Tirzepatide Use During Pregnancy
No, you should not take tirzepatide while pregnant—discontinue it immediately if pregnancy is confirmed or suspected. The FDA drug label explicitly states that tirzepatide should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus, and available human data are insufficient to evaluate drug-related risks 1.
Key Safety Concerns
Animal Studies Show Fetal Harm
- Pregnant rats exposed to tirzepatide during organogenesis developed fetal growth reductions, external/visceral/skeletal malformations, and developmental variations at clinically relevant exposures 1
- Pregnant rabbits experienced maternal mortality, abortion, and reduced fetal weights associated with decreased maternal food consumption at all tested doses 1
- These adverse embryo/fetal effects coincided with pharmacological effects on maternal weight and food consumption 1
Insufficient Human Data
- There are no adequate human studies to evaluate tirzepatide's risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes 1
- A recent large observational study of 938 pregnancies with type 2 diabetes compared GLP-1 receptor agonists to insulin but lacked critical information on maternal glycemic control and diabetic fetopathy, making conclusions about safety impossible 2
- Case reports and small cohort studies have not shown a pattern of congenital anomalies, but the evidence base remains extremely limited 2
Clinical Management Algorithm
If Currently Taking Tirzepatide:
- Stop tirzepatide immediately upon pregnancy confirmation or suspicion 1, 2
- Transition to insulin therapy, which is the preferred medication for treating hyperglycemia in pregnancy 3
- Insulin has established safety data and is recommended as first-line treatment for gestational diabetes and pre-existing diabetes in pregnancy 3
Contraception Requirements:
- All patients of childbearing potential must use effective contraception while taking tirzepatide to prevent unintended pregnancy 2
- For patients using oral hormonal contraceptives, switch to a non-oral method or add barrier contraception for 4 weeks after initiation and after each dose escalation, as tirzepatide delays gastric emptying and may affect oral contraceptive absorption 1
Diabetes Management in Pregnancy
Preferred Treatment Options:
- Insulin is the gold standard for treating hyperglycemia during pregnancy, with established safety and efficacy 3
- Metformin and glyburide should not be used as first-line agents as both cross the placenta 3
- Other oral and non-insulin injectable glucose-lowering medications (including GLP-1 receptor agonists like tirzepatide) lack long-term safety data 3
Glycemic Targets:
- Target A1C <6% (42 mmol/mol) if achievable without significant hypoglycemia 3
- CGM time-in-range goal >70% (63-140 mg/dL) for type 1 diabetes 3
Critical Pitfalls to Avoid
Do not continue tirzepatide based on limited reassuring human data—the absence of detected harm in small studies does not equal proof of safety, and animal studies clearly demonstrate fetal risks at clinically relevant exposures 1, 2.
Do not delay switching to insulin—poorly controlled diabetes in pregnancy increases maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications, while increasing fetal risk for major birth defects, stillbirth, and macrosomia 1.
Do not assume weight loss benefits outweigh fetal risks—the pharmacologically-mediated reductions in maternal body weight and food consumption that occur with tirzepatide are associated with fetal growth reductions and malformations in animal studies 1.
Lactation Considerations
- No data exist on the presence of tirzepatide in human or animal milk, effects on breastfed infants, or effects on milk production 1
- The decision to breastfeed while taking tirzepatide requires weighing unknown risks against benefits, though this scenario should be avoided by discontinuing tirzepatide before or during pregnancy 1