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Neostigmine (Neostigmine) - Side Effect Reports to FDA

 
 



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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