studies, one patient experienced a transient decreased level of consciousness without hypotension. Another patient discontinued treatment prematurely because of dizziness, lightheadedness, diplopia, malaise, and weakness without hypotension that required a brief hospitalization for observation. The syndrome resolved spontaneously.

Cardiovascular side effects associated with intravenous administration of iron have primarily included hypotension characterized by lightheadedness, malaise, fatigue, weakness, or severe pain in the chest, back, flanks, or groin. Hypotension was reported in 2% of the patients in a single-dose postmarketing safety study and 29% of patients in two multiple-dose clinical studies. Hypertension and chest pain occurred in less than 1% of patients in the single-dose study, and 13% and 10% of patients, respectively, in the multiple-dose studies. Other cardiovascular side effects reported in the multiple-dose studies have included syncope (6%), tachycardia (5%), bradycardia, vasodilatation, angina pectoris, myocardial infarction, and pulmonary edema. Phlebitis and shock have been reported in postmarketing use.

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, and diarrhea. These events occurred in 2% of patients in a single-dose postmarketing safety study and 35% of patients in two multiple-dose clinical studies. Other gastrointestinal side effects reported in the multiple-dose studies have included abdominal pain (6%), anorexia, dyspepsia, eructation, flatulence, and melena. At least two patients reported dry mouth in the single-dose study. Dysgeusia has been reported in postmarketing use.

Local

Local side effects have included injection site reactions, reported in 33% of patients in two multiple-dose clinical studies. Other local effects have included abscess and arm pain.

General

General side effects reported in two multiple-dose clinical studies have included pain (10%), asthenia (7%), fatigue (6%), fever (5%), generalized edema (5%), peripheral edema, malaise, chills, infection, and flu-like syndrome.

Nervous system

Nervous system side effects reported in two multiple-dose clinical studies have included dizziness (13%), headache (7%), paresthesias (6%), agitation, and somnolence. Hypoesthesia, loss of consciousness, and convulsion have been reported in postmarketing use.

Respiratory

Respiratory side effects reported in two multiple-dose clinical studies have included dyspnea (11%), cough (6%), upper respiratory infections (6%), rhinitis, and pneumonia.

Musculoskeletal

Musculoskeletal side effects reported in two multiple-dose clinical studies have included leg cramps (10%), rigors, myalgia, arthralgia, and back pain.

Dermatologic

Dermatologic side effects reported in two multiple-dose clinical studies have included pruritus (6%), rash, and increased sweating. Skin discoloration and pallor have been reported in postmarketing use.

Hematologic

Hematologic side effects reported in two multiple-dose clinical studies have included abnormal erythrocytes (11%), anemia, leukocytosis, and lymphadenopathy.

Metabolic

Metabolic side effects reported in two multiple-dose clinical studies have included hyperkalemia (6%), hypoglycemia, hypervolemia, and hypokalemia.

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