Gonal-f RFF Redi-ject Side Effects
Generic name: follicle stimulating hormone
Medically reviewed by Drugs.com. Last updated on Mar 2, 2025.
Note: This document provides detailed information about Gonal-f RFF Redi-ject Side Effects associated with follicle stimulating hormone. Some dosage forms listed on this page may not apply specifically to the brand name Gonal-f RFF Redi-ject.
Applies to follicle stimulating hormone: subcutaneous solution.
Other dosage forms:
Precautions
It is very important that your doctor check your progress at regular visits while you are using this medicine, to make sure that the medicine is working properly and to check for unwanted effects. Blood and urine tests, semen testing, and ultrasound examinations are needed to check for any unwanted effects caused by this medicine.
Call your doctor right away if you think you have become pregnant while you are using this medicine. You may have a higher risk of an ectopic pregnancy if you get pregnant while undergoing IVF or ICSI procedures. An ectopic pregnancy can be a serious and life-threatening condition. It can also cause problems that may make it harder for you to become pregnant in the future.
This medicine may increase your risk of having a blood clot, heart attack, or stroke. This is more likely in people who already have heart disease. Contact your doctor right away if you have chest pain or tightness, a fast or irregular heartbeat, unusual flushing or warmth of the skin, increased coughing, trouble with breathing, a sudden difficulty with breathing at night, or abnormal swelling in your ankles or legs. These could be symptoms of serious heart problems or blood clots.
For women who are using this medicine:
- If your doctor has asked you to record your basal body temperature (BBT) each day, make sure that you understand how to do this. Carefully follow your doctor's instructions.
- This medicine may increase your risk of having a problem with the ovaries called ovarian hyperstimulation syndrome (OHSS), which can be life-threatening. Check with your doctor right away if you have bloating, diarrhea, severe nausea, stomach pain, rapid weight gain, or vomiting.
- This medicine may cause more than one egg to be released from your ovary at the same time. This means you may become pregnant with more than one baby. Talk with your doctor about this possibility before you start using this medicine.
- This medicine may cause serious lung problems (eg, atelectasis or acute respiratory distress syndrome). Check with your doctor right away if you have blue lips, fingernails, or skin, chest tightness, coughing, difficulty or fast breathing, fever, rapid heartbeat, or trouble breathing.
- This medicine may increase your risk of having ovarian cancer if you received it more than one time to get pregnant. Talk to your doctor about this risk.
Serious side effects
Along with its needed effects, follicle stimulating hormone (the active ingredient contained in Gonal-f RFF Redi-ject) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking follicle stimulating hormone:
More common side effects
- bloating
- diarrhea
- severe nausea or vomiting
- severe stomach pain
- stomach or pelvic discomfort, aching, or heaviness
- weight gain that is rapid
Less common side effects
- heavy non-menstrual vaginal bleeding
- redness, pain, or swelling at the injection site
- unusual tiredness or weakness
Incidence not known
- difficulty with breathing
- pain in the chest, groin, or legs, especially the calves
- severe, sudden headache
- slurred speech
- sudden loss of coordination
- sudden, severe weakness or numbness in the arm or leg
- trouble breathing
- vision changes
Other side effects
Some side effects of follicle stimulating hormone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common side effects
- blemishes on the skin
- headache
- pimples
Less common side effects
- body aches or pain
- chills
- difficulty having a bowel movement (stool)
- dizziness
- dry skin
- fast or racing heart
- fever
- hair loss
- hives
- quick or shallow breathing
- rash
- swelling of the breasts or breast soreness in both females and males
Incidence not known
- breast tenderness
- normal menstrual bleeding occurring earlier, possibly lasting longer than expected
For healthcare professionals
Applies to follicle stimulating hormone: injectable powder for injection, injectable solution, subcutaneous powder for injection, subcutaneous solution.
General adverse events
The most common adverse events were headache, ovarian cysts and local injection site reactions (e.g. pain, erythema, hematoma, swelling and/or irritation at the site of injection).[Ref]
Genitourinary
- Very common (10% or more): Multiple births (up to 35.1%), ovarian cysts, mild to moderate ovarian enlargement
- Common (1% to 10%): Mild or moderate OHSS (including symptomatology), intermenstrual bleeding, pelvic discomfort, ovarian hyperstimulation, ectopic pregnancy, miscarriage, gynecomastia (males), varicocele, epididymal cyst, vaginal hemorrhage, pelvic pain
- Uncommon (0.1% to 1%): Severe OHSS (including symptomatology), breast complaints, metrorrhagia, ovarian cyst, ovarian enlargement, ovarian torsion, uterine enlargement, vaginal hemorrhage
- Rare (less than 0.1%): Complications of severe OHSS, adnexal torsion associated with ovarian enlargement
- Frequency not reported: Ectopic pregnancy, miscarriage, multiple gestations
- Postmarketing reports: Breast tenderness[Ref]
Gastrointestinal
- Very common (10% or more): Abdominal pain (up to 23.2%), abdomen enlarged (13.9%)
- Common (1% to 10%): Abdominal distension, abdominal discomfort, nausea, vomiting, diarrhea, constipation, abdominal pain lower, flatulence
- Uncommon (0.1% to 1%): Swollen abdomen[Ref]
Nervous system
- Very common (10% or more): Headache (up to 26.5%), dizziness
- Common (1% to 10%): Fatigue[Ref]
Local
- Very common (10% or more): Injection site reactions (e.g. pain, erythema, hematoma, swelling and/or irritation at the site of injection)[Ref]
Dermatologic
- Common (1% to 10%): Acne, rash, dermoid cyst
- Frequency not reported: Bruising, swelling, erythema, urticaria, pruritus[Ref]
Metabolic
- Common (1% to 10%): Weight gain[Ref]
Hypersensitivity
- Uncommon (0.1% to 1%): Generalized hypersensitivity reaction
- Very rare (less than 0.01%): Mild to severe hypersensitivity reactions including anaphylactic reactions and shock[Ref]
Cardiovascular
- Very rare (less than 0.01%): Thromboembolism, usually associated with severe OHSS[Ref]
Other
Respiratory
- Very rare (less than 0.01%): Exacerbation or aggravation of asthma[Ref]
See also:
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Xyosted
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Pregnyl
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Depo-Testosterone
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Menopur
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HCG
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Clomiphene
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References
1. (2002) "Product Information. Follistim (follicle stimulating hormone)." Organon
2. (2002) "Product Information. Gonal-F (follicle stimulating hormone)." Serono Laboratories Inc
3. Cerner Multum, Inc. "UK Summary of Product Characteristics."
4. Cerner Multum, Inc. "Australian Product Information."
More about Gonal-f RFF Redi-ject (follicle stimulating hormone)
Patient resources
Other brands
Gonal-f, Follistim AQ, Follistim AQ Cartridge, Gonal-f RFF
Professional resources
Other brands
Gonal-f, Follistim AQ, Gonal-f RFF
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Further information
Gonal-f RFF Redi-ject side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.