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Review Puregon Safety Reports submitted to FDA

Total Puregon reports: 19.
Puregon FDA safety alerts: No.
   Reported hospitalizations: 13.
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FDA Reported Puregon Side Effects: ovarian hyperstimulation syndrome, ovarian torsion, ectopic pregnancy, abortion induced, abortion spontaneous, trisomy 18, polyneuropathy, pelvic pain.
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Puregon Side Effects Report #5637699-8
Consumer or non-health professional from UNITED STATES reported PUREGON problem on Feb 08, 2008. Female patient, 38 years of age, weighting 129.5 lb, was diagnosed with ovarian hyperstimulation syndrome, blood luteinising hormone and was treated with PUREGON. After drug was administered, patient experienced the following problems/side effects: abortion spontaneous. PUREGON dosage: unknown. During the same period patient was treated with HUMEGON, PREGNYL, PREDONINE. Patient was hospitalized. Patient recovered.

Puregon Side Effects Report #5508718-4
PUREGON problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 24, 2007. Female patient, 34 years of age, was diagnosed with in vitro fertilisation, ovulation induction and was treated with PUREGON. After drug was administered, patient experienced the following problems/side effects: deep vein thrombosis. PUREGON dosage: unknown. During the same period patient was treated with ORGALUTRAN, CHORIONIC GONADOTROPIN, PROMETRIUM, MENOPUR, FEMTRACE, PROGESTERONE, PRENATAL VITAMINS. Patient was hospitalized. Patient recovered.

Puregon Side Effects Report #5528733-4
Health Professional from UNITED STATES reported PUREGON problem on June 26, 2007. Female patient, 26 years of age, weighting 142.0 lb, was diagnosed with oocyte donation and was treated with PUREGON. After drug was administered, patient experienced the following problems/side effects: ovarian hyperstimulation syndrome. PUREGON dosage: unknown. During the same period patient was treated with CHORIONIC GONADOTROPIN, REPRONEX. Patient was hospitalized. Patient recovered.

Puregon Side Effects Report #5528734-6
PUREGON problem was reported by a Health Professional from UNITED STATES on June 26, 2007. Female patient, 32 years of age, weighting 128.0 lb, was diagnosed with anovulatory cycle and was treated with PUREGON. After drug was administered, patient experienced the following problems/side effects: ovarian hyperstimulation syndrome. PUREGON dosage: unknown. During the same period patient was treated with CHORIONIC GONADOTROPIN, REPRONEX. Patient was hospitalized. Patient recovered.


Puregon Side Effects Report #5528736-X
Health Professional from UNITED STATES reported PUREGON problem on June 26, 2007. Female patient, 30 years of age, weighting 154.1 lb, was diagnosed with infertility and was treated with PUREGON. After drug was administered, patient experienced the following problems/side effects: ovarian hyperstimulation syndrome. PUREGON dosage: unknown. During the same period patient was treated with CHORIONIC GONADOTROPIN, REPRONEX. Patient was hospitalized. Patient recovered.

Puregon Side Effects Report #5528737-1
PUREGON problem was reported by a Health Professional from UNITED STATES on June 29, 2007. Female patient, 28 years of age, weighting 134.5 lb, was diagnosed with infertility male and was treated with PUREGON. After drug was administered, patient experienced the following problems/side effects: ovarian hyperstimulation syndrome. PUREGON dosage: unknown. During the same period patient was treated with CHORIONIC GONADOTROPIN. Patient was hospitalized. Patient recovered.

Puregon Side Effects Report #5498434-X
Consumer or non-health professional from UNITED STATES reported PUREGON problem on Oct 11, 2007. Female patient, 34 years of age, was diagnosed with in vitro fertilisation and was treated with PUREGON. After drug was administered, patient experienced the following problems/side effects: deep vein thrombosis. PUREGON dosage: unknown. During the same period patient was treated with ORGALUTRAN, CHORIONIC GONADOTROPIN, MENOPUR, FEMTRACE, PROMETRIUM, PROGESTERONE, PRENATAL VITAMINS. Patient was hospitalized. Patient recovered.

Puregon Side Effects Report #5475470-0
PUREGON problem was reported by a Health Professional from UNITED STATES on June 26, 2007. Female patient, 34 years of age, weighting 126.0 lb, was diagnosed with infertility male and was treated with PUREGON. After drug was administered, patient experienced the following problems/side effects: ovarian hyperstimulation syndrome. PUREGON dosage: unknown. During the same period patient was treated with CHORIONIC GONADOTROPIN, MENOPUR. Patient recovered.

