"The U.S. Food and Drug Administration today approved Opsumit (macitentan), a new drug to treat adults with pulmonary arterial hypertension (PAH), a chronic, progressive and debilitating disease that can lead to death or the need for lung transpla"...
- Clinician Information:
Acetylcysteine Solution Side Effects Center
Medical Editor: Charles Patrick Davis, MD, PhD
Acetylcysteine solution, USP (n-acetyl-l-cysteine) is a solution of a naturally occurring amino acid that is used to help clear mucus (acts as a mucolytic agent) and material entrapped in mucus in people that have thick mucus that may interfere with breathing or other functions. For example, it may be used to help clear mucus in COPD, cystic fibrosis, pneumonia, and in tracheostomy care. Acetylcysteine solution The drug may also be used as an antidote for acetaminophen toxicity. The drug is available as a generic. Common side effects of Acetylcysteine solution include stomatitis, nausea, vomiting, fever, runny nose (rhinorrhea), and drowsiness.
Acetylcysteine solution, USP (n-acetyl-l-cysteine) is supplied as a sterile unpreserved solution (not for injection) in vials containing a 10% (100 mg/mL) or 20% (200 mg/mL) solution of acetylcysteine. When nebulized into a face mask, mouthpiece, or tracheostomy, 1 to 10 mL of the 20% solution or 2 to 20 mL of the 10% solution may be given every 2 to 6 hours; the recommended dose for most patients is 3 to 5 mL of the 20% solution or 6 to 10 mL of the 10% solution three to four times a day. Other dosing depends on the treatment planned by the doctor. Administration of acetylcysteine solution this drug for acetaminophen toxicity is an emergency and should be given within the first 24 hours of acetaminophen ingestion; only physicians should guide administration of the drug. Methods and doses are complex and are available in tabular form in the Side Effects Drug Center and in other publications; acetylcysteine solution is not approved for IV administration. Serious side effects of acetylcysteine solution may include chest tightness, bronchoconstriction and bleeding. Thinning mucus may need to be suctioned. There are no adequate and well-controlled studies of acetylcysteine solution in pregnant women; it is not known if acetylcysteine solution is excreted in breast milk. Acetylcysteine has been used in special instances in pediatric patients.
Our Acetylcysteine solution, USP (n-acetyl-l-cysteine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Acetylcysteine Solution FDA Prescribing Information: Side Effects
ACETYLCYSTEINE AS A MUCOLYTIC AGENT
Adverse effects have included stomatitis, nausea, vomiting, fever, rhinorrhea, drowsiness, clamminess, chest tightness and bronchoconstriction. Clinically overt acetylcysteine induced bronchospasm occurs infrequently and unpredictably even in patients with asthmatic bronchitis or bronchitis complicating bronchial asthma.
Acquired sensitization to acetylcysteine has been reported rarely. Reports of sensitization in patients have not been confirmed by patch testing. Sensitization has been confirmed in several inhalation therapists who reported a history of dermal eruptions after frequent and extended exposure to acetylcysteine.
Reports of irritation to the tracheal and bronchial tracts have been received and although hemoptysis has occurred in patients receiving acetylcysteine such findings are not uncommon in patients with bronchopulmonary disease and a causal relationship has not been established.
ACETYLCYSTEINE AS AN ANTIDOTE FOR ACETAMINOPHEN OVERDOSAGE
Oral administration of acetylcysteine, especially in the large doses needed to treat acetaminophen overdose, may result in nausea, vomiting and other gastrointestinal symptoms. Rash with or without mild fever has been observed rarely.
Read the entire FDA prescribing information for Acetylcysteine Solution (N-acetyl-L-cysteine) »
Additional Acetylcysteine Solution Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.