Gonal-F Side Effects
Please note - some side effects for Gonal-F may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Side Effects of Gonal-F - for the Consumer
Gonal-f Powder
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Gonal-f Powder:
Seek medical attention right away if any of these SEVERE side effects occur when using Gonal-f Powder:Acne; breast pain or growth; discomfort at the injection site; headache; sinus infection; stomach upset; tiredness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal vaginal bleeding; calf pain or tenderness; chest pain; confusion; fever; one-sided weakness; severe or persistent shortness of breath; severe pelvic or back pain; signs of OHSS (eg, decreased urination; diarrhea; severe or persistent stomach pain, upset or bloating; nausea; sudden unexplained weight gain; vomiting); slurred speech; unusual vaginal itching, discharge, or odor; vision changes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
Gonal-f RFF Pen Solution
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Gonal-f RFF Pen Solution:
Seek medical attention right away if any of these SEVERE side effects occur when using Gonal-f RFF Pen Solution:Breast pain; discomfort, pain, or mild bruising at the injection site; headache; mild stomach pain or nausea; sinus inflammation; sore throat; stuffy nose.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal vaginal bleeding; calf pain or tenderness; chest pain; confusion; decreased urination; diarrhea; fever; one-sided weakness; severe or persistent stomach pain, upset, or bloating; severe or persistent nausea; severe pelvic or back pain; shortness of breath; slurred speech; sudden, unexplained weight gain; unusual vaginal itching, discharge, or odor; vision changes; vomiting.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
TopGonal-F Side Effects - for the Professional
Gonal-F
Women:
The safety of Gonal-F® was examined in four clinical studies that enrolled 691 patients into two studies for ovulation induction (454 patients) and two studies for ART (237 patients).
Adverse events occurring in more than 10% of patients were headache, ovarian cyst, nausea, and upper respiratory tract infection in the U.S. ovulation induction study and headache in the U.S. ART study. Adverse events (without regard to causality assessment) occurring in at least 2% of patients are listed in Table 13 and Table 14.
| Body System | Gonal-F® | Urofollitropin | ||
|---|---|---|---|---|
| Preferred Term | Patients (%) Experiencing Events | Patients (%) Experiencing Events | ||
| Treatment cycles = 288* | Treatment cycles = 277* | |||
| n=118 | n= 114 | |||
| * up to 3 cycles of therapy | ||||
| ** Severe = 0.8% of 118 patients in Study 5727 | ||||
| Reproductive, Female | ||||
| Intermenstrual Bleeding | 9.3% | 4.4% | ||
| Breast Pain Female | 4.2% | 6.1% | ||
| Ovarian Hyperstimulation** | 6.8% | 3.5% | ||
| Dysmenorrhea | 2.5% | 6.1% | ||
| Ovarian Disorder | 1.7% | 2.6% | ||
| Cervix Lesion | 2.5% | 0.9% | ||
| Menstrual Disorder | 2.5% | 0.9% | ||
| Gastro-intestinal System | ||||
| Abdominal Pain | 9.3% | 12.3% | ||
| Nausea | 13.6% | 3.5% | ||
| Flatulence | 6.8% | 8.8% | ||
| Diarrhea | 7.6% | 3.5% | ||
| Vomiting | 2.5% | 2.6% | ||
| Dyspepsia | 1.7% | 3.5% | ||
| Central and Peripheral Nervous System | ||||
| Headache | 22.0% | 20.2% | ||
| Dizziness | 2.5% | 0.0% | ||
| Neoplasm | ||||
| Ovarian Cyst | 15.3% | 28.9% | ||
| Body as a Whole- General | ||||
| Pain | 5.9% | 6.1% | ||
| Back Pain | 5.1% | 1.8% | ||
| Influenza-like Symptoms | 4.2% | 2.6% | ||
| Fever | 4.2% | 1.8% | ||
| Respiratory System | ||||
| Upper Respiratory Tract Infection | 11.9% | 7.9% | ||
| Sinusitis | 5.1% | 5.3% | ||
| Pharyngitis | 2.5% | 3.5% | ||
| Coughing | 1.7% | 2.6% | ||
| Rhinitis | 0.8% | 2.6% | ||
| Skin and Appendages | ||||
| Acne | 4.2% | 2.6% | ||
| Psychiatric | ||||
| Emotional Lability | 5.1% | 2.6% | ||
| Urinary System | ||||
| Urinary Tract Infection | 1.7% | 4.4% | ||
| Resistance Mechanism | ||||
| Moniliasis Genital | 2.5% | 0.9% | ||
| Application Site | ||||
| Injection Site Pain | 2.5% | 0.9% | ||
Additional adverse events not listed in Table 13 that occurred in 1 to 2% of Gonal-F® treated patients in the US ovulation induction study included the following: leukorrhea, vaginal hemorrhage, migraine, fatigue, asthma, nervousness, somnolence, and hypotension.
