This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Neostigmine 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 (14)
Death (6)
Life Threatening Events (2)
Reports by Reaction Type
Acute Respiratory Distress Syndrome (5),
Acute Respiratory Failure (5),
Chylothorax (3),
Sepsis (3),
Drug Interaction (2),
Erythema (2),
Pulmonary Granuloma (2),
Hypoxia (2),
Pulmonary Oedema (2),
Atrioventricular Dissociation (2),
Dysarthria (2),
Electrocardiogram ST Segment Elevation (2)
Possible Neostigmine side effects in 21 year old female
Reported by a health professional (non-physician/pharmacist) from Austria on 2012-04-27
Patient: 21 year old female, weighing 65.0 kg (143.0 pounds)
Reactions: Drug Interaction, Atrioventricular Dissociation
Drug(s) suspected as cause:
Midazolam
Dosage: 7.5 mg
Administration route: Oral
Indication: Anaesthesia Procedure
Propofol
Dosage: 200 mg bolus + 400 mg/h
Indication: Anaesthesia Procedure
Fentanyl
Dosage: 0.15 mg
Indication: Anaesthesia Procedure
Neostigmine
Dosage: 3.2 mg
Indication: Anaesthesia Procedure
Nitrous Oxide
Dosage: 66%
Indication: Anaesthesia Procedure
Rocuronium Bromide
Dosage: 25 mg
Indication: Anaesthesia Procedure
Diclofenac
Dosage: 75 mg
Indication: Anaesthesia Procedure
Ranitidine
Dosage: 50 mg
Indication: Anaesthesia Procedure
Glycopyrrolate
Dosage: 0.6 mg
Indication: Anaesthesia Procedure
Possible Neostigmine side effects in 21 year old female
Reported by a physician from Austria on 2012-04-26
Patient: 21 year old female, weighing 65.0 kg (143.0 pounds)
Reactions: Drug Interaction, Atrioventricular Dissociation
Drug(s) suspected as cause:
Rocuronium Bromide
Indication: Anaesthesia
Nitrous Oxide (IN Oxygen)
Glycopyrrolate
Ranitidine
Indication: Anaesthesia
Diclofenac Sodium
Indication: Anaesthesia
Midazolam
Administration route: Oral
Indication: Anaesthesia
Fentanyl
Indication: Anaesthesia
Propofol
Indication: Anaesthesia
Neostigmine
Possible Neostigmine side effects in 75 year old female
Reported by a physician from Uruguay on 2012-02-01
Patient: 75 year old female
Reactions: Abdominal Pain, Death, Dehydration, Electrolyte Imbalance, Blood Creatinine Increased, Constipation
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Bisacodyl
Dosage: 10 ml
Indication: Constipation
Metoclopramide
Dosage: 60 mg
Lactulose Solution Usp, 10 G / 15 ML
Dosage: 40 ml
Administration route: Oral
Indication: Constipation
Morphine
Dosage: 90 mg
Morphine
Dosage: 280 mg
Administration route: Oral
Indication: Metastatic Pain
Dexamethasone
Dosage: 16 mg
Administration route: Oral
Indication: Metastatic Pain
Neostigmine
Indication: Constipation
Methadone HCL
Dosage: 70 mg
Administration route: Oral
Indication: Metastatic Pain
Acetaminophen
Dosage: 975 mg
Administration route: Oral
Indication: Metastatic Pain
Possible Neostigmine side effects in 75 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-01-25
Patient: 75 year old female
Reactions: Dysarthria, Erythema, Sinus Tachycardia, Blood Pressure Decreased
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Nimbex
Dosage: 1 per 1 day
Indication: Anaesthesia
Start date: 2011-09-13
End date: 2011-09-13
Cefamandole Sodium
Dosage: 1 per 1 day
Indication: Prophylaxis
Start date: 2011-09-13
End date: 2011-09-13
Sufenta Preservative Free
Dosage: 1 per 1 day
Indication: Anaesthesia
Start date: 2011-09-13
End date: 2011-09-13
Sevoflurane
Dosage: 1 per 1 day
Indication: Anaesthesia
Start date: 2011-09-13
End date: 2011-09-13
Tramadol HCL
Dosage: once a day
Indication: Product Used FOR Unknown Indication
Start date: 2011-09-13
End date: 2011-09-13
