Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
ADVERSE REACTIONS For males and females: Immune system disorders Hypersensitivity reactions, both localized and systemic in nature, including anaphylaxis have been reported.
In rare cases, generalized rash or fever may occur (see CONTRAINDICATIONS and WARNINGS ).
If a hypersensitivity reaction is suspected, discontinue PREGNYL and assess for other potential causes for the event.
Psychiatric disorders Irritability Restlessness Depression Nervous system disorders Headache General disorders and administration site conditions PREGNYL may cause reactions at the site of injection, such as bruising, pain, redness, swelling and itching.
Occasionally, allergic reactions have been reported, mostly manifesting as pain and/or rash at the injection site (see CONTRAINDICATIONS and WARNINGS ).
Edema Fatigue In the female: Vascular disorders In rare instances, thromboembolism has been associated with FSH/hCG therapy, usually associated with severe OHSS (see WARNINGS ).
Respiratory, thoracic and mediastinal disorders Hydrothorax, as a complication of severe OHSS (see WARNINGS ).
Gastrointestinal disorders Abdominal pain and gastrointestinal symptoms such as nausea and diarrhea, related to mild OHSS.
Ascites, as a complication of severe OHSS (see WARNINGS ).
Reproductive system and breast disorders Unwanted ovarian hyperstimulation, mild or severe Ovarian Hyperstimulation Syndrome (see WARNINGS ).
WARNINGS Use hCG in conjunction with gonadotropin therapy only if the physician is experienced with infertility problems and is familiar with the criteria for patient selection, contraindications, warnings, precautions, and adverse reactions described in the package insert for gonadotropins.
Gonadotropin therapy, including hCG, requires a certain time commitment by physicians and supportive health professionals, and requires the availability of appropriate monitoring facilities (see PRECAUTIONS/Laboratory Tests ).
Safe and effective induction of ovulation with use of PREGNYL requires monitoring of ovarian response with serum estradiol and transvaginal ultrasound on a regular basis.
Anaphylaxis Anaphylaxis has been reported with urinary-derived hCG products.
Ovarian Hyperstimulation Syndrome (OHSS) Ovarian Hyperstimulation Syndrome (OHSS) is a medical event distinct from uncomplicated ovarian enlargement and may progress rapidly to become a serious medical event.
Like all medications, Pregnyl can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: