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Menotropins Side Effects

For the Consumer

Applies to menotropins: injection solution reconstituted, subcutaneous solution reconstituted

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Breast pain.
  • Enlarged breasts.
  • A fast heartbeat.
  • Yellow skin or eyes.
  • Fast breathing.
  • Pale skin.
  • Change in color of skin to a bluish color like on the lips, nail beds, fingers, or toes.
  • Flu-like signs.
  • Ovarian hyperstimulation syndrome (OHSS) is a very bad side effect that may happen in some women who use this drug. Call your doctor right away if you have very bad stomach pain or bloating; very upset stomach, throwing up, or loose stools (diarrhea); a big weight gain; shortness of breath; or change in how much urine is passed.
  • Blood clots have happened with this drug. Sometimes, these blood clots have been deadly. Call your doctor right away if you have chest, arm, back, neck, or jaw pain or pressure; coughing up blood; numbness or weakness on 1 side of your body, trouble speaking or thinking, change in balance, or change in eyesight; shortness of breath; or swelling, warmth, or pain in the leg or arm.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Irritation where the shot is given.
  • Upset stomach.
  • Headache.
  • Belly pain.
  • Stomach cramps.
  • Feeling full.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

For Healthcare Professionals

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

General

The most frequently reported adverse drug reactions reported are abdominal pain, headache, injection site reactions, and injection site pain[Ref]

Genitourinary

Very common (10% or more): Multiple pregnancy (35.3%)
Common (1% to 10%): Ovarian Hyperstimulation Syndrome (OHSS), abnormal ovarian enlargement, ovarian disease, vaginal hemorrhage, pelvic pain, breast pain, ectopic pregnancy
Postmarketing reports: Ovarian cyst, breast complaints (including breast tenderness, breast discomfort and breast swelling)
Frequency not reported: Ovarian torsion[Ref]

Gastrointestinal

Common (1% to 10%): Abdominal pain, abdominal cramps, enlarged abdomen, nausea and vomiting, diarrhea, fullness and pain
Postmarketing reports: Nausea, abdominal pain lower, abdominal distension, abdominal discomfort
Frequency not reported: Diarrhea[Ref]

Immunologic

Common (1% to 10%): Infection
Frequency not reported: Formation of antibodies[Ref]

Local

Common (1% to 10%): Injection site pain/reaction, injection site inflammation, injection site edema[Ref]

Nervous system

Common (1% to 10%): Headache
Postmarketing reports: Dizziness[Ref]

Respiratory

Common (1% to 10%): Dyspnea[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Thrombophlebitis, deep vein thrombosis
Postmarketing reports: Hot flush[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity[Ref]

Dermatologic

Postmarketing reports: Acne, rash, pruritus[Ref]

Musculoskeletal

Postmarketing reports: Arthralgia[Ref]

Ocular

Postmarketing reports: Visual disorders (blurred vision, vision impairment including amaurosis, diplopia, mydriasis, photopsia, scotoma and vitreous floaters)[Ref]

Other

Postmarketing reports: Fatigue, pyrexia[Ref]

References

1. "Product Information. Repronex (menotropins)." Ferring Pharmaceuticals Inc, Tarrytown, NY.

2. "Product Information. Menopur (menotropins)." Ferring Pharmaceuticals Inc, Tarrytown, NY.

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

4. Cerner Multum, Inc. "Australian Product Information." O 0

Some side effects of menotropins may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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