From the FDA label & pivotal trialsReviewed 2026-05-31

Mounjaro Side Effects: What to Expect

Every reaction the tirzepatide trial program recorded, alongside the boxed warning and the Section 5 risks its FDA label carries.

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Most Common Mounjaro Side Effects

Every reaction the Mounjaro FDA label records, showing how often it appeared among tirzepatide-treated patients and how often it appeared on placebo. The figures are taken from the label's Section 6, DailyMed SetIDd2d7da5d-ad07-4228-955f-cf7e355c8cc0.

Adverse reactionIncidence (Mounjaro vs placebo)
Nausea12–18% (placebo 4%)
Diarrhea12–17% (placebo 9%)
Decreased appetite5–11% (placebo 1%)
Vomiting5–9% (placebo 2%)
Constipation6–7% (placebo 1%)
Dyspepsia5–8% (placebo 3%)
Abdominal pain5–6% (placebo 4%)

Source: Mounjaro FDA prescribing information via DailyMed (SetID d2d7da5d-ad07-4228-955f-cf7e355c8cc0), Section 6 Adverse Reactions, read on 2026-05-31. Treat this as a summary — the full label is the document, and a prescriber is the person to discuss it with.

Boxed Warning — Thyroid C-Cell Tumors

Tirzepatide causes thyroid C-cell tumors in rats. It is unknown whether MOUNJARO causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined. MOUNJARO is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Quoted word for word from the Mounjaro FDA label (DailyMed SetID d2d7da5d-ad07-4228-955f-cf7e355c8cc0). Nothing the FDA issues carries more weight than a boxed warning. Your own history and your family's both need to be on the table before you start Mounjaro, and that means talking to a licensed prescriber.

Serious Warnings & Precautions

Past the everyday reactions above, Section 5 of the Mounjaro label sets out these serious risks. They arrive far less often, and some of them need care the same day — which is why the symptoms are worth knowing and when to seek care.

  • Risk of thyroid C-cell tumors
  • Acute pancreatitis
  • Hypoglycemia with concomitant use of insulin secretagogues or insulin
  • Hypersensitivity reactions
  • Acute kidney injury due to volume depletion
  • Severe gastrointestinal adverse reactions
  • Diabetic retinopathy complications
  • Acute gallbladder disease
  • Pulmonary aspiration during general anesthesia or deep sedation

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What to do about each symptom, and the evidence underneath it, is covered here:

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Frequently Asked Questions