Neostigmine
Dosage: 1 per 1 day
Indication: Product Used FOR Unknown Indication
Start date: 2011-09-13
End date: 2011-09-13
Diprivan
Dosage: 1 per 1 day
Indication: Product Used FOR Unknown Indication
Start date: 2011-09-13
End date: 2011-09-13
Atropine
Dosage: 1 per 1 day
Indication: Product Used FOR Unknown Indication
Start date: 2011-09-13
End date: 2011-09-13
Possible Neostigmine side effects in 75 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-01-23
Patient: 75 year old female
Reactions: Dysarthria, Blood Pressure Decreased, Erythema, Sinus Tachycardia
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Sufenta Preservative Free
Indication: Anaesthesia
Start date: 2011-09-13
End date: 2011-09-13
Sevoflurane
Indication: Anaesthesia
Start date: 2011-09-13
End date: 2011-09-13
Neostigmine
Indication: Product Used FOR Unknown Indication
Start date: 2011-09-13
End date: 2011-09-13
Tramadol HCL
Dosage: once a day
Indication: Product Used FOR Unknown Indication
Start date: 2011-09-13
End date: 2011-09-13
Diprivan
Indication: Product Used FOR Unknown Indication
Start date: 2011-09-13
End date: 2011-09-13
Nimbex
Indication: Anaesthesia
Start date: 2011-09-13
End date: 2011-09-13
Cefamandole Sodium
Indication: Prophylaxis
Start date: 2011-09-13
End date: 2011-09-13
Atropine
Indication: Product Used FOR Unknown Indication
Start date: 2011-09-13
End date: 2011-09-13
Possible Neostigmine side effects in 47 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-13
Patient: 47 year old male, weighing 52.0 kg (114.4 pounds)
Reactions: Electrocardiogram ST Segment Elevation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Propofol
Indication: Anaesthesia
Droperidol
Indication: Anaesthesia
Fentanyl-100
Dosage: fentanyl-bupivacaine 0.125% at 20 ug-hr (minus 1) (total of 89 mg)
Indication: Anaesthesia
Sevoflurane
Indication: Anaesthesia
Atropine
Indication: Anaesthesia
Vecuronium Bromide
Indication: Anaesthesia
Neostigmine
Indication: Anaesthesia
Possible Neostigmine side effects in 16 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-23
Patient: 16 year old male
Reactions: Pulmonary Oedema, Hypoxia, Laryngospasm
Drug(s) suspected as cause:
Propofol
Dosage: 150 mg, single
Indication: Anaesthesia
Glycopyrrolate / 00196201 /
Dosage: 0.5 mg, single
Indication: Anaesthesia
Fentanyl-100
Dosage: 100 ug, single
Indication: Anaesthesia
Nitrous Oxide
Indication: Anaesthesia
Atracurium Besylate
Dosage: 30 mg, single
Indication: Anaesthesia
Sevoflurane
Indication: Anaesthesia
Neostigmine
Dosage: 2.5 mg, single
Indication: Anaesthesia
Possible Neostigmine side effects in 67 year old male
Reported by a health professional (non-physician/pharmacist) from Greece on 2011-11-17
Patient: 67 year old male, weighing 70.0 kg (154.0 pounds)
Reactions: Chylothorax, Sepsis, Acute Respiratory Distress Syndrome, Acute Respiratory Failure
Adverse event resulted in: death
Drug(s) suspected as cause:
Acetaminophen
Indication: Product Used FOR Unknown Indication
Remifentanil
Indication: Product Used FOR Unknown Indication
Start date: 2011-10-04
End date: 2011-10-04
Fentanyl
Indication: Product Used FOR Unknown Indication
Start date: 2011-10-04
End date: 2011-10-04
Morphine
Indication: Product Used FOR Unknown Indication
Atropine
Indication: Product Used FOR Unknown Indication
Neostigmine
Indication: Product Used FOR Unknown Indication
Cisatracurium Besylate
Indication: Product Used FOR Unknown Indication
Suprane
Indication: Maintenance of Anaesthesia
Start date: 2011-10-04
Propofol
Indication: Product Used FOR Unknown Indication
Start date: 2011-10-04
