Acetadote Side Effects

Generic Name: acetylcysteine,acetylcysteine

Please note - some side effects for Acetadote may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Acetadote Side Effects - for the Professional

Acetadote

Most common adverse reactions (incidence >2%) are rash, urticaria/facial flushing and pruritus (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Cumberland Pharmaceuticals Inc. at 1-877-484-2700 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Side Effects by Body System

Gastrointestinal

Gastrointestinal side effects reported after oral administration have included nausea, vomiting, diarrhea, heartburn, dyspepsia, rectal bleeding, and epigastric pain. Stomatitis, hemoptysis, and rhinorrhea have been associated with the use of nebulized acetylcysteine.

Hypersensitivity

Allergic reactions to intravenous use have occurred. Symptoms have included urticarial rash, pruritus, flushing, a warm feeling of the skin, occasional bronchospasm or hypotension, angioedema, dyspnea, a serum sickness-like reaction, and asthma.

Respiratory

Respiratory side effects, including bronchospasm, wheezing, precipitation of asthma, and respiratory arrest, have been reported after respiratory or intravenous administration. Hemoptysis rarely occurs.

Nervous system

CNS side effects of dizziness, drowsiness, lightheadedness, and asthenia have occurred with oral use. Headache and increased intracranial pressure have been reported rarely.

Cardiovascular

One case of ST segment depression, chest pain, and T-wave inversion was associated with an anaphylactoid reaction to intravenous acetylcysteine.

Cardiovascular side effects of tachycardia and hypotension have been reported in patients with hypersensitivity to acetylcysteine.

Dermatologic

Skin rashes and pruritus have been reported. Skin reactions are a common presentation of hypersensitivity to intravenous administration.

Rashes seen after intravenous therapy usually consist of transient flushing on the upper trunk, neck and face. Rashes sometimes were urticarial and pruritic.

Local

Local reactions to injectable 20% acetylcysteine solution extravasation include severe pain and excoriation.

Other

Fever is a rarely occurring side effect seen after both inhalation and intravenous administration.

Musculoskeletal

Musculoskeletal side effects have rarely included myalgia and arthralgia.

Hepatic

Elevated serum transaminase levels were temporally associated with acetylcysteine administration in a patient with cystic fibrosis. At the dose used for acetaminophen toxicity, acetylcysteine does not have hepatotoxic effects.

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