DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Follistim (Follitropin Beta) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Assisted Reproductive Technologies (ART)

Rates of adverse events from a randomized, assessor-blind, group comparative, multicenter safety and efficacy study of Follistim® (Protocol 37608) in 989 infertile women treated with in vitro fertilization with Follistim® or Metrodin® after pituitary suppression with a GnRH agonist are summarized in Table VIII.

Table VIII. Incidence of Adverse Clinical Experiences (>1%) that Occurred in Protocol 37608
Adverse Event Follistim ®
(n=591)
Metrodin ®
(n=398)
Miscarriage11.0%11.3%
Ovarian Hyperstimulation Syndrome5.2%4.3%
Ectopic pregnancy3.0%3.8%
Abdominal pain2.5%2.3%
Injection site pain1.7%0.5%
Vaginal hemorrhage1.5%0.8%

Ovulation Induction

Rates of adverse events from a randomized, assessor-blind, group comparative, multicenter safety and efficacy study of Follistim® (Protocol 37609) in 172 chronic anovulatory women who failed to ovulate and/or conceive during clomiphene citrate treatment are summarized in Table IX.

Table IX. Incidence of Adverse Clinical Experiences (>1%) that Occurred in Protocol 37609
Adverse Event Follistim ®
(n=105)
Metrodin ®
(n=67)
Miscarriage9.5%9.0%
Ovarian Hyperstimulation Syndrome7.6%4.5%
Abdominal discomfort2.9%1.5%
Abdominal pain, lower2.9%1.5%
Abdominal pain1.9%3.0%
Ovarian cyst2.9%3.0%

The following adverse events have been reported in women treated with gonadotropins: pulmonary and vascular complications (see WARNINGS), hemoperitoneum, adnexal torsion (as a complication of ovarian enlargement), dizziness, tachycardia, dyspnea, tachypnea, febrile reactions, flu-like symptoms including fever, chills, musculoskeletal aches, joint pains, nausea, headache and malaise, breast tenderness, and dermatological symptoms (dry skin, body rash, hair loss and hives).

There have been infrequent reports of ovarian neoplasms, both benign and malignant, in women who have undergone multiple drug regimens for ovulation induction; however, a causal relationship has not been established.



REPORTS OF SUSPECTED FOLLISTIM SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Follistim. The information is not vetted and should not be considered as verified clinical evidence.

Possible Follistim side effects / adverse reactions in 39 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-25

Patient: 39 year old female

Reactions: Eosinophilic Pneumonia Acute

Adverse event resulted in: hospitalization

Suspect drug(s):
Progesterone
    Indication: in Vitro Fertilisation
    Start date: 2010-11-09
    End date: 2010-11-23

Chorionic Gonadotropin
    Indication: Ovulation Induction

Follistim
    Indication: Ovulation Induction

Menopur
    Indication: Ovulation Induction

Ganirelix Acetate Injection
    Indication: Ovulation Induction

Other drugs received by patient: Clomiphene Citrate



Possible Follistim side effects / adverse reactions in 39 year old female

Reported by a physician from United States on 2012-01-30

Patient: 39 year old female

Reactions: Eosinophilic Pneumonia Acute

Adverse event resulted in: hospitalization

Suspect drug(s):
Ganirelix Acetate Injection
    Indication: Ovulation Induction

Progesterone
    Indication: in Vitro Fertilisation
    Start date: 2010-11-09
    End date: 2010-11-23

Follistim
    Indication: Ovulation Induction

Chorionic Gonadotropin
    Indication: Ovulation Induction

Menopur
    Indication: Ovulation Induction

Other drugs received by patient: Clomiphene Citrate



See index of all Follistim side effect reports >>

Drug label data at the top of this Page last updated: 2008-11-19

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017