| Body System | Gonal-F® | Urofollitropin | |
|---|---|---|---|
| Preferred Term | Patients (%) Experiencing Events |
Patients (%) Experiencing Events |
|
| n=59 | n= 61 | ||
| Reproductive, Female | |||
| Intermenstrual Bleeding | 3.6% | 5.2% | |
| Leukorrhea | 1.7% | 3.4% | |
| Vaginal Hemorrhage | 3.6% | 3.4% | |
| Gastro-intestinal System | |||
| Nausea | 5.4% | 1.7% | |
| Flatulence | 3.6% | 0.0% | |
| Central and Peripheral Nervous System | |||
| Headache | 12.5% | 3.4% | |
| Body as a Whole- General | |||
| Abdominal Pain | 8.9% | 3.4% | |
| Pelvic Pain Female | 7.1% | 1.7% | |
| Respiratory System | |||
| Upper Respiratory Tract Infection | 3.6% | 1.7% | |
| Metabolic and Nutritional | |||
| Weight Increase | 3.6% | 0.0% | |
Additional adverse events not listed in Table 14 that occurred in 1 to 2% of Gonal-F® treated patients in the U.S. Assisted Reproductive Technology (ART) study included the following: D&C following delivery or abortion, dysmenorrhea, vaginal hemorrhage, diarrhea, tooth disorder, vomiting, dizziness, paraesthesia, abdomen enlarged, chest pain, fatigue, dyspnea, anorexia, anxiety, somnolence, injection site inflammation, injection site reaction, pruritus, pruritus genital, myalgia, thirst, and palpitation.
Two additional clinical studies (for ovulation induction and ART, respectively) were conducted in Europe. The safety profiles from these two studies were comparable to that of the data presented above.
Gonal-F® Multi-Dose was examined in twenty-five healthy volunteers who received 300 IU each of Gonal-F® from single-dose ampules and multi-dose vials. Overall, both presentations were well tolerated and local tolerability between the two groups was comparable. Injection site inspections revealed very rare local reactions (mild redness in one patient after single-dose injection and mild bruising in two subjects after multi-dose injection). Subjective assessments indicated minimal or mild transient pain in two and five subjects who received Gonal-F® single-dose and Gonal-F® Multi-Dose, respectively.
The following medical events have been reported subsequent to pregnancies resulting from gonadotropins in controlled clinical studies:
1. Spontaneous Abortion
2. Ectopic Pregnancy
3. Premature Labor
4. Postpartum Fever
5. Congenital Abnormalities
Two incidents of congenital cardiac malformations have been reported in children born following pregnancies resulting from treatment with Gonal-F® and hCG in Gonal-F® clinical studies 5642 and 5727. In addition, a pregnancy occurring in study 5533 following treatment with Gonal-F® and hCG was complicated by apparent failure of intrauterine growth and terminated for a suspected syndrome of congenital abnormalities. No specific diagnosis was made. The incidence does not exceed that found in the general population.
The following adverse reactions have been previously reported during menotropin therapy:
1. Pulmonary and vascular complications,
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.
Men:
The safety of Gonal-F® was examined in 3 clinical studies that enrolled 72 patients for induction of spermatogenesis and fertility of whom 56 patients received Gonal-F®. One hundred and twenty-three adverse events, including 7 serious events, were reported in 34 of the 56 patients during Gonal-F® treatment.
In Study 5844, 21 adverse events, including 4 serious adverse events, were reported by 14 of the 26 patients (53.8%) treated with Gonal-F®. Events occurring in more than one patient were varicocele (4) and injection site reactions (4). The 4 serious adverse events were testicular surgery for cryptorchidism, which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection.
In Study 6410, 3 adverse events were reported in 2 of the 8 patients (24%) treated with Gonal-F®. One serious adverse event was reported, surgery for gynecomastia which existed at baseline.
