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Syntocinon (Oxytocin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Syntocinon (Oxytocin) 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 (17)
Life Threatening Events (4)

Reports by Reaction Type

Postpartum Haemorrhage (9)Maternal Exposure During Pregnancy (4)Agitation (2)Akathisia (2)Rhabdomyolysis (2)Hyperpyrexia (2)Chills (2)Pyrexia (2)Pallor (2)Hallucination (2)Renal Failure Acute (2)Acute Pulmonary Oedema (2)

Possible Syntocinon side effects in female

Reported by a health professional (non-physician/pharmacist) from Australia on 2012-05-12

Patient: female, weighing 93.0 kg (204.6 pounds)

Reactions: Postpartum Haemorrhage, Blood Pressure Decreased

Drug(s) suspected as cause:
Syntocinon
    Indication: Third Stage Postpartum Haemorrhage

Syntocinon
    Dosage: 0.5 iu/ml, unk
    Indication: Labour Pain
    Start date: 2012-03-27

Other drugs received by patient: Voltaren; Sodium Citrate; Acetaminophen; Tegretol



Possible Syntocinon side effects in 33 year old female

Reported by a health professional (non-physician/pharmacist) from Australia on 2012-05-12

Patient: 33 year old female, weighing 65.0 kg (143.0 pounds)

Reactions: Postpartum Haemorrhage, Maternal Exposure During Pregnancy

Drug(s) suspected as cause:
Syntocinon
    Dosage: 10 iu, unk
    Start date: 2012-03-19

Oxytocin
    Dosage: 1 iu, unk
    Start date: 2012-03-19

Syntocinon
    Dosage: 40 iu, unk
    Start date: 2012-03-19

Other drugs received by patient: Prostine



Possible Syntocinon side effects in 31 year old female

Reported by a health professional (non-physician/pharmacist) from Australia on 2012-05-12

Patient: 31 year old female

Reactions: Postpartum Haemorrhage, Maternal Exposure During Pregnancy

Drug(s) suspected as cause:
Syntocinon
    Dosage: 10 iu, unk
    Start date: 2012-03-23

Syntocinon
    Dosage: 40 iu in 1000 ml hartmens
    Start date: 2012-03-23

Syntocinon
    Dosage: 10 iu, unk
    Start date: 2012-03-23



Possible Syntocinon side effects in 33 year old female

Reported by a health professional (non-physician/pharmacist) from Australia on 2012-05-12

Patient: 33 year old female, weighing 65.0 kg (143.0 pounds)

Reactions: Postpartum Haemorrhage, Maternal Exposure During Pregnancy

Drug(s) suspected as cause:
Syntocinon
    Dosage: 10 iu, unk
    Start date: 2012-03-19

Syntocinon
    Dosage: 40 iu, unk
    Start date: 2012-03-19

Oxytocin
    Dosage: 1 iu, unk
    Start date: 2012-03-19

Other drugs received by patient: Prostine



Possible Syntocinon side effects in female

Reported by a health professional (non-physician/pharmacist) from Australia on 2012-05-07

Patient: female

Reactions: Postpartum Haemorrhage, Maternal Exposure During Pregnancy

Drug(s) suspected as cause:
Oxytocin
    Dosage: 1 ml
    Start date: 2012-03-01

Syntocinon
    Dosage: 10 iu
    Start date: 2012-03-19

Other drugs received by patient: Anti D IMI; Clotrimazole; Ferrous Sulfate TAB; Misoprostol



Possible Syntocinon side effects in female

Reported by a pharmacist from Australia on 2012-04-05

Patient: female

Reactions: Postpartum Haemorrhage

Drug(s) suspected as cause:
Syntocinon



Possible Syntocinon side effects in female

Reported by a pharmacist from Australia on 2012-04-05

Patient: female

Reactions: Postpartum Haemorrhage

Drug(s) suspected as cause:
Syntocinon



Possible Syntocinon side effects in female

Reported by a pharmacist from Australia on 2012-04-05

Patient: female

Reactions: Postpartum Haemorrhage

Drug(s) suspected as cause:
Syntocinon



Possible Syntocinon side effects in female

Reported by a pharmacist from Australia on 2012-04-05

Patient: female

Reactions: Product Quality Issue, Postpartum Haemorrhage, Maternal Exposure Timing Unspecified

Drug(s) suspected as cause:
Syntocinon



Possible Syntocinon side effects in female

Reported by a consumer/non-health professional from Italy on 2012-03-01

Patient: female

Reactions: Acute Pulmonary Oedema, Cardiac Failure, Troponin Increased, Respiratory Distress

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Naropin
    Dosage: unk
    Start date: 2010-04-23
    End date: 2010-04-23

Syntocinon
    Dosage: unk
    Start date: 2010-04-23
    End date: 2010-04-23

Omeprazole
    Dosage: 2 df, unk
    Start date: 2010-04-23
    End date: 2010-04-23

Sufenta Preservative Free
    Dosage: unk
    Start date: 2010-04-23
    End date: 2010-04-23

Nalador
    Dosage: unk
    Start date: 2010-04-23
    End date: 2010-04-23



Possible Syntocinon side effects in female

Reported by a physician from France on 2012-02-24

Patient: female

Reactions: Acute Pulmonary Oedema, Cardiac Failure, Troponin Increased, Respiratory Distress

