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Cetrotide (Cetrorelix) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Cetrotide (Cetrorelix) 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 (20)
Life Threatening Events (2)

Reports by Reaction Type

Ovarian Hyperstimulation Syndrome (9)Loss of Consciousness (5)Hyponatraemia (3)Ascites (3)Pruritus (2)Vaginal Haemorrhage (2)Diplopia (2)Ovarian Torsion (2)Gastrointestinal Perforation (2)Rash (2)Chills (1)Abortion Spontaneous (1)

Possible Cetrotide side effects in 33 year old female

Reported by a physician from Malaysia on 2012-08-13

Patient: 33 year old female

Reactions: Anaemia

Drug(s) suspected as cause:
Cetrotide
    Indication: in Vitro Fertilisation

Fentanyl
    Indication: Product Used FOR Unknown Indication

Gonal-F
    Indication: in Vitro Fertilisation
    Start date: 2012-05-07
    End date: 2012-05-11

Propofol
    Indication: Product Used FOR Unknown Indication



Possible Cetrotide side effects in female

Reported by a physician from Finland on 2012-07-16

Patient: female

Reactions: Diplopia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cetrotide

Other drugs received by patient: Fostimon; Menopur



Possible Cetrotide side effects in female

Reported by a physician from Finland on 2012-07-10

Patient: female

Reactions: Diplopia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cetrotide

Other drugs received by patient: Menopur; Fostimon



Possible Cetrotide side effects in female

Reported by a consumer/non-health professional from Canada on 2012-07-03

Patient: female

Reactions: Vaginal Haemorrhage

Drug(s) suspected as cause:
Cetrotide
    Indication: Infertility

Gonal-F
    Indication: Infertility

Gonal-F



Possible Cetrotide side effects in female

Reported by a consumer/non-health professional from Canada on 2012-06-06

Patient: female

Reactions: Vaginal Haemorrhage

Drug(s) suspected as cause:
Cetrotide
    Indication: Product Used FOR Unknown Indication

Gonal-F

Gonal-F
    Indication: Product Used FOR Unknown Indication



Possible Cetrotide side effects in female

Reported by a physician from Serbia on 2012-05-07

Patient: female

Reactions: Pruritus, Rash

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cetrotide

Other drugs received by patient: Puregon 100; Menopur



Possible Cetrotide side effects in female

Reported by a physician from Serbia on 2012-04-20

Patient: female

Reactions: Pruritus, Rash

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cetrotide

Other drugs received by patient: Puregon 100; Menopur



Possible Cetrotide side effects in 31 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-03-22

Patient: 31 year old female

Reactions: Human Chorionic Gonadotropin Increased, Hyponatraemia, Ovarian Hyperstimulation Syndrome, Ascites

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cetrotide
    Dosage: sc
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-10-20
    End date: 2011-10-26

Chorionic Gonadotropin
    Dosage: 5000 iu;once;im
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-10-26
    End date: 2011-10-26

Puregon (Follitropin Beta / 01348901 / )
    Dosage: sc
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-10-19
    End date: 2011-10-25



Possible Cetrotide side effects in 31 year old female

Reported by a physician from Czech Republic on 2012-03-20

Patient: 31 year old female

Reactions: Tinnitus, Injection Site Erythema, Chills, Paraesthesia, Loss of Consciousness

Drug(s) suspected as cause:
Cetrotide

Other drugs received by patient: Prednisone; Annopyrin (Anopyrin); Gonal-F



Possible Cetrotide side effects in 38 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-03-09

Patient: 38 year old female

Reactions: Gastrointestinal Perforation, Ovarian Torsion, Iatrogenic Injury, Ovarian Hyperstimulation Syndrome, Pelvic Fluid Collection

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Cetrotide
    Dosage: 0.25 mg;qd;sc
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-09-16
    End date: 2010-09-27

Chorionic Gonadotropin
    Dosage: 5000 iu;once;im
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-09-27
    End date: 2010-09-27

Puregon (Follitropin Beta / 01348901 / )
    Dosage: 200 iu;qd;sc
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-09-16
    End date: 2010-09-26



Possible Cetrotide side effects in 31 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-03-08

Patient: 31 year old female

Reactions: Hyponatraemia, Ovarian Hyperstimulation Syndrome, Ascites

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cetrotide
    Dosage: sc
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-10-20
    End date: 2011-10-26

Chorionic Gonadotropin
    Dosage: 5000 iu;once;im
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-10-26
    End date: 2011-10-26

Puregon (Follitropin Beta / 01348901 / )
    Dosage: sc
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-10-19
    End date: 2011-10-25



