"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
Acetadote Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Acetadote (acetylcysteine) Injection is an amino acid used to prevent or lessen hepatic injury due to acetaminophen overdose. It is available in generic form. Common side effects of Acetadote include rash, hives, and itching.
The recommended dose of Acetadote is 300 mg/kg administered over 21 hours. 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. Talk to your doctor about taking Acetadote if you are pregnant. Exercise caution if you are taking Acetadote while breastfeeding.
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.
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Acetadote Overview - Patient Information: Side Effects
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Acetadote (Acetylcysteine Injection)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Acetadote FDA Prescribing Information: Side Effects
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 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
|Number of Patients||n=109||n=71|
|Cardiac disorders||5 (5%)||2 (3%)|
|Tachycardia NOS||4 (4%)||1 (1%)||2 (3%)|
|Gastrointestinal disorders||16 (15%)||7 (10%)|
|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%)|
|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%)|
|Throat tightness||1 (1%)|
|Skin & subcutaneous tissue disorders||6 (6%)||5 (7%)|
|Pruritus||1 (1%)||2 (3%)|
|Rash NOS||3 (3%)||2 (2%)||3 (4%)|
|Vascular disorders||2 (2%)||3 (4%)|
|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
|Reaction||% of Patients (n=4709)|
Table 7: Distribution of reported reactions in
pediatric patients receiving intravenous acetylcysteine
|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.|
Read the entire FDA prescribing information for Acetadote (Acetylcysteine Injection)
Additional Acetadote Information
- Acetadote Drug Interactions Center: acetylcysteine iv
- Acetadote Side Effects Center
- Acetadote Overview including Precautions
- Acetadote FDA Approved Prescribing Information including Dosage
Acetadote - User Reviews
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.