Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Follitropin alfa
Drug ID BADD_D00954
Description Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indications and Usage In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Marketing Status approved
ATC Code G03GA05
DrugBank ID DB00066
KEGG ID D04429
MeSH ID C571801
PubChem ID Not Available
TTD Drug ID Not Available
NDC Product Code 50090-6049; 44087-9005; 44087-9070; 44087-9030
UNII VV3HN9ZPB5
Synonyms follitropin alfa | Gonal F | Gonal-F
Chemical Information
Molecular Formula Not Available
CAS Registry Number 146479-72-3
SMILES Not Available
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.002--
Abortion spontaneous18.01.04.001--Not Available
Acne23.02.01.001--Not Available
Anaphylactoid reaction24.06.03.007; 10.01.07.003--Not Available
Application site oedema12.07.01.020; 08.02.01.020--Not Available
Asthma22.03.01.002; 10.01.03.010--Not Available
Back pain15.03.04.005--
Breast pain21.05.05.003--
Constipation07.02.02.001--
Cough22.02.03.001--
Cystitis20.03.02.002; 11.01.14.001--
Diarrhoea07.02.01.001--
Dizziness17.02.05.003; 02.11.04.006; 24.06.02.007--
Dyspepsia07.01.02.001--
Ectopic pregnancy18.02.02.002--Not Available
Flatulence07.01.04.002--
Headache17.14.01.001--
Hypersensitivity10.01.03.003--
Injection site bruising08.02.03.042; 24.07.06.017; 23.03.11.015; 12.07.03.042--Not Available
Injection site inflammation12.07.03.009; 08.02.03.008--Not Available
Injection site pain12.07.03.011; 08.02.03.010--Not Available
Injection site reaction08.02.03.014; 12.07.03.015--
Malaise08.01.01.003--
Migraine24.03.05.003; 17.14.02.001--Not Available
Mouth ulceration07.05.06.004--Not Available
Multiple congenital abnormalities03.02.01.003--Not Available
Mycoplasmal postpartum fever11.10.01.001; 21.14.04.002--Not Available
Nausea07.01.07.001--
Ovarian cyst21.11.01.002; 16.04.03.001--Not Available
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