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Pregnyl (Chorionic Gonadotropin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Pregnyl (Chorionic Gonadotropin) 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 (18)
Death (4)
Life Threatening Events (1)

Reports by Reaction Type

Ovarian Hyperstimulation Syndrome (6)Benign Hydatidiform Mole (5)Drug Ineffective (4)Ovarian Torsion (4)Maternal Exposure During Pregnancy (3)Photosensitivity Reaction (2)Rash Pruritic (2)Dizziness (2)Abortion Induced (2)Rash Maculo-Papular (2)Asthma (1)Foetal Exposure During Pregnancy (1)

Possible Pregnyl side effects in

Reported by a physician from United States on 2012-08-26

Patient:

Reactions: Adverse Event

Drug(s) suspected as cause:
Pregnyl

Other drugs received by patient: Hexadrol



Possible Pregnyl side effects in

Reported by a physician from Philippines on 2012-08-23

Patient:

Reactions: Asthma, Anaphylactic Reaction, Petechiae

Drug(s) suspected as cause:
Pregnyl



Possible Pregnyl side effects in

Reported by a consumer/non-health professional from United States on 2012-08-02

Patient:

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Pregnyl



Possible Pregnyl side effects in

Reported by a physician from United States on 2012-07-25

Patient:

Reactions: Drug Ineffective

Adverse event resulted in: death

Drug(s) suspected as cause:
Pregnyl



Possible Pregnyl side effects in

Reported by a physician from Turkey on 2012-07-18

Patient:

Reactions: Drug Ineffective, Maternal Exposure During Pregnancy, Abortion

Drug(s) suspected as cause:
Clomiphene Citrate
    Dosage: 50-150 mg
    Indication: Ovulation Induction

Pregnyl
    Dosage: 10000 iu
    Indication: Ovulation Induction

Puregon
    Dosage: 75 iu - 675 iu
    Indication: Ovulation Induction



Possible Pregnyl side effects in

Reported by a physician from Turkey on 2012-07-18

Patient:

Reactions: Drug Ineffective, Maternal Exposure During Pregnancy, Ectopic Pregnancy

Drug(s) suspected as cause:
Clomiphene Citrate
    Dosage: 50-150 mg
    Indication: Ovulation Induction

Pregnyl
    Dosage: 10000 iu
    Indication: Ovulation Induction

Puregon
    Dosage: 75 iu - 675 iu
    Indication: Ovulation Induction



Possible Pregnyl side effects in

Reported by a physician from Turkey on 2012-07-18

Patient:

Reactions: Foetal Exposure During Pregnancy, Foetal Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Clomiphene Citrate
    Dosage: 50-150 mg
    Indication: Ovulation Induction

Pregnyl
    Dosage: 10000 iu
    Indication: Ovulation Induction

Puregon
    Dosage: 75 iu - 675 iu
    Indication: Ovulation Induction



Possible Pregnyl side effects in female

Reported by a physician from Japan on 2012-04-26

Patient: female, weighing 62.0 kg (136.4 pounds)

Reactions: Ovarian Torsion, Ovarian Hyperstimulation Syndrome, Benign Hydatidiform Mole

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clomiphene Citrate
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-02-08
    End date: 2011-02-12

Gonal-F RFF PEN
    Indication: Ovulation Disorder

Gonal-F RFF PEN
    Indication: Polycystic Ovaries
    Start date: 2011-02-14
    End date: 2011-02-19

Pregnyl
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-02-20
    End date: 2011-02-20



Possible Pregnyl side effects in female

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

Patient: female, weighing 62.0 kg (136.4 pounds)

Reactions: Ovarian Torsion, Ovarian Hyperstimulation Syndrome, Benign Hydatidiform Mole

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clomiphene Citrate
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-02-08
    End date: 2011-02-12

Gonal-F RFF PEN
    Indication: Ovulation Disorder

Gonal-F RFF PEN
    Indication: Polycystic Ovaries
    Start date: 2011-02-14
    End date: 2011-02-19

Pregnyl
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-02-20
    End date: 2011-02-20



Possible Pregnyl side effects in 31 year old female

Reported by a physician from Russian Federation on 2012-04-06

Patient: 31 year old female

Reactions: Ischaemic Stroke, Pain, Coma, Pulmonary Embolism, Ovarian Hyperstimulation Syndrome, Malaise, Overdose, Swelling, Abdominal Distension, Dizziness, Fluid Retention

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Pregnyl
    Dosage: 10000 iu;im
    Indication: in Vitro Fertilisation
    Start date: 2011-02-07
    End date: 2011-02-07

