A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Acetadote Side Effects, and Drug Interactions - Acetylcysteine
Acetadote Side Effects, and Drug Interactions - Acetylcysteine
SIDE EFFECTS
In the literature the most frequently reported adverse events attributed to I.V. acetylcysteine administration were rash, urticaria, and pruritus. The frequency of adverse events has been reported to be between 0.2% and 20.8%, and they most commonly occur during the initial loading dose of acetylcysteine.
The Incidence of drug-related adverse events occurring within the first 2 hours following acetylcysteine administration reported in a randomized study (Infusion Rate 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.
Treatment Group |
15-min |
60-min |
Number of Patients |
n=109 |
n-71 |
Cardiac disorders |
5(5%) |
2(3%) |
|
Severity:
|
Unknown |
Mild |
Moderate |
Severe |
Unknown |
Mild |
Moderate |
Severe |
Tachycardia NOS |
|
4(4%) |
1(1%) |
|
|
2(3%) |
|
|
Ear and labyrinth disorders |
1(1%) |
0(0%) |
|
Severity:
|
Unknown |
Mild |
Moderate |
Severe |
Unknown |
Mild |
Moderale |
Severe |
Ear pain |
|
|
1(1%) |
|
|
|
|
|
Gastrointestinal disorders |
16(15%) |
7(10%) |
|
Severity:
|
Unknown |
Mild |
Moderate |
Severe |
Unknown |
Mild |
Moderaw |
Severe |
|
Nausea
|
1(1%) |
|
6(6%) |
|
|
1(1%) |
1(1%) |
|
Vomiting NOS |
|
2(2%) |
11(10%) |
|
|
2(3%) |
4(6%) |
|
General disorders and administration site conditions |
1(1%) |
1(1%) |
|
Severity;
|
Unknown |
Mild |
Moderate |
Severe |
Unknown |
Mild |
Moderate |
Severe |
|
Chest tightness
|
|
1(1%) |
|
|
|
|
|
|
|
Feeling hot
|
|
|
|
|
|
1(1%) |
|
|
Immune system disorders |
20(18%) |
10(14%) |
|
Severity:
|
Unknown |
Mild |
Moderate |
Severe |
Unknown |
Mild |
Moderate |
Severe |
Anaphylactoid |
2(2%) |
6(6%) |
11(10%) |
1(1%) |
|
4(6%) |
5(7%) |
1(1%) |
Respiratory, thoracic and mediastinal disorders |
2(2%) |
2(3%) |
|
Severity:
|
Unknown |
Mild |
Moderate |
Severe |
Unknown |
Mild |
Moderate |
Severe |
Pharyngitis |
|
|
1(1%) |
|
|
|
|
|
Rhinorrhoea |
|
1(1%) |
|
|
|
|
|
|
Rhonchi |
|
|
|
|
|
1(1%) |
|
|
Throat tightness |
|
|
|
|
|
1(1%) |
|
|
Skin and subcutaneous tissue disorders |
6(6%) |
5(7%) |
|
Severity:
|
Unknown |
Mild |
Moderate |
Severe |
Unknown |
Mild |
Moderate |
Severe |
Pruritus |
|
1(1%) |
|
|
|
2(3%) |
|
|
Rash NOS |
|
3(3%) |
2(2%) |
|
|
3(4%) |
|
|
Vascular disorders |
2(2%) |
3(4%) |
|
Severity:
|
Unknown |
Mild |
Moderate |
Severn |
Unknown |
Mild |
Moderate |
Severe |
Flushing |
|
1(1%) |
1(1%) |
|
|
2(3%) |
1(1%) |
|
Adverse events summarized by the Rocky Mountain Poison and Drug Center from 76 published articles in which I.V. acetylcysteine was administered (acetaminophen overdose and other published uses) are listed with an incidence greater than 1% in Table 2. Charcoal, naloxone, and benzodiazepines were administered concomitantly in several of these studies.
|
Table 2 Adverse Events greater than 1% by Body System: Published Clinical Studies, Acetaminophen Overdose and Other : Published Uses
|
Body System Classification
|
Adverse Event Occurrences |
Distribution of All Adverse Events (%) |
% Frequency in Patients with Safety Monitoring (N = 2040)
|
Body as a Whole & Combinations
|
Urticaria
|
34
|
7.96
|
1.67
|
Vasodilatation and rash
|
30
|
7.03
|
1.47
|
Vasodilatatian, rash, and pruritus
|
42
|
9.84
|
2.06
|
Cardiovascular System
|
Hypotension
|
16
|
3.75
|
0.78
|
Syncope
|
13
|
3.04
|
0.64
|
Vasodilatation
|
28
|
6.56
|
1.37
|
Digestive System
|
|
|
|
Dyspepsia
|
5
|
1.17
|
0.24
|
Nausea
|
43
|
10.07
|
2.11
|
Vomiting
|
5 1
|
3.51
|
0.74
|
Nervous System
|
Abnormal thinking (Dysphoria)
|
3
|
1.87
|
0.39
|
Gait disturbances
|
5
|
1.17
|
0.24
|
Respiratory System
|
|
|
|
Bronchospasm
|
25
|
5.85
|
1.23
|
Coughing
|
S I
|
4.22
|
0.88
|
Dyspnea
|
11
|
2.58
|
0.54
|
Skin & Appendages
|
Angioedema
|
33
|
7.73
|
1.62
|
Facial erythema
|
5
|
1.17
|
0.24
|
Palmar erythema
|
6
|
1.41
|
0.29
|
Pruritus
|
5
|
1.17
|
0.24
|
Pruritus and rash
|
7
|
1.64
|
0.34
|
Rash
|
21
|
4.92
|
1.03
|
Sweating
|
6
|
1.41
|
0.29
|
Special Senses
|
Pain - Eve
|
11
|
2.58
|
0.54
|
Data on file: Systematic Analysis of Medical Literature Regarding Safety of I.V. N-acetylcysteine, Rocky Mountain Poison & Drug Center, Denver Health; 27 December 2001.
|
DRUG INTERACTIONS
Drug stability and safety of acetylcysteine when mixed with other drugs have not been established.
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