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

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In the literature the most frequently reported adverse reactions attributed to I.V. acetylcysteine administration were rash, urticaria and pruritus. The frequency of adverse reactions has been reported to be between 0.2% and 20.8%, and they most commonly occur during the initial loading dose of acetylcysteine.

Loading Dose/Infusion Rate Study

The incidence of drug-related adverse reactions occurring within the first 2 hours following acetylcysteine administration reported in a randomized study in patients with acetaminophen poisoning is presented in Table 4 by preferred term. In this study patients were randomized to a 15-minute or a 60-minute loading dose regimen.

Within the first 2 hours following I.V. acetylcysteine administration, 17% developed an anaphylactoid reaction (18% in the 15-minute treatment group; 14% in the 60-minute treatment group) in this randomized, open-label, multi-center clinical study conducted in Australia to compare the rates of anaphylactoid reactions between two rates of infusion for the I.V. acetylcysteine loading dose [see Warnings (Section 5) and Clinical Studies - Loading Dose/Infusion Rate Study (Section 14)].

Table 4. Incidence of Drug-Related Adverse Reactions Occurring Within the First 2 Hours Following Study Drug Administration by Preferred Term: Loading Dose/Infusion Rate Study

Treatment Group	15-min				60-min
Number of Patients	n=109				n=71
Unkn=Unknown
Cardiac disorders	5 (5%)				2 (3%)
Severity:	Unkn	Mild	Moderate	Severe	Unkn	Mild	Moderate	Severe
Tachycardia NOS		4 (4%)	1 (1%)			2 (3%)
Gastrointestinal disorders	16 (15%)				7 (10%)
Severity:	Unkn	Mild	Moderate	Severe	Unkn	Mild	Moderate	Severe
Nausea	1 (1%)		6 (6%)			1 (1%)	1 (1%)
Vomiting NOS		2 (2%)	11 (10%)			2 (3%)	4 (6%)
Immune System Disorders	20 (18%)				10 (14%)
Severity:	Unkn	Mild	Moderate	Severe	Unkn	Mild	Moderate	Severe
Anaphylactoid reaction	2 (2%)	6 (6%)	11 (10%)	1 (1%)		4 (6%)	5 (7%)	1 (1%)
Respiratory, thoracic and mediastinal disorders	2 (2%)				2 (3%)
Severity:	Unkn	Mild	Moderate	Severe	Unkn	Mild	Moderate	Severe
Pharyngitis			1 (1%)
Rhinorrhoea		1 (1%)
Rhonchi						1 (1%)
Throat tightness						1 (1%)
Skin & subcutaneous tissue disorders	6 (6%)				5 (7%)
Severity:	Unkn	Mild	Moderate	Severe	Unkn	Mild	Moderate	Severe
Pruritus		1 (1%)				2 (3%)
Rash NOS		3 (3%)	2 (2%)			3 (4%)
Vascular disorders	2 (2%)				3 (4%)
Severity:	Unkn	Mild	Moderate	Severe	Unkn	Mild	Moderate	Severe
Flushing		1 (1%)	1 (1%)			2 (3%)	1 (1%)

 Postmarketing Safety Study

 A large multi-center study was performed in Canada where data were collected from patients who were treated with I.V. NAC for acetaminophen overdose between 1980 and 2005. This study evaluated 4709 adult cases and 1905 pediatric cases. The incidence of anaphylactoid reactions in adult (overall incidence 7.9%) and pediatric (overall incidence 9.5%) patients is presented in Tables 5 and 6.

Table 5. Distribution of reported reactions in adult patients receiving I.V. NAC

	Incidence (%)
Reaction	% of Patients (n=4709)
* Respiratory symptoms are defined as presence of any of the following: cough, wheezing, stridor, shortness of breath, chest tightness, respiratory distress, or bronchospasm.
Urticaria/Facial Flushing	6.1%
Pruritus	4.3%
Respiratory Symptoms*	1.9%
Edema	1.6%
Hypotension	0.1%
Anaphylaxis	0.1%

Table 6. Distribution of reported reactions in pediatric patients receiving I.V. NAC

	Incidence (%)
Reaction	% of Patients (n=1905)
* Respiratory symptoms are defined as presence of any of the following: cough, wheezing, stridor, shortness of breath, chest tightness, respiratory distress, or bronchospasm.
Urticaria/Facial Flushing	7.6%
Pruritus	4.1%
Respiratory Symptoms*	2.2%
Edema	1.2%
Anaphylaxis	0.2%
Hypotension	0.1%

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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.

Hematologic

Hematologic side effects have included increased blood loss and use of blood products when acetylcysteine was used to prevent perioperative inflammation and ischemia-reperfusion injury during cardiac surgery.

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