DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Atracurium (Atracurium Besylate) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Observed in Controlled Clinical Studies: Atracurium was well tolerated and produced few adverse reactions during extensive clinical trials. Most adverse reactions were suggestive of histamine release. In studies including 875 patients, atracurium was discontinued in only one patient (who required treatment for bronchial secretions) and six other patients required treatment for adverse reactions attributable to atracurium (wheezing in one, hypotension in five). Of the five patients who required treatment for hypotension, three had a history of significant cardiovascular disease. The overall incidence rate for clinically important adverse reactions, therefore, was 7/875 or 0.8%.

Table 1 includes all adverse reaction reported attributable to atracurium during clinical trials with 875 patients.

TABLE 1: PERCENT OF PATIENTS REPORTING ADVERSE REACTIONS

Adverse Reaction

Initial Atracurium Dose (mg/kg)

0.00-0.30
(n=485)

0.31-0.50*
(n=366)

≥0.60
(n=24)

Total
(n=875)

Skin Flush

1.0%

8.7%

29.2%

5.0%

Erythema

0.6%

0.5%

0%

0.6%

Itching

0.4%

0%

0%

0.2%

Wheezing/Bronchial Secretions

0.2%

0.3%

0%

0.2%

Hives

0.2%

0%

0%

0.1%

*Includes the recommended initial dosage range for most patients.

Most adverse reactions were of little clinical significance unless they were associated with significant hemodynamic changes. Table 2 summarizes the incidences of substantial vital sign changes noted during atracurium clinical trials with 530 patients, without cardiovascular disease, in whom these parameters were assessed.

TABLE 2: PERCENT OF PATIENTS SHOWING >30% VITAL SIGN CHANGES FOLLOWING ADMINISTRATION OF ATRACURIUM

Vital Sign Change

Initial Atracurium Dose (mg/kg)

0.00-0.30
(n=365)

0.31-0.50*
(n=144)

≥0.60
(n=21)

Total
(n=530)

Mean Arterial Pressure 

  Increase

1.9%

2.8%

0%

2.1%

  Decrease

1.1%

2.1%

14.3%

1.9%

Heart Rate

  Increase

1.6%

2.8%

4.8%

2.1%

  Decrease

0.8%

0%

0%

0.6%

*Includes the recommended initial dosage range for most patients.

Observed in Clinical Practice: Based on initial clinical practice experience in approximately 3 million patients who received atracurium in the U.S. and in the United Kingdom, spontaneously reported adverse reactions were uncommon (approximately 0.01% to 0.02%). The following adverse reactions are among the most frequently reported, but there are insufficient data to support an estimate of their incidence:

General: Allergic reactions (anaphylactic or anaphylactoid responses) which, in rare instances, were severe (e.g., cardiac arrest)

Musculoskeletal: Inadequate block, prolonged block

Cardiovascular: Hypotension, vasodilatation (flushing), tachycardia, bradycardia

Respiratory: Dyspnea, bronchospasm, laryngospasm

Integumentary: Rash, urticaria, reaction at injection site

There have been rare spontaneous reports of seizures in ICU patients following long-term infusion of atracurium to support mechanical ventilation. There are insufficient data to define the contribution, if any, of atracurium and/or its metabolite laudanosine. (See PRECAUTIONS: Long-Term Use in Intensive Care Unit [ICU] ).

There have been post-marketing reports of severe allergic reactions (anaphylactic and anaphylactoid reactions) associated with use of neuromuscular blocking agents, including atracurium besylate. These reactions, in some cases, have been life-threatening and fatal. Because these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency (see  WARNINGS   and PRECAUTIONS ). 



REPORTS OF SUSPECTED ATRACURIUM SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Atracurium side effects / adverse reactions in 65 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-11-07

Patient: 65 year old female

Reactions: Wheezing, Anaphylactic Shock, Cardiac Output Decreased, Skin Reaction, Pulseless Electrical Activity, Oxygen Saturation Decreased

Adverse event resulted in: life threatening event

Suspect drug(s):
Atracurium
    Dosage: 40 mg, unk
    Indication: Induction of Anaesthesia
    Start date: 2011-10-20
    End date: 2011-10-20

Ondansetron HCL
    Dosage: 4 mg, unk
    Indication: Induction of Anaesthesia
    Start date: 2011-10-20
    End date: 2011-10-20

Fentanyl
    Dosage: 100 ug, unk
    Indication: Induction of Anaesthesia
    Start date: 2011-10-20
    End date: 2011-10-20

Propofol
    Dosage: 200 mg, unk
    Indication: Induction of Anaesthesia
    Start date: 2011-10-20
    End date: 2011-10-20

Other drugs received by patient: Citalopram; Simvastatin



Possible Atracurium side effects / adverse reactions in 28 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-02-03

Patient: 28 year old female weighing 95.0 kg (209.0 pounds)

Reactions: Pain, Liver Function Test Abnormal

Adverse event resulted in: hospitalization

Suspect drug(s):
Remifentanyl
    Indication: General Anaesthesia

Atracurium
    Indication: General Anaesthesia

Suprane
    Indication: General Anaesthesia
    Start date: 2011-10-11

Fentanyl Citrate
    Indication: General Anaesthesia

Ondansetron
    Indication: General Anaesthesia

Meperidine HCL
    Indication: General Anaesthesia
    Start date: 2011-10-10
    End date: 2011-10-10

Scopolamine
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-10-10
    End date: 2011-10-10

Cyclizine
    Indication: General Anaesthesia

Suprane
    Indication: Choledocholithotomy
    Start date: 2011-10-11

Dexamethasone
    Indication: General Anaesthesia



Possible Atracurium side effects / adverse reactions in 28 year old female

Reported by a physician from United Kingdom on 2012-02-21

Patient: 28 year old female weighing 95.0 kg (209.0 pounds)

Reactions: Liver Function Test Abnormal, Pain

Adverse event resulted in: hospitalization

Suspect drug(s):
Meperidine HCL
    Dosage: unk
    Indication: General Anaesthesia
    Start date: 2011-10-10
    End date: 2011-10-10

Dexamethasone
    Indication: General Anaesthesia

Suprane
    Dosage: 1 df, single
    Indication: General Anaesthesia
    Start date: 2011-10-10

Scopolamine
    Dosage: unk
    Start date: 2011-10-10
    End date: 2011-10-10

Suprane
    Indication: Choledocholithotomy

Ondansetron
    Indication: General Anaesthesia

Cyclizine
    Indication: General Anaesthesia

Fentanyl
    Indication: General Anaesthesia

Remifentanil
    Indication: General Anaesthesia

Atracurium
    Indication: General Anaesthesia



See index of all Atracurium side effect reports >>

Drug label data at the top of this Page last updated: 2012-10-22

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017