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Follistim

Last reviewed on RxList: 2/24/2017
Follistim Side Effects Center

Last reviewed on RxList 12/11/2015

Follistim AQ (follitropin beta injection) contains follicle stimulating hormone (FSH), a naturally occurring hormone and is used to stimulate a follicle (egg) to develop and mature. Follistim AQ is used when a woman desires pregnancy and her ovaries can produce a follicle but hormonal stimulation is not sufficient to make the follicle mature. Follistim AQ is also used to stimulate the development of multiple eggs for in vitro fertilization, and can be used by men to increase the production of sperm. Common side effects of Follistim AQ include headache, stomach pain, bloating, nausea, injection site reactions (redness, pain, bruising, or irritation), breast tenderness or pain or swelling, dizziness, numbness or tingly feeling, pelvic pain/discomfort or tenderness, runny or stuffy nose, sore throat, acne, or skin rash.

A starting dose of 150 to 225 IU of Follistim AQ is recommended for at least the first four days of treatment. After this, the dose may be adjusted for the individual patient based upon their ovarian response. It is unknown if other medications will interact with Follistim AQ. Tell your doctor all medications and supplements you use. Stop using Follistim AQ when you become pregnant. This medication must not be used during pregnancy. If you think you may be pregnant, tell your doctor. It is unknown if this drug passes into breast milk. Because of the possible harm to a nursing infant, consult your doctor before breastfeeding.

Our Follistim AQ (follitropin beta injection) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

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Follistim Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some women using this medicine develop ovarian hyperstimulation syndrome (OHSS), a potentially life-threatening condition. Stop using this medicine and call your doctor right away if you have symptoms of OHSS during or shortly after using follicle stimulating hormone:

  • severe pain in your lower stomach, nausea, vomiting, diarrhea;
  • bloating, rapid weight gain;
  • little or no urination; or
  • trouble breathing.

Also call your doctor at once if you have:

  • severe pelvic pain on one side;
  • a cough with bloody mucus;
  • fever, sore throat, swollen glands;
  • a lump or swelling in your testicles;
  • signs of acute respiratory distress syndrome--fever with shortness of breath or rapid breathing; or
  • signs of a blood clot--sudden numbness or weakness, problems with vision or speech, swelling or redness in an arm or leg.

Common side effects may include:

  • redness, swelling, or bruising where an injection was given;
  • an ovarian cyst;
  • headache, tiredness;
  • breast pain or swelling;
  • stuffy nose, sneezing, sinus pain;
  • acne; or
  • nausea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Follistim (Follitropin Beta)

QUESTION

Men and women are equally likely to have fertility problems. See Answer
Follistim Professional Information

SIDE EFFECTS

Assisted Reproductive Technologies (ART)

Rates of adverse events from a randomized, assessor-blind, group comparative, multicenter safety and efficacy study of Follistim®in 989 infertile women treated with in vitro fertilization with Follistim®or urofollitropin after pituitary suppression with a GnRH agonist are summarized in Table 5.

Table 5. Incidence of Adverse Clinical Experiences ( > 1%)

Adverse Event Follistim® (n=591)
Miscarriage 11.0%
Ovarian Hyperstimulation Syndrome 5.2%
Ectopic pregnancy 3.0%
Abdominal pain 2.5%
Injection site pain 1.7%
Vaginal hemorrhage 1.5%

Ovulation Induction

Rates of adverse events from a randomized, assessor-blind, group comparative, multi-center safety and efficacy study of Follistim® in 172 chronic anovulatory women who failed to ovulate and/or conceive during clomiphene citrate treatment are summarized in Table 6.

Table 6. Incidence of Adverse Clinical Experiences ( > 1%)

Adverse Event Follistim® (n=105)
Miscarriage 9.5%
Ovarian Hyperstimulation Syndrome 7.6%
Abdominal discomfort 2.9%
Abdominal pain, lower 2.9%
Abdominal pain 1.9%
Ovarian cyst 2.9%

The following adverse events have been reported in women treated with gonado tropins: 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, mus culoskeletal aches, joint pains, nausea, headache and malaise, breast tenderness, and dermatological symptoms (dry skin, erythema, body rash, hair loss, and hives)

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

Congenital Anomalies

The incidence of congenital malformations after Assisted Reproductive Technologies (ART) may be slightly higher than after spontaneous conception. This slightly higher incidence is thought to be related to differences in parental characteristics (e.g., maternal age, sperm characteristics) and to the higher incidence of multiple gestations after ART. There are no indications that the use of gonadotropins during ART is associated with an increased risk of congenital malformations.

Drug Abuse And Dependence

There have been no reports of abuse or dependence with Follistim® AQ (follitropin beta) (follitropin beta injection).

Read the entire FDA prescribing information for Follistim (Follitropin Beta)

Related Resources for Follistim

Read the Follistim User Reviews »

© Follistim Patient Information is supplied by Cerner Multum, Inc. and Follistim Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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