Possible Cetrotide side effects in female

Reported by a pharmacist from Italy on 2012-03-08

Patient: female

Reactions: Ovarian Hyperstimulation Syndrome, Loss of Consciousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cetrotide
    Indication: Ovulation Induction
    Start date: 2011-10-06
    End date: 2011-10-07

Chorionic Gonadotropin
    Indication: Ovulation Induction
    Start date: 2011-10-07
    End date: 2011-10-07

Gonal-F
    Indication: Ovulation Induction
    Start date: 2011-10-01
    End date: 2011-10-08

Other drugs received by patient: Levothyroxine Sodium



Possible Cetrotide side effects in 38 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-03-08

Patient: 38 year old female

Reactions: Gastrointestinal Perforation, Ovarian Torsion, Ovarian Hyperstimulation Syndrome

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Cetrotide
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-09-16
    End date: 2010-09-27

Gonadotrophine Chorionique Endo
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-09-27
    End date: 2010-09-27

Puregon
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-09-16
    End date: 2010-09-26



Possible Cetrotide side effects in 31 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-03-07

Patient: 31 year old female

Reactions: Hyponatraemia, Ovarian Hyperstimulation Syndrome, Ascites

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cetrotide
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-10-20
    End date: 2011-10-26

Chorionic Gonadotropin
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-10-26
    End date: 2011-10-26

Puregon
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-10-19
    End date: 2011-10-25



Possible Cetrotide side effects in female

Reported by a pharmacist from Italy on 2012-03-05

Patient: female

Reactions: Ovarian Hyperstimulation Syndrome, Loss of Consciousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cetrotide
    Indication: Ovulation Induction
    Start date: 2011-10-06
    End date: 2011-10-07

Chorionic Gonadotropin
    Indication: Ovulation Induction
    Start date: 2011-10-07
    End date: 2011-10-07

Gonal-F
    Indication: Ovulation Induction
    Start date: 2011-10-01
    End date: 2011-10-08

Other drugs received by patient: Levothyroxine Sodium; Levothyroxine Sodium



Possible Cetrotide side effects in female

Reported by a pharmacist from Italy on 2012-02-07

Patient: female

Reactions: Ovarian Hyperstimulation Syndrome, Loss of Consciousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cetrotide
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-10-06
    End date: 2011-10-07

Chorionic Gonadotropin
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-10-07
    End date: 2011-10-07

Gonal-F
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-10-01
    End date: 2011-10-08

Other drugs received by patient: Levothyroxine Sodium



Possible Cetrotide side effects in female

Reported by a pharmacist from Italy on 2012-01-30

Patient: female

Reactions: Ovarian Hyperstimulation Syndrome, Loss of Consciousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cetrotide
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-10-06
    End date: 2011-10-07

Chorionic Gonadotropin
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-10-07
    End date: 2011-10-07

Gonal-F
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-10-01
    End date: 2011-10-08

Other drugs received by patient: Levothyroxine Sodium



Possible Cetrotide side effects in 19 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-03

Patient: 19 year old female

Reactions: Back Pain, Pelvic Pain

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cetrotide
    Indication: Ovulation Induction

Gonal-F
    Indication: Ovulation Induction

Lupron
    Indication: Assisted Fertilisation

Other drugs received by patient: Enoxaparin



Possible Cetrotide side effects in female

Reported by a physician from United Kingdom on 2011-12-19

Patient: female

Reactions: Abortion Spontaneous

Drug(s) suspected as cause:
Cetrotide

Other drugs received by patient: Chorionic Gonadotropin



Possible Cetrotide side effects in female

Reported by a individual with unspecified qualification from France on 2011-10-17

Patient: female

Reactions: Antinuclear Antibody Positive, Mydriasis, Amaurosis

Drug(s) suspected as cause:
Aspirin
    Dosage: (160 mg for a year oral)
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-01-01

Cetrotide
    Dosage: (0.25 mg, from day 1 to day 12 subcutaneous)
    Indication: Ovulation Induction
    Start date: 2010-11-01
    End date: 2010-11-29

Folic Acid
    Dosage: (04 mg, to be stopped in case of ineffective stimulation oral)
    Administration route: Oral
    Indication: Vitamin Supplementation
    Start date: 2010-11-01
    End date: 2010-11-29

Gonal-F
    Dosage: (225 iu qd, from day 2 to day 6 subcutaneous)
    Indication: Ovulation Induction
    Start date: 2010-11-01
    End date: 2010-11-29

Menopur
    Dosage: (75 iu tid, from day 7 to day 12 subcutaneous)
    Indication: Ovulation Induction
    Start date: 2010-11-01
    End date: 2010-11-29

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