What the label lists and what reports show
Follitropin side effects
Follitropin's FDA label: “The most common adverse reactions (≥2%) in women undergoing ovulation induction are ovarian hyperstimulation syndrome, ovarian cyst, abdominal discomfort, abdominal pain and lower abdominal pain.” FAERS holds 954 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 headache (97 reports).
- No generic listed
Check it at the source: the follitropin FDA label on DailyMed (effective May 26, 2026); 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 FOLLISTIM AQ Cartridge?FOLLISTIM AQ Cartridge may cause serious side effects in women, including: Ovarian enlargement. FOLLISTIM AQ may cause your ovaries to be abnormally large. Symptoms of large ovaries include bloating or pain in your lower stomach (pelvic) area. Ovarian hyperstimulation syndrome (OHSS). OHSS is a serious side effect that can happen when the ovaries produce too many eggs (overstimulated). In rare cases it has caused death. OHSS causes fluid to build up suddenly in your stomach and chest areas and can cause blood clots to form. OHSS may also happen after you stop using FOLLISTIM AQ Cartridge. Stop using FOLLISTIM AQ Cartridge and call your healthcare provider right away if you have symptoms of OHSS, including: severe lower stomach (pelvic) area pain nausea vomiting weight gain stomach (abdomen) pain bloating diarrhea trouble breathing decreased urine output Lung problems. […]
Source: FDA drug label, Organon LLC, effective May 26, 2026 (SPL set 48489027-e52b-4b10-ae74-4ba03839150c), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥2%) in women undergoing ovulation induction are ovarian hyperstimulation syndrome, ovarian cyst, abdominal discomfort, abdominal pain and lower abdominal pain.
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) |
| Injection site reaction | 2 (6.7) |
| Injection site pain | 2 (6.7) |
| Acne | 2 (6.7) |
| Rash | 1 (3.3) |
| Gynecomastia | 1 (3.3) |
| Dermoid cyst | 1 (3.3) |
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, continuedThe following serious adverse reactions are discussed elsewhere in the labeling: Abnormal Ovarian Enlargement [see Warnings and Precautions (5.1) ] Ovarian Hyperstimulation Syndrome [see Warnings and Precautions (5.2) ] Atelectasis [see Warnings and Precautions (5.3) ] Thromboembolism [see Warnings and Precautions (5.3) ] Ovarian Torsion [see Warnings and Precautions (5.4) ] Multi-fetal Gestation and Birth [see Warnings and Precautions (5.5) ] Congenital Anomalies [see Warnings and Precautions (5.6) ] Ectopic Pregnancy [see Warnings and Precautions (5.7) ] Spontaneous Abortion [see Warnings and Precautions (5.8) ] Ovarian Neoplasms [see Warnings and Precautions (5.9) ] The most common adverse reactions (≥2%) in women undergoing ovulation induction are ovarian hyperstimulation syndrome, ovarian cyst, abdominal discomfort, abdominal pain and lower abdominal pain. ( 6.1 ) The most common adverse reactions (≥2%) in women undergoing controlled ovarian stimulation as part of an IVF or ICSI cycle are pelvic discomfort, headache, ovarian hyperstimulation syndrome, pelvic pain, nausea and fatigue. ( 6.1 ) The most common (≥2%) adverse reactions in men undergoing induction of spermatogenesis are headache, acne, injection site reaction, injection site pain, gynecomastia, rash and dermoid cyst.
Source: FDA drug label, Organon LLC, effective May 26, 2026 (SPL set 48489027-e52b-4b10-ae74-4ba03839150c), via openFDA; the full label on DailyMed
What do FAERS reports show?
954 reports list follitropin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2 are coded as a death and 64 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 18 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
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Follitropin: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions