Follistim AQ Side Effects
Please note - some side effects for Follistim AQ may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
Side Effects of Follistim AQ - for the Consumer
Follistim AQ
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 Follistim AQ:
Seek medical attention right away if any of these SEVERE side effects occur when using Follistim AQ:Breast tenderness; dizziness; dry skin; flu-like symptoms (fever, chills, muscle aches, joint pain, nausea); general body discomfort; headache; stomach discomfort; swelling.
TopSevere allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal vaginal bleeding; chest pain; diarrhea; fast, slow, or irregular heartbeat; indigestion; infrequent urination; nausea; pain or redness at the injection site; severe pelvic pain; sharp pain in the groin or calves; stomach pain or bloating; sudden, severe headache; vomiting; weakness; weight gain.
Follistim AQ Side Effects - for the Professional
Follistim AQ
Assisted Reproductive Technologies (ART)
Rates of adverse events from an open-label, non-controlled, multicenter study in 60 women undergoing COH for IVF or ICSI with Follistim® AQ Cartridge (follitropin beta injection) administered with the Follistim Pen® are summarized in Table 4.
| Adverse Event | Follistim® AQ Cartridge n=60 |
|---|---|
| Abdominal pain | 28% |
| Flatulence | 27% |
| Abdominal pain, gynecological | 25% |
| Nausea | 17% |
| Breast pain, female | 15% |
| Injection site reaction | 10% |
| Abdomen enlarged | 8% |
| Back pain | 7% |
| Constipation | 5% |
| Headache | 5% |
| Ovarian pain | 5% |
Ovulation Induction
Rates of adverse events from an open-label, non-controlled, multicenter study in 43 clomiphene-resistant women with chronic anovulation (WHO group II) undergoing Ovulation Induction with Follistim® AQ Cartridge (follitropin beta injection) administered with the Follistim Pen® are summarized in Table 5.
| Adverse Event | Follistim® AQ Cartridge n=43 |
|---|---|
| Ovarian hyperstimulation syndrome | 9% |
| Abdominal pain | 5% |
| Injection site reaction | 5% |
| Sinusitis | 5% |
| Upper respiratory tract infection | 5% |
The following adverse events have been reported in women treated with gonadotropins: pulmonary and vascular complications, hemoperitoneum, adnexal torsion (as a complication of ovarian enlargement), dizziness, tachycardia, dyspnea, tachypnea, febrile reactions, flu-like symptoms including fever, chills, musculoskeletal aches, joint pains, nausea, headache and malaise, breast tenderness, and dermatological symptoms (dry skin, erythema, body rash, hair loss and hives).
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.
Congenital Anomalies
The incidence of congenital malformations after Assisted Reproductive Technologies (ART) may be slightly higher than after spontaneous conception. This slightly higher incidence is thought to be related to differences in parental characteristics (e.g., maternal age, sperm characteristics) and to the higher incidence of multiple gestations after ART. There are no indications that the use of gonadotropins during ART is associated with an increased risk of congenital malformations.
TopSide Effects by Body System
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 resources:
Gonal-F - Includes detailed dosage instructions.
Follistim - Includes detailed dosage instructions.
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