In the interim analysis of Study 6793, 18 of 22 patients (81.8%) reported a total of 99 adverse events during Gonal-F® treatment. The most common events of possible, probable, or definite relationship to study drug therapy occurring in more than 2 patients were: acne (25 events in 13 patients; 59% of patients); breast pain (4 events in 3 patients; 13.6% of patients); and fatigue, gynecomastia, and injection site pain (each of which was reported as 2 events by 2 patients; 9.1% of patients). Two serious adverse events (hospitalization for drug abuse and depression) were reported by a single patient in the interim analysis.
A total of 12,026 injections of Gonal-F® were administered by the 56 patients who received Gonal-F® in Studies 5844, 6410, and 6793 combined. The injections were well-tolerated, with no or mild reactions (redness, swelling, bruising and itching) reported by patients for 93.3% of injections. Moderate and severe reactions, consisting primarily of pain, were reported for 4.8% of injections, and no self-assessment was available for 1.9% of injections.
TopSide Effects by Body System - for Healthcare Professionals
Genitourinary
Mild to moderate uncomplicated ovarian enlargement has been reported to generally regress without treatment within two or three weeks.
Severe OHSS may progress over one to several days to become a serious medical event. Severe OHSS is characterized by an apparent dramatic increase in vascular permeability which can result in a rapid accumulation of fluid in the peritoneal cavity, thorax, and potentially the pericardium. Early warning signs include severe pelvic pain, nausea, vomiting, and weight gain. Cases of OHSS may include abdominal pain, abdominal distension, nausea, vomiting, diarrhea, severe ovarian enlargement, weight gain, dyspnea, and oliguria. Clinical evaluation may reveal hypovolemia, hemoconcentration, electrolyte imbalances, ascites, hemoperitoneum, pleural effusions, hydrothorax, acute pulmonary distress, and thromboembolic events. Transient liver function test abnormalities have also been associated with OHSS.
Genitourinary side effects have included mild to moderate ovarian enlargement sometimes accompanied by abdominal distention and/or abdominal pain, severe ovarian hyperstimulation syndrome (OHSS), miscarriage, ectopic pregnancy and ovarian cysts. Other genitourinary side effects have included intermenstrual bleeding, dysmenorrhea, breast tenderness, urinary tract infection, vaginal hemorrhage and moniliasis genital.
Respiratory
Other respiratory tract side effects have included sinusitis, pharyngitis, coughing, rhinitis, dyspnea, tachypnea and upper respiratory tract infection.
Respiratory effects have included atelectasis, pulmonary embolism, pulmonary infarction, and acute respiratory distress syndrome. In rare cases, pulmonary complications have resulted in death.
Cardiovascular
Cardiovascular effects have included venous thrombophlebitis, cerebral vascular occlusion (stroke), and arterial occlusion resulting in loss of limb. In rare cases, thromboembolic events have resulted in death.
Other cardiovascular side effects have included chest pain, palpitations, and tachycardia.
Other
Other side effects have included febrile reactions and flu-like symptoms which included fever, chills, musculoskeletal aches, joint pains, malaise, headache, and fatigue.
It is not clear whether the febrile reactions were pyrogenic responses or possible allergic reactions.
Gastrointestinal
Gastrointestinal effects have included anorexia, nausea, vomiting, diarrhea, abdominal pain, flatulence, and dyspepsia.
Local
Local side effects have included pain, rash, swelling, and/or irritation at the site of injection.
Dermatologic
Dermatologic side effects have included dry skin, body rash, hair loss, acne, pruritus and hives.
Psychiatric
Psychiatric side effects have included emotional liability.
Metabolic
Metabolic side effects have included weight gain.
Nervous system
Nervous system side effects have included headache, paresthesias somnolence, anxiety and dizziness.
Musculoskeletal
Musculoskeletal side effects have included myalgia, back pain and joint pains.
TopMore Gonal-F resources
- Gonal-F Advanced Consumer (Micromedex) - Includes Dosage Information
- Gonal-F Prescribing Information (FDA)
- Follistim Advanced Consumer (Micromedex) - Includes Dosage Information
- Follistim Consumer Overview
- Follistim AQ Consumer Overview
- Follistim AQ Prescribing Information (FDA)
- Follistim AQ MedFacts Consumer Leaflet (Wolters Kluwer)
- Gonal-f Powder MedFacts Consumer Leaflet (Wolters Kluwer)
- Gonal-f RFF Prescribing Information (FDA)
- Gonal-f RFF Pen Solution MedFacts Consumer Leaflet (Wolters Kluwer)
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