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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.

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:

Acne; breast enlargement or tenderness; headache; mild stomach pain; minor pain, bruising, swelling, or redness at the injection site;nausea; stomach discomfort; tiredness

Seek medical attention right away if any of these SEVERE side effects occur when using Follistim AQ:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal vaginal bleeding; persistent pain, bruising, swelling, or redness at the injection site; severe pelvic pain; stomach pain or bloating

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.

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Follistim AQ Side Effects - for the Professional

Follistim AQ

The following serious adverse reactions are discussed elsewhere in the labeling:

Clinical Study Experience

Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trial of another drug and may not reflect the rates observed in practice.

Ovulation Induction

In a single cycle, multi-center, assessor-blind, parallel group, comparative study, a total of 172 chronic anovulatory women who had failed to ovulate and/or conceive with clomiphene citrate therapy, were randomized and treated with Follistim (105) or a urofollitropin comparator. Adverse reactions with an incidence of greater than 2% in either treatment group are listed in Table 2.

Table 2: Common Adverse Reactions Reported at a Frequency of ≥2% in an Assessor-Blind, Comparative Study of Anovulatory Women Receiving Ovulation Induction
System Organ Class/Adverse Reactions Treatment
Number (%) of Women
Follistim
N=105
n (%)		 Comparator
N=67
n (%)
Gastrointestinal disorders
  Abdominal discomfort 3 (2.9) 1 (1.5)
  Abdominal pain 3 (2.9) 2 (3.0)
  Abdominal pain lower 3 (2.9) 1 (1.5)
Reproductive system and breast disorders
  Ovarian cyst 3 (2.9) 2 (3.0)
  Ovarian hyperstimulation syndrome 8 (7.6) 3 (4.5)
General disorders and administration site conditions
  Pyrexia 0 (0.0) 2 (3.0)

Adverse reactions reported commonly (greater than or equal to 2% of women treated with Follistim) in other ovulation induction clinical trials were headache, abdominal distension, constipation, diarrhea, nausea, pelvic pain, uterine enlargement, vaginal hemorrhage and injection site reaction.

In Vitro Fertilization/Intracytoplasmic Sperm Injection

In a single cycle, multi-center, double-blind, parallel group, comparative study, a total of 1509 women were randomized to receive controlled ovarian stimulation with either Follistim AQ Cartridge (751 women were treated with Follistim AQ Cartridge) or a comparator and pituitary suppression with a gonadotropin releasing hormone (GnRH) antagonist as part of an in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) cycle. Table 3 lists adverse reactions with an incidence of greater than 2% in the group of women treated with Follistim AQ Cartridge.

Table 3: Common Adverse Reactions Reported At a Frequency of ≥2% in a Randomized, Double-blind, Active-controlled, Comparative Study of Normal Ovulatory Women Undergoing Controlled Ovarian Stimulation as Part of an In Vitro Fertilization or Intracytoplasmic Sperm Injection Cycle
System Organ Class/Adverse Reactions Follistim AQ Cartridge Treatment
N = 751
n* (%)
*
n = number of women with the adverse reaction
Nervous System disorders
  Headache 55 (7.3%)
Gastrointestinal disorders
  Nausea 29 (3.9%)
Reproductive system and breast disorders
  Ovarian Hyperstimulation Syndrome 48 (6.4%)
  Pelvic discomfort 62 (8.3%)
  Pelvic Pain 41 (5.5%)
General disorders and Administration site conditions
  Fatigue 17 (2.3%)

Induction of Spermatogenesis

In an open-label, non-comparative clinical trial, 49 men with hypogonadotropic hypogonadism were enrolled to received pretreatment with hCG, followed by combination therapy with hCG and Follistim for induction of spermatogenesis. Of the 49 men, 30 received weekly Follistim doses of 450 international units; 24 of these 30 men received a total of 48 weeks of treatment with Follistim. Adverse reactions occurring with an incidence of greater than 2% in the 30 men treated with Follistim are listed in Table 4.

Table 4: Common Adverse Reactions Reported At a Frequency of ≥2% in an Open-Label Clinical Trial in Men with Hypogonadotropic Hypogonadism
System Organ Class/Adverse Reactions Follistim Treatment
N=30
n (%)
Nervous system disorders
  Headache 2 (6.7)
General disorders and administration site disorders
  Injection site reaction 2 (6.7)
  Injection site pain 2 (6.7)
Skin and cutaneous tissue disorders
  Acne 2 (6.7)
  Rash 1 (3.3)
Reproductive system and breast disorders
  Gynecomastia 1 (3.3)
Neoplasms benign, malignant and unspecified
  Dermoid cyst 1 (3.3)

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Follistim and/or Follistim AQ Cartridge. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Gastrointestinal disorders

Abdominal distension, abdominal pain, constipation, diarrhea

General disorders and administration site conditions

Injection site reaction

Reproductive system and breast disorders

Breast tenderness, metrorrhagia, ovarian enlargement, vaginal hemorrhage

Skin and subcutaneous tissue disorders

Rash

Vascular disorders

Thromboembolism [see Warnings and Precautions (5.3)]

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Side 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.

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More Follistim AQ resources

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