Metoclopramide
Indication: Product Used FOR Unknown Indication
Possible Neostigmine side effects in 67 year old male
Reported by a health professional (non-physician/pharmacist) from Greece on 2011-11-09
Patient: 67 year old male, weighing 70.0 kg (154.0 pounds)
Reactions: Chylothorax, Sepsis, Acute Respiratory Distress Syndrome, Acute Respiratory Failure
Adverse event resulted in: death
Drug(s) suspected as cause:
Morphine
Indication: Product Used FOR Unknown Indication
Atropine
Indication: Product Used FOR Unknown Indication
Remifentanil
Indication: Product Used FOR Unknown Indication
Start date: 2011-10-04
End date: 2011-10-04
Propofol
Indication: Product Used FOR Unknown Indication
Start date: 2011-10-04
Acetaminophen
Indication: Product Used FOR Unknown Indication
Fentanyl-100
Indication: Product Used FOR Unknown Indication
Start date: 2011-10-04
End date: 2011-10-04
Neostigmine
Indication: Product Used FOR Unknown Indication
Cisatracurium Besylate
Indication: Product Used FOR Unknown Indication
Suprane
Indication: Maintenance of Anaesthesia
Start date: 2011-10-04
Metoclopramide
Indication: Product Used FOR Unknown Indication
Possible Neostigmine side effects in 62 year old male
Reported by a health professional (non-physician/pharmacist) from Greece on 2011-11-09
Patient: 62 year old male, weighing 82.0 kg (180.4 pounds)
Reactions: Acute Respiratory Distress Syndrome, Acute Respiratory Failure, Shock
Adverse event resulted in: death
Drug(s) suspected as cause:
Ondasetron
Indication: Product Used FOR Unknown Indication
Start date: 2011-10-04
End date: 2011-10-04
Acetaminophen
Indication: Product Used FOR Unknown Indication
Start date: 2011-10-04
End date: 2011-10-04
Morphine
Indication: Product Used FOR Unknown Indication
Start date: 2011-10-04
End date: 2011-10-04
Suprane
Indication: Maintenance of Anaesthesia
Start date: 2011-10-04
End date: 2011-10-04
Lactated Ringer's
Indication: Product Used FOR Unknown Indication
Start date: 2011-10-04
End date: 2011-10-04
Metoclopramide
Indication: Product Used FOR Unknown Indication
Start date: 2011-10-04
End date: 2011-10-04
Naropin
Indication: Product Used FOR Unknown Indication
Start date: 2011-10-04
End date: 2011-10-04
Naropin
Start date: 2011-10-04
End date: 2011-10-04
Remifentanil
Indication: Analgesic Therapy
Start date: 2011-10-04
End date: 2011-10-04
Propofol
Indication: Product Used FOR Unknown Indication
Start date: 2011-10-04
End date: 2011-10-04
Atropine
Indication: Neuromuscular Blockade Reversal
Start date: 2011-10-04
End date: 2011-10-04
Neostigmine
Indication: Neuromuscular Blockade Reversal
Start date: 2011-10-04
End date: 2011-10-04
Ranitidine
Indication: Product Used FOR Unknown Indication
Start date: 2011-10-04
End date: 2011-10-04
Morphine
Start date: 2011-10-04
End date: 2011-10-04
Sodium Chloride 0.9% IN Plastic Container
Indication: Product Used FOR Unknown Indication
Start date: 2011-10-04
End date: 2011-10-04
Naropin
Start date: 2011-10-04
End date: 2011-10-04
Cisatracurium Besylate
Indication: Hypotonia
Start date: 2011-10-04
End date: 2011-10-04
Fentanyl-100
Indication: Product Used FOR Unknown Indication
Start date: 2011-10-04
End date: 2011-10-04
Possible Neostigmine side effects in 16 year old male
Reported by a physician from United States on 2011-11-09
Patient: 16 year old male
Reactions: Hypoxia, Pulmonary Oedema, Laryngospasm
Drug(s) suspected as cause:
Atracurium Besylate
Indication: Anaesthesia
Sevoflurane
Indication: Anaesthesia
Fentanyl-100
Dosage: fentanyl-bupivacaine 0.125% at 20 ug-hr (minus 1) (total of 89 mg)
Indication: Anaesthesia