Puregon Side Effects Report #5475475-X
Health Professional from UNITED STATES reported PUREGON problem on June 26, 2007. Female patient, 26 years of age, weighting 142.0 lb, was treated with PUREGON. After drug was administered, patient experienced the following problems/side effects: ovarian hyperstimulation syndrome. PUREGON dosage: unknown. During the same period patient was treated with CHORIONIC GONADOTROPIN, REPRONEX. Patient was hospitalized. Patient recovered.


Puregon Side Effects Report #5475479-7
PUREGON problem was reported by a Health Professional from UNITED STATES on June 26, 2007. Female patient, 32 years of age, weighting 128.0 lb, was diagnosed with anovulatory cycle and was treated with PUREGON. After drug was administered, patient experienced the following problems/side effects: ovarian hyperstimulation syndrome. PUREGON dosage: unknown. During the same period patient was treated with CHORIONIC GONADOTROPIN, REPRONEX. Patient was hospitalized. Patient recovered.

Puregon Side Effects Report #5475480-3
Health Professional from UNITED STATES reported PUREGON problem on June 26, 2007. Female patient, 30 years of age, weighting 154.1 lb, was treated with PUREGON. After drug was administered, patient experienced the following problems/side effects: ovarian hyperstimulation syndrome. PUREGON dosage: unknown. During the same period patient was treated with CHORIONIC GONADOTROPIN, REPRONEX. Patient was hospitalized. Patient recovered.

Puregon Side Effects Report #5397042-9
PUREGON problem was reported by a Consumer or non-health professional from UNITED STATES on July 05, 2007. Female patient, 24 years of age, was diagnosed with infertility and was treated with PUREGON. After drug was administered, patient experienced the following problems/side effects: abortion spontaneous. PUREGON dosage: unknown. During the same period patient was treated with CHORIONIC GONADOTROPHIN. Patient recovered.

Puregon Side Effects Report #5397042-9
Consumer or non-health professional from UNITED STATES reported PUREGON problem on July 05, 2007. Female patient, 24 years of age, was diagnosed with infertility and was treated with PUREGON. After drug was administered, patient experienced the following problems/side effects: abortion spontaneous. PUREGON dosage: unknown. During the same period patient was treated with CHORIONIC GONADOTROPHIN. Patient recovered.

Puregon Side Effects Report #5727494-3
PUREGON problem was reported by a Health Professional from UNITED STATES on June 29, 2007. Female patient, 28 years of age, weighting 134.5 lb, was diagnosed with infertility male and was treated with PUREGON. After drug was administered, patient experienced the following problems/side effects: ovarian hyperstimulation syndrome. PUREGON dosage: unknown. During the same period patient was treated with CHORIONIC GONADOTROPIN. Patient was hospitalized. Patient recovered.


Puregon Side Effects Report #5727508-0
Physician from UNITED STATES reported PUREGON problem on Nov 08, 2007. Female patient was diagnosed with infertility, assisted fertilisation and was treated with PUREGON. After drug was administered, patient experienced the following problems/side effects: ovarian hyperstimulation syndrome. PUREGON dosage: unknown. During the same period patient was treated with CHORIONIC GONADOTROPIN, ORGALUTRAN. Patient was hospitalized. Patient recovered.

Puregon Side Effects Report #5727509-2
PUREGON problem was reported by a Health Professional from UNITED STATES on Aug 23, 2007. Female patient, 30 years of age, was diagnosed with infertility female and was treated with PUREGON. After drug was administered, patient experienced the following problems/side effects: abortion spontaneous. PUREGON dosage: unknown. During the same period patient was treated with OVIDREL, LUPRON, MENOPUR. Patient recovered.

Puregon Side Effects Report #5727518-3
Health Professional from UNITED STATES reported PUREGON problem on Aug 23, 2007. Female patient, 28 years of age, was treated with PUREGON. After drug was administered, patient experienced the following problems/side effects: ovarian hyperstimulation syndrome. PUREGON dosage: unknown. During the same period patient was treated with GANIRELIX ACETATEECTION. Patient was hospitalized. Patient recovered.

Puregon Side Effects Report #5727525-0
PUREGON problem was reported by a Health Professional from UNITED STATES on Oct 12, 2007. Female patient, 40 years of age, weighting 130.3 lb, was diagnosed with assisted fertilisation and was treated with PUREGON. After drug was administered, patient experienced the following problems/side effects: ovarian hyperstimulation syndrome. PUREGON dosage: 525 MG DAILY SUBCUTANEOUS. During the same period patient was treated with MENOPUR, LUPRON. Patient recovered.

Puregon Side Effects Report #5727527-4
Consumer or non-health professional from UNITED STATES reported PUREGON problem on Jan 15, 2008. Female patient, 21 years of age, was treated with PUREGON. After drug was administered, patient experienced the following problems/side effects: ectopic pregnancy. PUREGON dosage: unknown. Patient recovered.


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