Contraindications to Ozempic (Semaglutide)
Absolute Contraindications
Ozempic is absolutely contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). 1
- This carries an FDA Black Box Warning due to dose-dependent thyroid C-cell tumors observed in rodent studies at clinically relevant exposures 2, 1
- While human relevance remains uncertain, the FDA mandates this contraindication given the potential severity of MTC 1
- Counsel patients about thyroid tumor symptoms including neck mass, dysphagia, dyspnea, and persistent hoarseness 1
- Routine serum calcitonin monitoring or thyroid ultrasound is of uncertain value for early MTC detection 1
Pregnancy and breastfeeding are absolute contraindications to semaglutide use. 2
- Safety has not been established in these populations 2
- Discontinue semaglutide if pregnancy is planned or occurs 2
Strong Relative Contraindications (Avoid Use)
Do not use Ozempic in patients with clinically meaningful gastroparesis. 2
- Semaglutide delays gastric emptying and will worsen existing gastroparesis symptoms 2
- Severe gastroparesis patients may experience significantly worsened symptoms 2
Avoid in patients with active or suspected pancreatitis. 1
- Ozempic has not been studied in patients with a history of pancreatitis 1
- Consider alternative antidiabetic therapies in patients with prior pancreatitis 1
- Acute pancreatitis has been reported in clinical trials, though causality remains unestablished 2
Important Cautions Requiring Close Monitoring
Diabetic Retinopathy
- Monitor patients with existing diabetic retinopathy closely for progression. 2
- Increased risk of diabetic retinopathy complications has been observed 2
- Particularly important in patients also treated with insulin due to rapid glucose lowering 3
Renal Impairment
- Semaglutide can be used with caution in severe renal impairment or ESRD, unlike exenatide which is contraindicated when eGFR <30 mL/min/1.73 m². 2
- Monitor renal function closely, especially during initiation or dose escalation 2
- Risk of acute kidney injury from dehydration secondary to severe gastrointestinal effects 2
- Patients with pre-existing kidney disease require careful monitoring due to increased gastrointestinal side effects 2
Gallbladder Disease
- Increased risk of cholelithiasis and cholecystitis requires monitoring. 2
- Monitor for gallbladder disease symptoms throughout treatment 2
Hypoglycemia Risk
- Risk of hypoglycemia increases when semaglutide is combined with insulin or insulin secretagogues (sulfonylureas, glinides). 2, 1
- Dose reduction of insulin or secretagogues is recommended when initiating semaglutide 2
- Semaglutide alone carries very low intrinsic hypoglycemia risk due to glucose-dependent insulin secretion 2
Oral Contraceptive Interactions
- For patients using oral hormonal contraceptives, switch to non-oral contraception or add barrier method for 4 weeks after initiation and after each dose escalation. 2
- Delayed gastric emptying may reduce absorption and efficacy of oral contraceptives 2
Additional Clinical Considerations
Not a Substitute for Insulin
- Ozempic is not indicated for type 1 diabetes mellitus or diabetic ketoacidosis. 1
- It would not be effective in these settings 1
Medication Absorption
- Semaglutide may delay absorption of concomitantly administered oral medications, particularly those with narrow therapeutic index like warfarin 2
- Consider timing of other oral medications relative to semaglutide administration 2