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Acetadote (Acetylcysteine Injection) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Acetadote (Acetylcysteine Injection) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (6)

Reports by Reaction Type

Infusion Related Reaction (3)Transaminases Increased (2)LIP Swelling (1)Maternal Drugs Affecting Foetus (1)Headache (1)Haematocrit Decreased (1)Overdose (1)Haemolytic Uraemic Syndrome (1)Renal Failure Acute (1)Dyspnoea (1)Vomiting (1)Restlessness (1)

Possible Acetadote side effects in 56 year old female

Reported by a pharmacist from United States on 2012-03-05

Patient: 56 year old female, weighing 87.8 kg (193.2 pounds)

Reactions: Vomiting, Nausea, Restlessness, Headache, Feeling Abnormal, Infusion Related Reaction

Drug(s) suspected as cause:
Acetadote



Possible Acetadote side effects in 59 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-29

Patient: 59 year old female, weighing 83.5 kg (183.6 pounds)

Reactions: Medication Error

Drug(s) suspected as cause:
Acetadote

Other drugs received by patient: Vicodin; Tylenol



Possible Acetadote side effects 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

Drug(s) suspected as cause:
Acetadote

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



Possible Acetadote side effects in

Reported by a health professional (non-physician/pharmacist) from Hungary on 2012-01-06

Patient:

Reactions: Cleft LIP, Cleft Palate, Maternal Drugs Affecting Foetus, Maternal Exposure Timing Unspecified

Drug(s) suspected as cause:
Tegretol
    Indication: Epilepsy

Mesantoin
    Indication: Epilepsy

Valium
    Indication: Epilepsy

Dilantin
    Indication: Epilepsy

Acetadote
    Indication: Epilepsy



Possible Acetadote side effects 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

Drug(s) suspected as cause:
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 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

Drug(s) suspected as cause:
Acetadote

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