Applies to sodium ferric gluconate complex: intravenous solution.

Serious side effects

Along with its needed effects, sodium ferric gluconate complex may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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

More common

• 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, discomfort, heaviness, or tightness
• cold sweats
• confusion
• cool, pale skin
• cough or hoarseness
• coughing that sometimes produces a pink frothy sputum
• decreased level of consciousness
• decreased urine
• depression
• diarrhea
• difficult, burning, or painful urination
• 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, cramps, and pains
• 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
• seizures
• shakiness
• shivering
• slow or irregular heartbeat
• slurred speech
• sore throat
• stomach pain
• 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
• trouble breathing
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss
• weakness or heaviness of the legs
• weight gain

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, itching, skin rash
• increased menstrual flow or vaginal bleeding
• muscle stiffness, 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
• sweating
• tenderness

Other side effects

Some side effects of sodium ferric gluconate complex may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Accumulation of pus
• acid or sour stomach
• 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.

General

The most common adverse events were nausea, vomiting, diarrhea, injection site reaction, hypotension, cramps, hypertension, dizziness, abnormal erythrocytes (changes in morphology, color, or number of red blood cells), dyspnea, chest pain, leg cramps, pain, headache, and tachycardia.^[Ref]

Cardiovascular

Very common (10% or more): Hypotension (35%), hypertension (23%), tachycardia (17%)

Common (1% to 10%): Thrombosis

Frequency not reported: Bradycardia, vasodilatation, angina pectoris, myocardial infarction

Postmarketing reports: Hemorrhage, shock, phlebitis^[Ref]

Gastrointestinal

Very common (10% or more): Nausea/vomiting and/or diarrhea (35%)

Common (1% to 10%): Abdominal pain

Frequency not reported: Rectal disorder, dyspepsia, eructation, flatulence, gastrointestinal disorder, melena

Postmarketing reports: Dry mouth^[Ref]

Local

Very common (10% or more): Injection site reaction (33%)^[Ref]

Hypersensitivity

Postmarketing reports: Allergic reaction, anaphylactic-type reactions^[Ref]

Nervous system

Very common (10% or more): Headache (24%), dizziness (13%)

Common (1% to 10%): Headache, paresthesias, syncope

Frequency not reported: Lightheadedness, somnolence, decreased level of consciousness

Postmarketing reports: Hypertonia, loss of consciousness, convulsion, dysgeusia, hypoesthesia^[Ref]

Musculoskeletal

Very common (10% or more): Cramps (25%), leg cramps (10%)

Frequency not reported: Myalgia, arthralgia, back pain, arm pain^[Ref]

Respiratory

Very common (10% or more): Dyspnea (11%)

Common (1% to 10%): Coughing, upper respiratory infections, pharyngitis, rhinitis

Frequency not reported: Pneumonia, pulmonary edema^[Ref]

Dermatologic

Common (1% to 10%): Pruritus

Frequency not reported: Rash, increased sweating

Postmarketing reports: Skin discoloration^[Ref]

Hematologic

Very common (10% or more): Abnormal erythrocytes (changes in morphology, color, or number of red blood cells) (11%)

Frequency not reported: Anemia, leukocytosis, lymphadenopathy^[Ref]

Other

Very common (10% or more): Chest pain (10%), pain (10%)

Common (1% to 10%): Asthenia, fatigue, fever, malaise, infection, generalized edema

Frequency not reported: Infection, abscess, chills, rigors, flu-like syndrome, weakness, deafness, leg edema, peripheral edema, edema^[Ref]

Metabolic

Common (1% to 10%): Hyperkalemia

Frequency not reported: Anorexia, hypoglycemia, hypervolemia, hypokalemia^[Ref]

Immunologic

Common (1% to 10%): Infection

Frequency not reported: Sepsis^[Ref]

Genitourinary

Frequency not reported: Urinary tract infection, menorrhagia^[Ref]

Psychiatric

Frequency not reported: Agitation

Postmarketing reports: Nervousness^[Ref]

Oncologic

Frequency not reported: Carcinoma^[Ref]

Ocular

Frequency not reported: Conjunctivitis, rolling of the eyes, watery eyes, puffy eye lids, arcus senilis, diplopia^[Ref]