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Aralast Side Effects

Generic Name: alpha 1-proteinase inhibitor

Note: This document contains side effect information about alpha 1-proteinase inhibitor. Some of the dosage forms listed on this page may not apply to the brand name Aralast.

For the Consumer

Applies to alpha 1-proteinase inhibitor: intravenous powder for solution, intravenous solution

Along with its needed effects, alpha 1-proteinase inhibitor (the active ingredient contained in Aralast) 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 alpha 1-proteinase inhibitor:

More common
  • Bladder pain
  • bloody or cloudy urine
  • body aches or pain
  • chills
  • cough
  • difficult, burning, or painful urination
  • difficulty with breathing
  • ear congestion
  • fever
  • frequent urge to urinate
  • headache
  • loss of voice
  • lower back or side pain
  • nasal congestion
  • runny nose
  • sneezing
  • sore throat
  • unusual tiredness or weakness
  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • blurred vision
  • chest pain
  • cough producing mucus
  • diarrhea
  • difficult or labored breathing
  • dizziness
  • feeling faint, dizzy, or lightheadedness
  • flushing or redness of the skin, especially on the face and neck
  • general feeling of discomfort or illness
  • joint pain
  • loss of appetite
  • muscle aches and pains
  • nausea
  • nervousness
  • noisy breathing
  • pounding in the ears
  • rapid weight gain
  • shivering
  • slow or fast heartbeat
  • sweating
  • tightness in the chest
  • tingling of the hands or feet
  • trouble sleeping
  • unusual weight gain or loss
  • vomiting
Incidence not known
  • Confusion
  • difficulty with swallowing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fast, pounding, or irregular heartbeat or pulse
  • hives
  • itching, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • skin rash

Some side effects of alpha 1-proteinase inhibitor 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
  • Feeling of warmth
  • itching skin
  • muscle or bone pain
  • pain or tenderness around the eyes and cheekbones
  • redness of the face, neck, arms, and occasionally, upper chest
  • sudden sweating
  • Back pain
  • bloating
  • change in taste
  • changes in vision
  • fever
  • hives or welts
  • loss of taste
  • pain
  • redness of the skin
  • sleepiness or unusual drowsiness
  • swelling of the joints
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

For Healthcare Professionals

Applies to alpha 1-proteinase inhibitor: intravenous powder for injection, intravenous solution


Respiratory side effects have included chest pain, pharyngitis, asthma, rhinitis, bronchitis, sinusitis, increased cough, upper and lower respiratory tract infections, dyspnea, chronic obstructive pulmonary disease (COPD) exacerbation, nasopharyngitis, pharyngolaryngeal pain, COPD, sore throat, bronchospasm, lung disorder, infective exacerbation of COPD, bilateral pulmonary infiltrates, and diffuse interstitial lung disease. Dyspnea has been reported during postmarketing experience.[Ref]

Nervous system

Nervous system side effects have included dizziness, headache, somnolence, dysgeusia, lethargy, lightheadedness, paresthesia, and migraine.[Ref]


Other side effects have included pain, back pain, viral infection, peripheral edema, chills, fever, chest pain, chest discomfort, influenza-like illness, pyrexia, delayed fever, influenza-like symptoms, allergic-like reactions, malaise, hot flush, asthenia, infection, and accidental injury. Chest pain, chills, and influenza-like illness have been reported during postmarketing experience.


Cardiovascular side effects have included vasodilation, hypertension, tachycardia, hypotension, and transient increase in blood pressure. Tachycardia, hypotension, and hypertension (including transient increases of blood pressure) have been reported during postmarketing experience.[Ref]


Hematologic side effects have included decreased platelet count, transient leukocytosis, dilutional anemia, ecchymosis, and hemorrhage.


Dermatologic side effects have included pruritus, rash, erythema marginatum, and urticaria. Rash has been reported during postmarketing experience.[Ref]


Gastrointestinal side effects have included bloating, nausea, abdominal pain, diarrhea, and dyspepsia.


Hepatic side effects have included elevations (greater than 2 times the upper limit of normal) in aminotransferases (ALT or AST), increased hepatic enzyme (unspecified), and cholangitis.[Ref]


Musculoskeletal side effects have included musculoskeletal discomfort, joint swelling, arthralgia, and myalgia.


Ocular side effects have included abnormal vision.[Ref]


Local side effects have included injection site pain, injection site hemorrhage, and injection site reaction.


Genitourinary side effects have included urinary tract infection.


Hypersensitivity side effects have included hypersensitivity during postmarketing experience.


1. "Product Information. Aralast (alpha 1-proteinase inhibitor)." Baxter I.V. Systems Division, Round Lake, IL.

Some side effects of Aralast may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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