Acetadote Side Effects Center

Last updated on RxList: 5/26/2022
Acetadote Side Effects Center

What Is Acetadote?

Acetadote (acetylcysteine) Injection is an amino acid used to prevent or lessen hepatic injury due to acetaminophen overdose. Acetadote is available in generic form.

What Are Side Effects of Acetadote?

Common side effects of Acetadote include:

  • rash,
  • hives,
  • facial flushing (warmth, redness, or tingly feeling), itching, respiratory symptoms (cough, wheezing, noisy breathing, shortness of breath, chest tightness, or bronchospasm),
  • swelling, or low blood pressure (hypotension)

Dosage for Acetadote

The recommended dose of Acetadote is 300 mg/kg administered over 21 hours.

What Drugs, Substances, or Supplements Interact with Acetadote?

Other drugs may interact with Acetadote. Tell your doctor all medications you take. Before taking Acetadote tell your doctor if you have asthma or a history of bronchospasm.

Acetadote During Pregnancy and Breastfeeding

Talk to your doctor about taking Acetadote if you are pregnant. Exercise caution if you are taking Acetadote while breastfeeding.

Additional Information

Our Acetadote (acetylcysteine) Injection 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.


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Acetadote Professional Information

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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 intravenous acetylcysteine administration were rash, urticaria and pruritus. The frequency of adverse reactions has been reported to be between 0.2% and 21%, and they most commonly occur during the initial loading dose of acetylcysteine.

Loading Dose/Infusion Rate Study

In a randomized, open-label, multi-center clinical study conducted in Australia in patients with acetaminophen poisoning, the rates of hypersensitivity reactions between a 15-minute and 60-minute intravenous infusion for the 150 mg/kg loading dose of acetylcysteine were compared.

The incidence of drug-related adverse reactions occurring within the first 2 hours following acetylcysteine administration is presented in Table 5. Overall, 17% of patients developed an acute hypersensitivity reaction (18% in the 15-minute infusion group; 14% in the 60-minute infusion group) [see WARNINGS AND PRECAUTIONS, Clinical Studies].

Table 5. 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-minutes 60-minutes
Number of Patients n=109 n=71
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
Hypersensitivity 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%)
Rhinorrhea 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%)
Unkn= Unknown; NOS= not otherwise specified

Safety Study

A large multi-center study was performed in Canada where data were collected from patients who were treated with intravenous acetylcysteine for acetaminophen overdose between 1980 and 2005. This study evaluated 4709 adult cases and 1905 pediatric cases. The incidence of hypersensitivity reactions in adult (overall incidence 8%) and pediatric (overall incidence 10%) patients is presented in Tables 6 and 7.

Table 6. Distribution of reported hypersensitivity reactions in adult patients receiving intravenous acetylcysteine

Reaction Incidence (%) n=4709
Urticaria/Facial 6.1%
Pruritus 4.3%
Respiratory Symptoms* 1.9%
Edema 1.6%
Hypotension 0.1%
Anaphylaxis 0.1%

Table 7. Distribution of reported hypersensitivity reactions in pediatric patients receiving intravenous acetylcysteine

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


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Read the entire FDA prescribing information for Acetadote (Acetylcysteine Injection)


Digestive Disorders: Common Misconceptions See Slideshow

© Acetadote Patient Information is supplied by Cerner Multum, Inc. and Acetadote Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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