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.

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:

Cramps; diarrhea; leg cramps; loss of appetite; nausea; stomach pain; tiredness; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur when using Ferrlecit:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); burning, numbness, or tingling; calf or leg pain, redness, tenderness, or swelling; chest pain; coughing; dizziness or light-headedness; fainting; fast, slow, or irregular heartbeat; fever or chills; flushing; increased sweating; muscle weakness; pain, redness, or swelling at the injection site; severe or persistent nausea, vomiting, or headache; severe pain in the chest, back, groin, or sides of the body; shortness of breath or other breathing problems; swelling; 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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Ferrlecit Side Effects - for the Professional

Ferrlecit

Exposure to Ferrlecit has been documented in over 1,400 patients on hemodialysis. This population included in 1,097 Ferrlecit-naïve patients who received a single-dose of Ferrlecit in a placebo-controlled, cross-over, post-marketing safety study. Undiluted Ferrlecit was administered over ten minutes (125 mg of Ferrlecit at 12.5 mg/min). No test dose was used. From a total of 1,498 Ferrlecit-treated patients in medical reports, North American trials, and post-marketing studies, twelve patients (0.8%) experienced serious reactions which precluded further therapy with Ferrlecit.

Hypersensitivity Reactions: See PRECAUTIONS. In the single-dose, post-marketing, safety study one patient experienced a life-threatening hypersensitivity reaction (diaphoresis, nausea, vomiting, severe lower back pain, dyspnea, and wheezing for 20 minutes) following Ferrlecit administration. Among 1,097 patients who received Ferrlecit in this study, there were 9 patients (0.8%) who had an adverse reaction that, in the view of the investigator, precluded further Ferrlecit administration (drug intolerance). These included one life-threatening reaction, six allergic reactions (pruritus x2, facial flushing, chills, dyspnea/chest pain, and rash), and two other reactions (hypotension and nausea). Another 2 patients experienced (0.2%) allergic reactions not deemed to represent drug intolerance (nausea/malaise and nausea/dizziness) following Ferrlecit administration.

Seventy-two (7.0%) of the 1,034 patients who had prior iron dextran exposure had a sensitivity to at least one form of iron dextran (INFeD® or Dexferrum®). The patient who experienced a life-threatening adverse event following Ferrlecit administration during the study had a previous severe anaphylactic reaction to dextran in both forms (INFeD® and Dexferrum®). The incidences of both drug intolerance and suspected allergic events following first dose Ferrlecit administration were 2.8% in patients with prior iron dextran sensitivity compared to 0.8% in patients without prior iron dextran sensitivity.

In this study, 28% of the patients received concomitant angiotensin converting enzyme inhibitor (ACEi) therapy. The incidences of both drug intolerance or suspected allergic events following first dose Ferrlecit administration were 1.6% in patients with concomitant ACEi use compared to 0.7% in patients without concomitant ACEi use. The patient with a life-threatening event was not on ACEi therapy. One patient had facial flushing immediately on Ferrlecit exposure. No hypotension occurred and the event resolved rapidly and spontaneously without intervention other than drug withdrawal.

In multiple dose Studies A and B, no fatal hypersensitivity reactions occurred among the 126 patients who received Ferrlecit. Ferrlecit-associated hypersensitivity events in Study A resulting in premature study discontinuation occurred in three out of a total 88 (3.4%) Ferrlecit-treated patients. The first patient withdrew after the development of pruritus and chest pain following the test dose of Ferrlecit. The second patient, in the high-dose group, experienced nausea, abdominal and flank pain, fatigue and rash following the first dose of Ferrlecit. The third patient, in the low-dose group, experienced a "red blotchy rash" following the first dose of Ferrlecit. Of the 38 patients exposed to Ferrlecit in Study B, none reported hypersensitivity reactions.

Many chronic renal failure patients experience cramps, pain, nausea, rash, flushing, and pruritus.

In the postmarketing spontaneous reporting system, lifethreatening hypersensitivity reactions have been reported rarely in patients receiving Ferrlecit.

Hypotension: See PRECAUTIONS. In the single dose safety study, post-administration hypotensive events were observed in 22/1,097 patients (2%) following Ferrlecit administration. Hypotension has also been reported following administration of Ferrlecit in European case reports. Of the 226 renal dialysis patients exposed to Ferrlecit and reported in the literature, 3 (1.3%) patients experienced hypotensive events, which were accompanied by flushing in two. All completely reversed after one hour without sequelae. Transient hypotension may occur during dialysis. Administration of Ferrlecit may augment hypotension caused by dialysis.