Puregon (Follitropin Beta / 01348901 / )
    Dosage: 150 iu;sc
    Indication: in Vitro Fertilisation
    Start date: 2011-01-25
    End date: 2011-02-06

Other drugs received by patient: Lucrin Depot (Leuproline Acetate); Menopur



Possible Pregnyl side effects in 25 year old female

Reported by a health professional (non-physician/pharmacist) from Russian Federation on 2012-04-02

Patient: 25 year old female

Reactions: Multi-Organ Failure, Renal Failure, Sepsis, Dizziness, Gastric Ulcer Perforation, Infectious Peritonitis

Adverse event resulted in: death, hospitalization

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

Dexamethasone
    Dosage: .25 df;qd;
    Indication: Ovarian Hyperstimulation Syndrome

Pregnyl
    Dosage: 10000 iu;qd;
    Indication: Product Used FOR Unknown Indication

Puregon (Follitropin Beta / 01348901 / )
    Dosage: 980 iu;qd;
    Indication: Assisted Fertilisation
    Start date: 2009-05-01
    End date: 2009-05-01



Possible Pregnyl side effects in female

Reported by a physician from Japan on 2012-03-20

Patient: female, weighing 62.0 kg (136.4 pounds)

Reactions: Ovarian Torsion, Ovarian Hyperstimulation Syndrome, Benign Hydatidiform Mole

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clomifene
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-02-08
    End date: 2011-02-12

Gonal-F RFF PEN
    Indication: Polycystic Ovaries
    Start date: 2011-02-14
    End date: 2011-02-19

Gonal-F RFF PEN
    Indication: Ovulation Disorder

Pregnyl
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-02-20
    End date: 2011-02-20



Possible Pregnyl side effects in 26 year old female

Reported by a physician from Japan on 2012-03-05

Patient: 26 year old female, weighing 62.0 kg (136.4 pounds)

Reactions: Abortion Threatened, Hyperemesis Gravidarum, Maternal Exposure Before Pregnancy, Ovarian Hyperstimulation Syndrome, Ovarian Neoplasm, Abortion Induced, Haemorrhage in Pregnancy, Benign Hydatidiform Mole

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gonal-F (Follitropin Alfa) (Follitropin Alfa)
    Dosage: 75 iu;qd;sc
    Indication: Ovulation Induction
    Start date: 2011-02-14
    End date: 2011-02-19

Pregnyl
    Dosage: 5000 iu;once;im
    Indication: Ovulation Induction
    Start date: 2011-02-20
    End date: 2011-02-20

Other drugs received by patient: Clomiphene Citrate; Metformin Hydrochloride



Possible Pregnyl side effects in female

Reported by a physician from Japan on 2012-03-02

Patient: female, weighing 62.0 kg (136.4 pounds)

Reactions: Ovarian Torsion, Maternal Exposure During Pregnancy, Abortion Induced, Ovarian Hyperstimulation Syndrome, Benign Hydatidiform Mole

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clomifene
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-02-08
    End date: 2011-02-12

Gonal-F RFF PEN
    Indication: Ovulation Disorder

Gonal-F RFF PEN
    Indication: Polycystic Ovaries
    Start date: 2011-02-14
    End date: 2011-02-19

Pregnyl
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-02-20
    End date: 2011-02-20



Possible Pregnyl side effects in 24 year old male

Reported by a physician from Kazakhstan on 2012-01-06

Patient: 24 year old male

Reactions: Body Temperature Increased, Ascites, Hepatosplenomegaly

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pregnyl
    Dosage: 1500 iu;biw; im
    Indication: Azoospermia
    Start date: 2011-09-03
    End date: 2011-10-06

Pregnyl
    Dosage: 1500 iu;biw; im
    Indication: Infertility Female
    Start date: 2011-09-03
    End date: 2011-10-06



Possible Pregnyl side effects in 35 year old female

Reported by a pharmacist from United States on 2011-12-01

Patient: 35 year old female

Reactions: Therapeutic Response Decreased

Drug(s) suspected as cause:
Pregnyl

Other drugs received by patient: Doxycycline



Possible Pregnyl side effects in 37 year old female

Reported by a physician from Singapore on 2011-10-13

Patient: 37 year old female

Reactions: Photosensitivity Reaction, Rash Maculo-Papular, Rash Pruritic

Drug(s) suspected as cause:
Pregnyl



Possible Pregnyl side effects in 37 year old female

Reported by a physician from Singapore on 2011-10-04

Patient: 37 year old female

Reactions: Photosensitivity Reaction, Rash Maculo-Papular, Rash Pruritic

Drug(s) suspected as cause:
Pregnyl

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