Ovidrel Side Effects Center

Last updated on RxList: 8/5/2022
Ovidrel Side Effects Center

What Is Ovidrel?

Ovidrel (choriogonadotropin alfa) Injection is the hormone (hCG) that causes the growth and release of a mature egg (ovulation) used to treat certain fertility problems in women. Ovidrel is usually used in combination with another hormone (FSH) that helps cause healthy ovaries to produce eggs.

What Are Side Effects of Ovidrel?

Common side effects of Ovidrel include:

  • nausea
  • vomiting
  • mild abdominal pain/swelling
  • headache
  • restlessness
  • irritability
  • water weight gain
  • depression
  • breast tenderness or swelling
  • injection site reactions (pain, bruising, redness, swelling, or irritation)

Ovidrel may cause serious side effects including:

  • pain, warmth, redness, numbness or tingling in your arm or leg,
  • confusion,
  • extreme dizziness, and
  • severe headache

Specific to women:

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

Tell the doctor if you have any side effect that bothers you or that does not go away.

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Ovidrel

Ovidrel PreFilled Syringe comes in a 250 µg dose which is administered one day following the last dose of the follicle stimulating agent.

What Drugs, Substances, or Supplements Interact with Ovidrel?

Ovidrel may interact with gonadorelin. Tell your doctor all medications and supplements you use.

Ovidrel During Pregnancy and Breastfeeding

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.

Additional Information

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.

SLIDESHOW

Fertility Options: Types, Treatments, and Costs See Slideshow
Ovidrel 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. Call your doctor right away if you have symptoms of OHSS:

  • severe stomach pain or pelvic pain;
  • rapid weight gain, swelling around your waist, feeling short of breath;
  • severe nausea and vomiting, diarrhea; or
  • little or no urination.

Call your doctor at once if you have:

  • fluid build-up around the lungs or stomach--rapid weight gain, stomach pain and bloating, pain when you breathe, feeling short of breath while lying down, cough with foamy mucus, rapid heartbeats;
  • signs of a blood clot--sudden numbness or weakness on one side of the body, chest pain, problems with vision or speech, pain or swelling in one leg; or
  • early puberty in boys--enlarged testicles and penis, facial hair, a deepened voice.

Common side effects may include:

  • headache, depression;
  • feeling restless or irritable;
  • swelling;
  • breast tenderness or swelling; or
  • pain where the medicine was injected.

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)

QUESTION

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

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

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