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What the label lists and what reports show

Follitropin alfa side effects

Follitropin alfa's FDA label: “The most common adverse reactions (≥5%) in ovulation induction include: ovarian cyst, headache, abdominal pain, OHSS, nausea, flatulence, pain and intermenstrual bleeding.” FAERS holds 2,009 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is ovarian hyperstimulation syndrome (687 reports).

  • No generic listed

Check it at the source: the follitropin alfa FDA label on DailyMed (effective September 2, 2025); the FDA FAERS public dashboard.

What does the patient leaflet say about side effects?

From the patient leaflet: What are the possible side effects of GONAL-f?

GONAL-f may cause serious side effects in women and men, including: severe allergic reactions. Women or men who have used GONAL-f in the past may have a severe allergic reaction right away when they use GONAL-f again. This severe allergic reaction may lead to death. If you have any of the following symptoms of a severe allergic reaction, stop using GONAL-f and go to the nearest hospital emergency room right away: shortness of breath swelling of your face itchy, red bumps or rash on your skin (hives) lung problems. GONAL-f may cause serious lung problems including fluid in your lungs (atelectasis), trouble breathing (acute respiratory distress syndrome), and worsening of asthma. blood clots. GONAL-f may increase your chance of having blood clots in your blood vessels. […]

Source: FDA drug label, EMD Serono, Inc., effective September 2, 2025 (SPL set ae85b9c3-e7eb-4981-a5d9-346050e8f189), via openFDA; the full label on DailyMed

What does the label list?

From the label: adverse reactions

The most common adverse reactions (≥5%) in ovulation induction include: ovarian cyst, headache, abdominal pain, OHSS, nausea, flatulence, pain and intermenstrual bleeding.

Table 1: Common Adverse Reactions Reported at a Frequency of ≥ 5% in an U.S. Ovulation Induction Trial

System Organ Class/Adverse ReactionsGONAL-f N=118 total number of women treated with GONAL-f (288 treatment cycles up to 3… Body as a Whole - General
Pain6 (5.1%)
Headache12 (10.2%)
Abdominal Pain9 (7.6%)
Nausea7 (5.9%)
Flatulence7 (5.9%)
Intermenstrual Bleeding6 (5.1)
Ovarian Hyperstimulation8 (6.8%)
Ovarian Cyst17 (14.4%)

Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.

From the label: adverse reactions, continued

The following serious adverse reactions are discussed elsewhere in the labeling: Hypersensitivity Reactions and Anaphylaxis [see Warnings and Precautions (5.1) ] Ovarian Hyperstimulation Syndrome [see Warnings and Precautions (5.2) ] Pulmonary and Vascular Complication [see Warnings and Precautions (5.3) ] Ovarian Torsion [see Warnings and Precautions (5.4) ] Abnormal Ovarian Enlargement [see Warnings and Precautions (5.5) ] Multi-fetal Gestation and Birth [see Warnings and Precautions (5.6) ] Embryofetal Toxicity [see Warnings and Precautions (5.7) ] Ectopic Pregnancy [see Warnings and Precautions (5.8) ] Spontaneous Abortion [see Warnings and Precautions (5.9) ] Ovarian Neoplasms [see Warnings and Precautions (5.10) ] The most common adverse reactions (≥5%) in ovulation induction include: ovarian cyst, headache, abdominal pain, OHSS, nausea, flatulence, pain and intermenstrual bleeding. ( 6.1 ) The most common adverse reactions (≥5%) in development of multiple follicles in ART include: headache, nausea, pelvic pain and abdominal pain. ( 6.1 ) The most common adverse reactions (>5%) in hypogonadotropic hypogonadal men participating in induction of spermatogenesis include: acne, injection site pain, fatigue, gynecomastia and seborrhea.

Source: FDA drug label, EMD Serono, Inc., effective September 2, 2025 (SPL set ae85b9c3-e7eb-4981-a5d9-346050e8f189), via openFDA; the full label on DailyMed

What do FAERS reports show?

2,009 reports list follitropin alfa among the medicines taken, each a report of something that happened, not proof the medicine caused it; 30 are coded as a death and 973 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 19 reactions below, 10 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Ovarian Hyperstimulation Syndrome (named in the label)687
  • Ascites223
  • Abdominal Pain (named in the label)128
  • Abortion Spontaneous123
  • Abdominal Distension (named in the label)116
  • Nausea (named in the label)101
  • Dyspnoea (named in the label)100
  • Vomiting (named in the label)83
  • Inappropriate Schedule Of Drug Administration (a use or a product term, not a reaction)80
  • Pleural Effusion76
  • Drug Ineffective (a use or a product term, not a reaction)75
  • Off Label Use (a use or a product term, not a reaction)67
  • Drug Exposure During Pregnancy (a use or a product term, not a reaction)58
  • Headache (named in the label)51
  • Maternal Exposure During Pregnancy (a use or a product term, not a reaction)50
  • Malaise44
  • Ovarian Enlargement (named in the label)38
  • Chest Discomfort34
  • Pregnancy (a use or a product term, not a reaction)34
  • Fatigue (named in the label)33
  • Abortion Missed32
  • Ectopic Pregnancy (named in the label)31
  • Abdominal Pain Lower29
  • Syncope28
  • Caesarean Section27

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Follitropin alfa: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions