Ferrlecit Side Effects

Generic Name: sodium ferric gluconate complex

Note: This page contains information about the side effects of sodium ferric gluconate complex. Some of the dosage forms included on this document may not apply to the brand name Ferrlecit.

Not all side effects for Ferrlecit may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to sodium ferric gluconate complex: intravenous solution

In addition to its needed effects, some unwanted effects may be caused by sodium ferric gluconate complex (the active ingredient contained in Ferrlecit). In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking sodium ferric gluconate complex, check with your doctor or nurse immediately:

More common
  • Abdominal or stomach pain
  • anxiety
  • arm, back, or jaw pain
  • bladder pain
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • bloody or cloudy urine
  • bloody, black, or tarry stools
  • blue lips and fingernails
  • blurred vision
  • chest pain or discomfort
  • chest tightness or heaviness
  • cold sweats
  • confusion
  • convulsions
  • cool, pale skin
  • cough or hoarseness
  • coughing that sometimes produces a pink frothy sputum
  • decreased level of consciousness
  • decreased urine
  • depression
  • diarrhea
  • difficult or labored breathing
  • difficult, burning, or painful urination
  • difficult, fast, or noisy breathing, sometimes with wheezing
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • dry mouth
  • eye pain
  • fainting
  • fast or slow heartbeat
  • fast, pounding, or irregular heartbeat or pulse
  • feeling of warmth or heat
  • fever or chills
  • flushing or redness of the skin, especially on the face and neck
  • frequent urge to urinate
  • general feeling of discomfort or illness
  • headache
  • increased hunger
  • increased sweating
  • increased thirst
  • irregular heartbeat
  • joint pain
  • leg cramps
  • lightheadedness
  • loss of appetite
  • lower back or side pain
  • mood changes
  • muscle aches and pains
  • muscle cramps
  • nausea or vomiting
  • nervousness
  • nightmares
  • numbness or tingling in the hands, feet, or lips
  • pain or discomfort in the arms, jaw, back, or neck
  • pale skin
  • pounding in the ears
  • rapid weight gain
  • rapid, shallow breathing
  • runny nose
  • shakiness
  • shivering
  • shortness of breath
  • slow or irregular heartbeat
  • slurred speech
  • sore throat
  • sweating
  • swelling in the legs and ankles
  • swollen, painful, or tender lymph glands in the neck, armpit, or groin
  • tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
  • trouble sleeping
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • weakness or heaviness of the legs
  • weight gain
  • wheezing
Incidence not known
  • Bleeding gums
  • bluish color
  • changes in skin color
  • cold, clammy skin
  • coughing up blood
  • excessive muscle tone
  • face is warm or hot to touch
  • fast, weak pulse
  • hives
  • increased menstrual flow or vaginal bleeding
  • itching
  • muscle stiffness
  • muscle tension or tightness
  • nosebleeds
  • paralysis
  • prolonged bleeding from cuts
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • red or black, tarry stools
  • red or dark brown urine
  • skin rash
  • sweating
  • tenderness

Some of the side effects that can occur with sodium ferric gluconate complex may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Accumulation of pus
  • acid or sour stomach
  • anxiety
  • belching
  • bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
  • body aches or pain
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • burning, dry, or itching eyes
  • cramps
  • deafness
  • difficulty with moving
  • discharge or excessive tearing
  • double vision
  • ear congestion
  • excess air or gas in the stomach or intestines
  • feeling unusually cold
  • full feeling
  • heartburn
  • hyperventilation
  • increased sweating
  • indigestion
  • irritability
  • longer or heavier menstrual periods
  • loss of appetite
  • loss of voice
  • passing of gas
  • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  • restlessness
  • rolling of the eyes
  • seeing double
  • shivering
  • sleepiness or unusual drowsiness
  • sneezing
  • stomach discomfort or upset
  • swollen, red, or tender area of infection
  • voice changes
  • watery eyes
  • weight loss
Incidence not known
  • Change in taste
  • loss of taste

For Healthcare Professionals

Applies to sodium ferric gluconate complex: intravenous solution

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 (the active ingredient contained in Ferrlecit) [Ref]

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.[Ref]

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 (the active ingredient contained in Ferrlecit) 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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

Respiratory

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

Musculoskeletal

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

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.[Ref]

Hematologic

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

Metabolic

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

References

1. "Product Information. Ferrlecit (sodium ferric gluconate complex)." Schein Pharmaceuticals Inc, Florham Park, NJ.

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