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Nalador
    Indication: Postpartum Haemorrhage
    Start date: 2010-04-23
    End date: 2010-04-23

Naropin
    Indication: Epidural Anaesthesia
    Start date: 2010-04-23
    End date: 2010-04-23

Sufenta Preservative Free
    Indication: Epidural Anaesthesia
    Start date: 2010-04-23
    End date: 2010-04-23

Omeprazole
    Dosage: 2 vials
    Indication: Postpartum Haemorrhage
    Start date: 2010-04-23
    End date: 2010-04-23

Syntocinon
    Dosage: 5 iu/500 ml, 15 ml/hour
    Indication: Postpartum Haemorrhage
    Start date: 2010-04-23
    End date: 2010-04-23

Syntocinon
    Dosage: 5 iu/500 ml, 45 ml/hour
    Start date: 2010-04-23
    End date: 2010-04-23

Syntocinon
    Dosage: 5 iu/500 ml, 200 ml/hour
    Start date: 2010-04-23
    End date: 2010-04-23

Other drugs received by patient: Aldomet; Leucovorin Calcium; Acetaminophen; Prednisone TAB; Sulfasalazine



Possible Syntocinon side effects in 32 year old female

Reported by a physician from Sweden on 2012-01-20

Patient: 32 year old female

Reactions: Akathisia, Agitation, Rhabdomyolysis, Hyperpyrexia, Chills, Pallor, Visual Impairment, Depressed Level of Consciousness, Hallucination, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Methergine
    Dosage: 0.2 mg, unk
    Start date: 2010-02-05
    End date: 2010-02-05

Syntocinon
    Dosage: 35 iu
    Start date: 2010-02-05
    End date: 2010-02-05

Cytotec
    Indication: Off Label Use

Cytotec
    Dosage: 0.6 mg, single
    Indication: Postpartum Haemorrhage
    Start date: 2010-02-05
    End date: 2010-02-05



Possible Syntocinon side effects in 32 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-01-17

Patient: 32 year old female

Reactions: Uterine Inversion, Muscle Necrosis, Haemorrhage, Drug Ineffective, Sepsis, Vaginal Discharge, Pyrexia, Pyometra

Drug(s) suspected as cause:
Hemabate
    Indication: Postpartum Haemorrhage

Oxytocin
    Indication: Postpartum Haemorrhage

Misoprostol
    Indication: Postpartum Haemorrhage

Syntocinon
    Indication: Postpartum Haemorrhage



Possible Syntocinon side effects in 32 year old female

Reported by a physician from Sweden on 2012-01-12

Patient: 32 year old female

Reactions: Agitation, Akathisia, Rhabdomyolysis, Hyperpyrexia, Chills, Pallor, Visual Impairment, Depressed Level of Consciousness, Hallucination, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cytotec
    Dosage: 0.6 mg, single
    Indication: Postpartum Haemorrhage
    Start date: 2009-02-05
    End date: 2009-02-05

Cytotec
    Indication: Off Label Use

Syntocinon
    Dosage: 35 iu
    Start date: 2009-02-05
    End date: 2009-02-05

Methergine
    Dosage: 0.2 mg, unk
    Start date: 2009-02-05
    End date: 2009-02-05



Possible Syntocinon side effects in 25 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2011-12-21

Patient: 25 year old female

Reactions: Anaphylactic Shock

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Clindamycin HCL
    Dosage: unk
    Indication: Antibiotic Prophylaxis
    Start date: 2011-11-02
    End date: 2011-11-02

Syntocinon
    Dosage: 5 iu/1 ml , 20 iu adminsitered
    Start date: 2011-11-02
    End date: 2011-11-02

Gentamicin
    Dosage: 320 mg
    Indication: Antibiotic Prophylaxis
    Start date: 2011-11-02
    End date: 2011-11-02



Possible Syntocinon side effects in

Reported by a health professional (non-physician/pharmacist) from Italy on 2011-12-09

Patient:

Reactions: Hypotension, Cardiac Arrest, Loss of Consciousness

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Syntocinon

Other drugs received by patient: Phenylephrine HCL; Xylocaine; Midazolam HCL; Zofran; Ephedrine



Possible Syntocinon side effects in female

Reported by a physician from France on 2011-11-28

Patient: female

Reactions: Rash Pustular, Rash Generalised, Face Oedema, Lymphadenopathy, Pyrexia, Polymorphic Eruption of Pregnancy, Toxic Skin Eruption

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ferrous Sulfate TAB
    Dosage: 80mg per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-08-19
    End date: 2011-10-10

Helicidine
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-04-01
    End date: 2011-10-11

Flagyl
    Dosage: 500mg per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-09-09
    End date: 2011-09-14

Acetaminophen
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-07-01
    End date: 2011-10-11

Syntocinon
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-10-11
    End date: 2011-10-11

Augmentin '125'
    Indication: Pyrexia
    Start date: 2011-10-15
    End date: 2011-10-17

Spasfon
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-07-01
    End date: 2011-10-11

Clamoxyl IV
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-10-11
    End date: 2011-10-11

Other drugs received by patient: Celestone; Uvedose; Nifedipine; Atosiban; Unknown

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