Propofol
Indication: Anaesthesia
Neostigmine
Indication: Anaesthesia
Glycopyrrolate / 00196201 /
Indication: Anaesthesia
Possible Neostigmine side effects in 47 year old male
Reported by a physician from United States on 2011-11-09
Patient: 47 year old male
Reactions: Electrocardiogram ST Segment Elevation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Droperidol
Indication: Anaesthesia
Vecuronium Bromide
Indication: Anaesthesia
Atropine
Indication: Anaesthesia
Propofol
Indication: Anaesthesia
Sevoflurane
Indication: Anaesthesia
Fentanyl-100
Dosage: fentanyl-bupivacaine 0.125% at 20 ug-hr (minus 1) (total of 89 mg)
Indication: Anaesthesia
Neostigmine
Indication: Anaesthesia
Possible Neostigmine side effects in 62 year old male
Reported by a health professional (non-physician/pharmacist) from Greece on 2011-10-27
Patient: 62 year old male, weighing 82.0 kg (180.4 pounds)
Reactions: Acute Respiratory Distress Syndrome, Acute Respiratory Failure, Pulmonary Granuloma
Adverse event resulted in: death
Drug(s) suspected as cause:
Metoclopramide
Indication: Product Used FOR Unknown Indication
Start date: 2011-10-04
End date: 2011-10-04
Atropine
Indication: Neuromuscular Blockade Reversal
Start date: 2011-10-04
End date: 2011-10-04
Acetaminophen
Indication: Product Used FOR Unknown Indication
Start date: 2011-10-04
End date: 2011-10-04
Neostigmine
Indication: Neuromuscular Blockade Reversal
Start date: 2011-10-04
End date: 2011-10-04
Lactated Ringer's
Indication: Product Used FOR Unknown Indication
Start date: 2011-10-04
End date: 2011-10-04
Naropin
Indication: Product Used FOR Unknown Indication
Start date: 2011-10-04
End date: 2011-10-04
Naropin
Start date: 2011-10-04
End date: 2011-10-04
Naropin
Start date: 2011-10-04
End date: 2011-10-04
Cisatracurium Besylate
Indication: Hypotonia
Start date: 2011-10-04
End date: 2011-10-04
Sodium Chloride 0.9% IN Plastic Container
Indication: Product Used FOR Unknown Indication
Start date: 2011-10-04
End date: 2011-10-04
Morphine
Start date: 2011-10-04
End date: 2011-10-04
Remifentanil
Indication: Analgesic Therapy
Start date: 2011-10-04
End date: 2011-10-04
Ranitidine
Indication: Product Used FOR Unknown Indication
Start date: 2011-10-04
End date: 2011-10-04
Morphine
Indication: Product Used FOR Unknown Indication
Start date: 2011-10-04
End date: 2011-10-04
Suprane
Indication: Maintenance of Anaesthesia
Start date: 2011-10-04
End date: 2011-10-04
Ondasetron
Indication: Product Used FOR Unknown Indication
Start date: 2011-10-04
End date: 2011-10-04
Other drugs received by patient: Fentanyl-100; Propofol
Possible Neostigmine side effects in 67 year old male
Reported by a health professional (non-physician/pharmacist) from Greece on 2011-10-27
Patient: 67 year old male, weighing 70.0 kg (154.0 pounds)
Reactions: Chylothorax, Sepsis, Acute Respiratory Distress Syndrome, Acute Respiratory Failure, Pulmonary Granuloma
Adverse event resulted in: death
Drug(s) suspected as cause:
Metoclopramide
Indication: Product Used FOR Unknown Indication
Cisatracurium Besylate
Indication: Product Used FOR Unknown Indication
Neostigmine
Indication: Product Used FOR Unknown Indication
Remifentanil
Indication: Product Used FOR Unknown Indication
Start date: 2011-10-04
End date: 2011-10-04
Acetaminophen
Indication: Product Used FOR Unknown Indication
Atropine
Indication: Product Used FOR Unknown Indication
Suprane
Indication: Maintenance of Anaesthesia
Start date: 2011-10-04
Morphine
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Fentanyl-100; Propofol
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