Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Follitropin beta
Drug ID BADD_D00955
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 G03GA06
DrugBank ID DB00066
KEGG ID D04430
MeSH ID C571802
PubChem ID Not Available
TTD Drug ID Not Available
NDC Product Code 12860-0750; 12860-0751
UNII QR8T22JM5W
Synonyms follitropin beta | follitropin-beta | Follistim | Puregon | Org 32489 | Org-32489
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 pain07.01.05.002--
Abortion spontaneous18.01.04.001--Not Available
Alopecia23.02.02.001--
Arthralgia15.01.02.001--
Breast tenderness21.05.05.004--Not Available
Chills15.05.03.016; 08.01.09.001--
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
Dry skin23.03.03.001--
Dyspnoea02.11.05.003; 22.02.01.004--
Ectopic pregnancy18.02.02.002--Not Available
Headache17.14.01.001--
Influenza like illness08.01.03.010--
Injection site pain12.07.03.011; 08.02.03.010--Not Available
Malaise08.01.01.003--
Musculoskeletal pain15.03.04.007--
Nausea07.01.07.001--
Ovarian enlargement21.11.02.001--Not Available
Ovarian hyperstimulation syndrome05.05.01.013; 21.11.02.007--Not Available
Pyrexia08.05.02.003--
Rash23.03.13.001--Not Available
Skin disorder23.03.03.007--Not Available
Tachycardia02.03.02.007--Not Available
Tachypnoea22.02.01.014--Not Available
Urticaria23.04.02.001; 10.01.06.001--
Vaginal haemorrhage24.07.03.005; 21.08.01.001--
Pulmonary vascular disorder24.03.08.003; 22.06.03.002--Not Available
Ovarian neoplasm21.11.01.005; 16.12.06.001--Not Available
Adnexal torsion21.11.02.012--Not Available
Haemoperitoneum24.07.02.065; 12.01.17.007; 07.07.02.007--Not Available
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