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 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 2012-05-12
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 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: Product Quality Issue, Postpartum Haemorrhage, Maternal Exposure Timing Unspecified
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 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
|
