Gonadorelin — safety
Adverse events as reported, contraindications, warnings, and an explicit statement of what the safety evidence does not establish.
§4Safety
§4.1Adverse events reported in controlled trials
Table 4. Adverse events for Gonadorelin as reported in the trial safety tables the Institute holds. Percentages are of randomised participants in the stated trial and arm.
| Event | Active, % | Comparator, % | Difference, pp | Source |
|---|---|---|---|---|
| Headache | — | — | — | Reported |
| Nausea | — | — | — | Reported |
| Abdominal discomfort | — | — | — | Reported |
| Flushing | — | — | — | Reported |
| Injection-site reaction | — | — | — | Reported |
| Ovarian hyperstimulation | — | — | — | With pulsatile ovulation-induction use |
| Paradoxical axis suppression | — | — | — | The predictable consequence of continuous or frequent non-pulsatile administration, and the principal risk of uncontrolled use |
| A difference column is computed by the Institute from the two reported percentages and is not itself a published figure. Confidence intervals for adverse-event differences are not reported in the contributing trials and are not constructed here. | ||||
§4.2Contraindications
- Known hypersensitivity
- Hormone-dependent tumours for therapeutic use
§4.3Warnings and precautions
- Pattern of administration determines whether the axis is stimulated or suppressed; frequent non-pulsatile dosing produces downregulation
- Ovarian hyperstimulation with ovulation-induction use
- Diagnostic authorisations do not extend to any therapeutic use
§4.4What this section does not establish
Related assessments: tolerability of incretin receptor agonists · acute pancreatitis · the rodent thyroid C-cell signal.[1,2]
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- D’Hondt M, Bracke N, Taevernier L, Gevaert B, Verbeke F, Wynendaele E, De Spiegeleer B. Related impurities in peptide medicines. Journal of Pharmaceutical and Biomedical Analysis 2014;101:2–30. doi:10.1016/j.jpba.2014.06.012 · PMID 25044089
- Manning MC, Chou DK, Murphy BM, Payne RW, Katayama DS. Stability of protein pharmaceuticals: an update. Pharmaceutical Research 2010;27(4):544–575. doi:10.1007/s11095-009-0045-6 · PMID 20143256
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.