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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