Fertinex Side Effects

Generic Name: urofollitropin

Note: This page contains information about the side effects of urofollitropin. Some of the dosage forms included on this document may not apply to the brand name Fertinex.

Not all side effects for Fertinex may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to urofollitropin: powder for solution

In addition to its needed effects, some unwanted effects may be caused by urofollitropin (the active ingredient contained in Fertinex). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking urofollitropin:

More common
  • Abdominal or pelvic pain
  • bloating (mild)
Less common or rare
  • Abdominal or stomach pain (severe)
  • bloating (moderate to severe)
  • chest pain or trouble breathing
  • decreased amount of urine
  • feeling of indigestion
  • headache, sudden and severe
  • nausea, vomiting, or diarrhea (continuing or severe)
  • pelvic pain (severe)
  • shortness of breath or wheezing
  • skin rash or hives
  • swelling of the arms or lower legs
  • weight gain (rapid)

Some of the side effects that can occur with urofollitropin may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Less common or rare
  • Breast tenderness
  • diarrhea (mild)
  • headache
  • hot flashes
  • nausea
  • redness, pain, or swelling at the injection site
  • vomiting

After you stop taking this drug, it is possible that you may still experience side effects that need medical attention. If you notice any of the following side effects check with your doctor immediately:

  • Abdominal or stomach pain (severe)
  • bloating (moderate to severe)
  • decreased amount of urine
  • feeling of indigestion
  • nausea, vomiting, or diarrhea (continuing or severe)
  • pelvic pain (severe)
  • shortness of breath
  • swelling of the lower legs
  • weight gain (rapid)

For Healthcare Professionals

Applies to urofollitropin: injectable powder for injection, intramuscular powder for injection, subcutaneous powder for injection


Cardiovascular side effects have include venous thrombophlebitis, cerebral vascular occlusion (stroke), and arterial occlusion resulting in loss of limb. In rare cases, thromboembolic events have resulted in death.


Dermatologic side effects have included dry skin, body rash, hair loss, and hives.


Gastrointestinal side effects have included nausea, vomiting, diarrhea, abdominal cramps, and bloating.


General side effects have included headache and abdominal pain.


Mild to moderate uncomplicated ovarian enlargement has been reported to generally regress without treatment within two or three weeks.

Severe OHSS may progress over one to several days to become a serious medical event. Severe OHSS is characterized by an apparent dramatic increase in vascular permeability which can result in a rapid accumulation of fluid in the peritoneal cavity, thorax, and potentially the pericardium. Early warning signs include severe pelvic pain, nausea, vomiting, and weight gain. Cases of OHSS may include abdominal pain, abdominal distension, nausea, vomiting, diarrhea, severe ovarian enlargement, weight gain, dyspnea, and oliguria. Clinical evaluation may reveal hypovolemia, hemoconcentration, electrolyte imbalances, ascites, hemoperitoneum, pleural effusions, hydrothorax, acute pulmonary distress, and thromboembolic events. Transient liver function test abnormalities have also been associated with OHSS.

Genitourinary side effects have included mild to moderate ovarian enlargement sometimes accompanied by abdominal distention and/or abdominal pain (20%), severe ovarian hyperstimulation syndrome (OHSS)(6%), breast tenderness, and ovarian cysts.


Local side effects have included pain, rash, swelling, and/or irritation at the site of injection.


Oncologic side effects have included infrequent reports of neoplasms (both benign and malignant) in women who have undergone multiple drug regimens for ovulation induction. However, a causal relationship has not been established.


Other side effects have included reactions including chills, musculoskeletal aches, joint pains, malaise, headache, and fatigue.

It is not clear whether the febrile reactions were pyrogenic responses or possible allergic reactions.


Respiratory side effects have included atelectasis, pulmonary embolism, pulmonary infarction, and acute respiratory distress syndrome. In rare cases, pulmonary complications have resulted in death.

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