July 2, 2016
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Ovidrel

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Ovidrel




Ovidrel Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Ovidrel (choriogonadotropin alfa) Injection is used to treat certain fertility problems in women. It is the hormone (hCG) that causes the growth and release of a mature egg (ovulation). It is usually used in combination with another hormone (FSH) that helps cause healthy ovaries to produce eggs. Common side effects include nausea, vomiting, mild abdominal pain/swelling, headache, and pain/bruising/redness/swelling at the injection site.

Ovidrel PreFilled Syringe comes in a 250 g dose which is administered one day following the last dose of the follicle stimulating agent. Ovidrel may interact with gonadorelin. Tell your doctor all medications and supplements you use. If you become pregnant or think you may be pregnant after treatment with Ovidrel, stop using this medication and tell your doctor. This drug must not be used during pregnancy because it may harm a fetus. It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Our Ovidrel (choriogonadotropin alfa) 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Ovidrel in Detail - Patient Information: Side Effects

Stop using HCG and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these signs of a blood clot: pain, warmth, redness, numbness, or tingling in your arm or leg; confusion, extreme dizziness, or severe headache.

Some women using this medicine have developed a condition called ovarian hyperstimulation syndrome (OHSS), especially after the first treatment cycle. OHSS can be a life-threatening condition. Call your doctor right away if you have any of the following symptoms of OHSS:

  • severe pelvic pain;
  • swelling of the hands or legs;
  • stomach pain and swelling;
  • shortness of breath;
  • weight gain;
  • diarrhea;
  • nausea or vomiting; or
  • urinating less than normal.

This medication can cause early puberty in young boys. Call your doctor if a boy using this medicine shows early signs of puberty, such as a deepened voice, pubic hair growth, and increased acne or sweating.

Less serious side effects may include:

  • headache;
  • feeling restless or irritable;
  • mild swelling or water weight gain;
  • depression;
  • breast tenderness or swelling; or
  • pain, swelling, or irritation where the injection is given.

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 Ovidrel (Choriogonadotropin Alfa Injection)

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Ovidrel Overview - Patient Information: Side Effects

SIDE EFFECTS: Nausea, vomiting, mild abdominal pain/swelling, headache, and pain/bruising/redness/swelling at the injection site may occur. If any of these effects persist or worsen, tell your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: unusual vaginal bleeding.

This medication may cause a condition known as ovarian hyperstimulation syndrome (OHSS). This condition may occur during treatment or after treatment is finished. Rarely, serious OHSS causes fluid to suddenly build up in the stomach, chest, and heart area. Seek immediate medical attention if you develop the following very serious side effects: severe pain/swelling in the lower abdominal (pelvic) area, severe nausea/vomiting/diarrhea, sudden shortness of breath, sudden/rapid weight gain, decrease in the amount of urine.

Seek immediate medical attention if any of these very unlikely but very serious side effects occur: chest/jaw/left arm pain, sudden severe headache, confusion, weakness on one side of the body, slurred speech, swelling of the hands/ankles/feet, sudden vision changes (e.g., double vision, loss of vision), pain/redness/swelling in the legs, sudden difficulty breathing.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Ovidrel (Choriogonadotropin Alfa Injection)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Ovidrel FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

(see WARNINGS)

The safety of Ovidrel® was examined in four clinical studies that treated 752 patients of whom 335 received Ovidrel® 250 μg following follicular recruitment with gonadotropins. When patients enrolled in four clinical studies (3 in ART and one in OI) were injected subcutaneously with either Ovidrel® or an approved urinary-derived hCG, 14.6 % (49 of 335 patients) in the Ovidrel® 250 μg group experienced application site disorders compared to 28% (92 of 328 patients) in the approved u-hCG group. Adverse events reported for Ovidrel® 250 μg occurring in at least 2% of patients (regardless of causality) are listed in Table 9 for the 3 ART studies and in Table 10 for the single OI study.