Among the 126 patients who received Ferrlecit in Studies A and B, 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 resulted in a 3–4 hour hospitalization for observation following drug administration. The syndrome resolved spontaneously.

Adverse Laboratory Changes: No differences in laboratory findings associated with Ferrlecit (sodium ferric gluconate complex in sucrose injection) were reported in North American clinical trials when normalized against a National Institute of Health database on laboratory findings in 1,100 hemodialysis patients.

Most Frequent Adverse Reactions: In the single-dose, postmarketing safety study, 11% of patients who received Ferrlecit and 9.4% of patients who received placebo reported adverse reactions. The most frequent adverse reactions following Ferrlecit were: hypotension (2%), nausea, vomiting and/or diarrhea (2%), pain (0.7%), hypertension (0.6%), allergic reaction (0.5%), chest pain (0.5%), pruritus (0.5%), and back pain (0.4%). Similar adverse reactions were seen following placebo administration. However, because of the high baseline incidence of adverse events in the hemodialysis patient population, insufficient number of exposed patients, and limitations inherent to the cross-over, single dose study design, no comparison of event rates between Ferrlecit and placebo treatments can be made.

In multiple-dose Studies A and B, the most frequent adverse reactions following Ferrlecit were:

Body as a Whole: injection site reaction (33%), chest pain (10%), pain (10%), asthenia (7%), headache (7%), abdominal pain (6%), fatigue (6%), fever (5%), malaise, infection, abscess, back pain, chills, rigors, arm pain, carcinoma, flu-like syndrome, sepsis.

Nervous System: cramps (25%), dizziness (13%), paresthesias (6%), agitation, somnolence.

Respiratory System: dyspnea (11%), coughing (6%), upper respiratory infections (6%), rhinitis, pneumonia.

Cardiovascular System: hypotension (29%), hypertension (13%), syncope (6%), tachycardia (5%), bradycardia, vasodilatation, angina pectoris, myocardial infarction, pulmonary edema.

Gastrointestinal System: nausea, vomiting and/or diarrhea (35%), anorexia, rectal disorder, dyspepsia, eructation, flatulence, gastrointestinal disorder, melena.

Musculoskeletal System: leg cramps (10%), myalgia, arthralgia.

Skin and Appendages: pruritus (6%), rash, increased sweating.

Genitourinary System: urinary tract infection.

Special Senses: conjunctivitis, abnormal vision, ear disorder.

Metabolic and Nutritional Disorders: hyperkalemia (6%), generalized edema (5%), leg edema, peripheral edema, hypoglycemia, edema, hypervolemia, hypokalemia.

Hematologic System: abnormal erythrocytes (11%), anemia, leukocytosis, lymphadenopathy.

Other Adverse Reactions Observed During Clinical Trials: In the single-dose post-marketing safety study in 1,097 patients receiving Ferrlecit, the following additional events were reported in two or more patients: hypertonia, nervousness, dry mouth, and hemorrhage.

Pediatric Patients: In a clinical trial of 66 iron-deficient pediatric hemodialysis patients, 6 to 15 years of age, inclusive, who were receiving a stable erythropoietin dosing regimen, the most common adverse events, whether or not related to study drug, occurring in ≥5%, regardless of treatment group, were: hypotension (35%), headache (24%), hypertension (23%), tachycardia (17%), vomiting (11%), fever (9%), nausea (9%), abdominal pain (9%), pharyngitis (9%), diarrhea (8%), infection (8%), rhinitis (6%), and thrombosis (6%). More patients in the higher dose group (3.0 mg/kg) than in the lower dose group (1.5 mg/kg) experienced the following adverse events: hypotension (41% vs. 28%), tachycardia (21% vs. 13%), fever (15% vs. 3%), headache (29% vs. 19%), abdominal pain (15% vs. 3%), nausea (12% vs. 6%), vomiting (12% vs. 9%), pharyngitis (12% vs. 6%), and rhinitis (9% vs. 3%).

Postmarketing Surveillance: The following additional adverse reactions have been identified with the use of Ferrlecit from postmarketing spontaneous reports:  dysgeusia, hypoesthesia, loss of consciousness, convulsion, skin discoloration, pallor, phlebitis, and shock. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

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Side Effects by Body System - for Healthcare Professionals

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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