Applies to hetastarch: intravenous solution.

Serious side effects of Hetastarch

Along with its needed effects, hetastarch 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 hetastarch:

Incidence not known

• Bloody or cloudy urine
• blue lips and fingernails
• blurred vision
• chest pain, discomfort, or tightness
• confusion
• cough
• coughing that sometime produces a pink frothy sputum
• decreased urine output
• difficult or painful urination
• difficulty swallowing
• dilated neck veins
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• drowsiness
• fainting
• fast, slow, or irregular heartbeat or pulse
• fever
• hives, itching, skin rash
• increased sweating
• large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• muscle tremors
• nausea
• noisy breathing
• no blood pressure or pulse
• pale skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid shallow breathing
• restlessness
• sneezing
• stomach cramps
• stopping of the heart
• sudden increase or decrease in the amount of urine
• sweating
• swelling around the eyes
• swelling in the legs and ankles
• swelling of the face, fingers, feet, or lower legs
• unconsciousness
• unusual bleeding or bruising
• unusual tiredness or weakness
• weight gain

Other side effects of Hetastarch

Some side effects of hetastarch 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:

Incidence not known

• Chills
• diarrhea
• general feeling of discomfort or illness
• headache
• joint pain
• muscle aches and pains
• runny nose
• shivering
• sore throat
• tingling of the feet
• trouble sleeping
• unusual weight gain or loss
• vomiting

For Healthcare Professionals

Applies to hetastarch: intravenous solution.

Cardiovascular

Frequency not reported: Circulatory overload, congestive heart failure, pulmonary edema, peripheral edema of the lower extremities^[Ref]

Gastrointestinal

Frequency not reported: Vomiting^[Ref]

Hematologic

Frequency not reported: Intracranial bleeding, bleeding and/or anemia due to hemodilution and/or Factor VIII deficiency, acquired von Willebrand's-like syndrome, coagulopathy (including rare cases of disseminated intravascular coagulopathy and hemolysis)^[Ref]

Hypersensitivity

Frequency not reported: Death, life-threatening anaphylactic/anaphylactoid reactions, cardiac arrest, ventricular fibrillation, severe hypotension, non-cardiac pulmonary edema, laryngeal edema, bronchospasm, angioedema, wheezing, restlessness, tachypnea, stridor, fever, chest pain, bradycardia, tachycardia, shortness of breath, chills, urticaria, pruritus, facial and periorbital edema, coughing, sneezing, flushing erythema multiforme, rash^[Ref]

Metabolic

Frequency not reported: Metabolic acidosis^[Ref]

Musculoskeletal

Frequency not reported: Muscle pain^[Ref]

Other

Frequency not reported: Submaxillary and parotid glandular enlargement, mild influenza-like symptoms, headaches, hydroxyethyl starch-associated pruritus in patients with deposits of hydroxyethyl starch in peripheral nerves^[Ref]

Respiratory

Frequency not reported: Pulmonary edema^[Ref]

General

-The most common adverse reactions are hypersensitivity, coagulopathy, hemodilution, circulatory overload and metabolic acidosis.

-Serious adverse events reported in clinical trials are increased mortality and renal replacement therapy in critically ill patients.^[Ref]

Renal

Frequency not reported: Need for renal replacement therapy^[Ref]