Table 9: Incidence of Adverse Events of r-hCG in ART (Studies 7648, 7927, 9073)

Body System Ovidrel® 250 μg
(n=236)
Preferred Term Incidence Rate % (n)
At Least One Adverse Event 33.1% (78)
Application Site Disorders 14.0% (33)
Injection Site Pain 7.6% (18)
Injection Site Bruising 4.7% (11)
Gastro-Intestinal System Disorders 8.5% (20)
Abdominal Pain 4.2% (10)
Nausea 3.4% ( 8)
Vomiting 2.5% ( 6)
Secondary Terms (Post-Operative Pain) 4.7% (11)
Post-Operative Pain 4.7% (11)

Adverse events not listed in Table 9 that occurred in less than 2% of patients treated with Ovidrel® 250 μg whether or not considered causally related to Ovidrel®, included: injection site inflammation and reaction, flatulence, diarrhea, hiccup, ectopic pregnancy, breast pain, intermenstrual bleeding, vaginal hemorrhage, cervical lesion, leukorrhea, ovarian hyperstimulation, uterine disorders, vaginitis, vaginal discomfort, body pain, back pain, fever, dizziness, headache, hot flashes, malaise, paraesthesias, rash, emotional lability, insomnia, upper respiratory tract infection, cough, dysuria, urinary tract infection, urinary incontinence, albuminuria, cardiac arrhythmia, genital moniliasis, genital herpes, leukocytosis, heart murmur and cervical carcinoma.

Table 10: Incidence of Adverse Events of r-hCG in Ovulation Induction (Study 8209)

Body System Ovidrel® 250 μg
(n=99)
Preferred Term Incidence Rate % (n)
At Least One Adverse Event 26.2% (26)
Application Site Disorders 16.2% (16)
  Injection site pain 8.1% (8)
  Injection site inflammation 2.0% (2)
  Injection site bruising 3.0% (3)
  Injection site reaction 3.0% (3)
Reproductive Disorders, Female 7.1% (7)
  Ovarian cyst 3.0% (3)
  Ovarian hyperstimulation 3.0% (3)
Gastro-Intestinal System Disorders 4.0% (4)
  Abdominal pain 3.0% (3)

Additional adverse events not listed in Table 10 that occurred in less than 2% of patients treated with Ovidrel® 250 μg, whether or not considered causally related to Ovidrel®, included: breast pain, flatulence, abdominal enlargement, pharyngitis, upper respiratory tract infection, hyperglycemia and pruritis.

The following medical events have been reported subsequent to pregnancies resulting from hCG therapy in controlled clinical studies:

  1. Spontaneous Abortion
  2. Ectopic Pregnancy
  3. Premature Labor
  4. Postpartum Fever
  5. Congenital Abnormalities

Of 125 clinical pregnancies reported following treatment with FSH and Ovidrel® 250 μg or 500 μg, three were associated with a congenital anomaly of the fetus or newborn. Among patients receiving Ovidrel® 250 μg, cranial malformation was detected in the fetus of one woman and a chromosomal abnormality (47, XXX) in another. These events were judged by the investigators to be of unlikely or unknown relation to treatment. These three events represent an incidence of major congenital malformations of 2.4%, which is consistent with the reported rate for pregnancies resulting from natural or assisted conception. In a woman who received Ovidrel® 500 μg, one birth in a set of triplets was associated with Down's syndrome and atrial septal defect. This event was considered to be unrelated to the study drug.

The following adverse reactions have been previously reported during menotropin therapy:

  1. Pulmonary and vascular complications (see “WARNINGS”)
  2. Adnexal torsion (as a complication of ovarian enlargement)
  3. Mild to moderate ovarian enlargement
  4. Hemoperitoneum

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.

Post-Marketing Experience

In addition to adverse events reported from clinical trials, the following events have been reported during post-marketing use of Ovidrel®. Therefore, these events were reported from a population of uncertain size, the frequency or causal relationship to Ovidrel® cannot be reliably determined.

  • Cases of allergic reactions, including anaphylactic reactions and mild reversible skin rashes have been reported in patients treated with Ovidrel® since market introduction. The causal relationship is unknown.
  • Thromboembolic events both in association with, and separate from, the Ovarian Hyperstimulation Syndrome (see ''WARNINGS'')

Read the entire FDA prescribing information for Ovidrel (Choriogonadotropin Alfa Injection)

Ovidrel - User Reviews

Ovidrel User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Ovidrel sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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