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Acetadote (Acetylcysteine Injection) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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 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 5 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 intravenous 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 intravenous acetylcysteine loading dose [see Warnings (Section 5) and Clinical Studies - Loading Dose/Infusion Rate Study (Section 14)].

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

Unkn=Unknown

Treatment Group 15-min 60-min
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
        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 intravenous acetylcysteine 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 6 and 7.

Table 6. Distribution of reported reactions in adult patients receiving intravenous acetylcysteine
Incidence (%)
Reaction % of Patients (n=4709)
Urticaria/Facial Flushing 6.1%
Pruritus 4.3%
Respiratory Symptoms* 1.9%
Edema 1.6%
Hypotension 0.1%
Anaphylaxis 0.1%
Table 7. Distribution of reported reactions in pediatric patients receiving intravenous acetylcysteine

*Respiratory symptoms are defined as presence of any of the following: cough, wheezing, stridor, shortness of breath, chest tightness, respiratory distress, or bronchospasm.

Incidence (%)
Reaction % of Patients (n=1905)
Urticaria/Facial Flushing 7.6%
Pruritus 4.1%
Respiratory Symptoms* 2.2%
Edema 1.2%
Anaphylaxis 0.2%
Hypotension 0.1%



REPORTS OF SUSPECTED ACETADOTE SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Acetadote. The information is not vetted and should not be considered as verified clinical evidence.

Possible Acetadote side effects / adverse reactions in 56 year old male

Reported by a pharmacist from United States on 2011-10-05

Patient: 56 year old male weighing 82.0 kg (180.4 pounds)

Reactions: LIP Swelling, Rash Erythematous, Rash Maculo-Papular, Infusion Related Reaction

Suspect drug(s):
Acetadote



Possible Acetadote side effects / adverse reactions in 21 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-02

Patient: 21 year old female weighing 70.0 kg (154.0 pounds)

Reactions: Dyspnoea, Hypotension, Incorrect Dose Administered, Transaminases Increased, Haemodialysis, Haemoglobin Decreased, Haematocrit Decreased, Overdose, Haemolytic Uraemic Syndrome, Renal Failure Acute, Infusion Related Reaction

Adverse event resulted in: hospitalization

Suspect drug(s):
Acetadote
    Dosage: 17.5g/500ml over 4hrs iv

Acetadote
    Dosage: 52.5g/500ml over 1hr iv

Other drugs received by patient: Montelukast Sodium; Sertraline Hydrochloride; Venlafaxine



Possible Acetadote side effects / adverse reactions in 12 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-16

Patient: 12 year old female weighing 64.0 kg (140.8 pounds)

Reactions: International Normalised Ratio Increased, Encephalopathy, Transaminases Increased

Adverse event resulted in: hospitalization

Suspect drug(s):
Acetadote

Other drugs received by patient: Citalopram Hydrobromide; Dextroamphetamine; Risperidone; Diphenhydramine HCL



See index of all Acetadote side effect reports >>

Drug label data at the top of this Page last updated: 2013-06-05

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