Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 2/17/2022
Fertinex Side Effects Center

What Is Fertiniex?

Fertinex (urofollitropin for injection) is a preparation of Follicle Stimulating Hormone (FSH) used for the stimulation of follicular recruitment and development and the induction of ovulation in patients with polycystic ovary syndrome and infertility, who have failed to respond or conceive following adequate clomiphene citrate therapy. Fertinex and hCG may also be used to stimulate the development of multiple follicles in ovulatory patients undergoing Assisted Reproductive Technologies (ART) such as in vitro fertilization. The brand name Fertinex is discontinued, but generic versions may be available.

What Are Side Effects of Fertiniex?

Common side effects of Fertinex (urofollitropin for injection) include:

  • headache
  • stomach or abdominal pain
  • abdominal cramps
  • nausea
  • vomiting
  • bloating
  • injection site reactions (redness, pain, rash, or swelling
  • breast tenderness/pain
  • dizziness
  • diarrhea
  • hot flashes
  • dry skin
  • rash,
  • hair loss, or
  • hives

Dosage for Fertiniex

Over the course of treatment, doses of Fertinex may range between 75 IU to 300 IU per day depending on the individual patient response.

What Drugs, Substances, or Supplements Interact with Fertiniex?

Fertinex may interact with other drugs. Tell your doctor all medications and supplements you use.

Fertiniex During Pregnancy or Breastfeeding

Fertinex is not recommended for use during pregnancy. It may harm a fetus. This drug passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Fertinex (urofollitropin for 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.


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Fertinex Consumer Information

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

Some women using this medicine develop a condition called ovarian hyperstimulation syndrome (OHSS), especially after the first treatment. OHSS can be a life threatening condition. Stop using urofollitropin, do not have sexual intercourse, and call your doctor right away if you have any of the following symptoms of OHSS:

  • stomach pain, bloating;
  • nausea, vomiting, diarrhea;
  • rapid weight gain, especially in your face and midsection;
  • little or no urinating; or
  • pain when you breathe, rapid heart rate, feeling short of breath (especially when lying down).

Also call your doctor at once if you have signs of a stroke or blood clot, such as:

  • sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
  • chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
  • pain, swelling, warmth, or redness in one or both legs.

Common side effects may include:

  • stomach cramps or bloating;
  • headache, general pain;
  • nausea;
  • trouble breathing;
  • hot flashes; or
  • mild pelvic pain, pain after an egg is removed for in-vitro fertilization.

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 Fertinex (Urofollitropin)


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Fertinex Professional Information


The following adverse reactions reported during urofollitropin therapy are listed in decreasing order of potential severity :

  1. Pulmonary and vascular complications (see WARNINGS),
  2. Ovarian Hyperstimulation Syndrome (see WARNINGS),
  3. Adnexal torsion (as a complication of ovarian enlargement),
  4. Mild to moderate ovarian enlargement,
  5. Abdominal pain,
  6. Sensitivity to urofollitropin
    (Febrile reactions which may be accompanied by chills, musculoskeletal aches, joint pains, malaise, headache, and fatigue have occurred after the administration of urofollitropin. It is not clear whether or not these were pyrogenic responses or possible allergic reactions.)
  7. Ovarian cysts,
  8. Gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal cramps, bloating),
  9. Pain, rash, swelling, and/or irritation at the site of injection,
  10. Breast tenderness,
  11. Headache,
  12. Dermatological symptoms (dry skin, body rash, hair loss, hives)
  13. Hemoperitoneum has been reported during menotropins therapy and, therefore, may also occur during urofollitropin therapy.
  14. 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.

The following medical events have been reported subsequent to pregnancies resulting from urofollitropin therapy:

  1. Ectopic Pregnancy
  2. Congenital abnormalities
    (Three incidents of chromosomal abnormalities and four birth defects have been reported following urofollitropin-hCG or urofollitropin, Pergonal® (menotropins for injection, USP)-hCG therapy in clinical trials for stimulation prior to in vitro fertilization. The aborted pregnancies included one Trisomy 13, one Trisomy 18, and one fetus with multiple congenital anomalies (hydrocephaly, omphalocele, and meningocele). One meningocele, one external ear defect, one dislocated hip and ankle, and one dilated cardiomyopathy in presence of maternal Systemic Lupus Erythematosis were reported. None of these events were thought to be drug-related. The incidence does not exceed that found in the general population).


There have been no reports of abuse or dependence with FertinexTM (urofollitropin for injection, purified).

Read the entire FDA prescribing information for Fertinex (Urofollitropin)

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

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