Tirzepatide Side Effects
Medically reviewed by Drugs.com. Last updated on Dec 24, 2022.
Applies to tirzepatide: subcutaneous solution.
Warning
Subcutaneous route (Solution)
Risk of Thyroid C-Cell TumorsIn both male and female rats, tirzepatide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether tirzepatide causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of tirzepatide induced rodent thyroid C-cell tumors has not been determined. Tirzepatide is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC with the use of tirzepatide and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with tirzepatide.
Serious side effects of Tirzepatide
Along with its needed effects, tirzepatide may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking tirzepatide:
More common
- Stomach pain
Less common
- Difficulty in breathing or swallowing
- fast heartbeat
- gaseous stomach pain
- heartburn
- recurrent fever
- skin itching, rash, or redness
- stomach fullness
- swelling of the face, throat, or tongue
- vomiting
- yellow eyes or skin
Incidence not known
- Anxiety
- bloating
- blurred vision
- change in vision
- chest tightness
- chills
- cold sweats
- coma
- confusion
- constipation
- cool, pale skin
- cough
- darkened urine
- depression
- dizziness
- fast heartbeat
- fever
- increased hunger
- indigestion
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- loss of appetite
- nausea
- nervousness
- nightmares
- pains in the stomach, side, or abdomen, possibly radiating to the back
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- seizures
- shakiness
- slurred speech
- unusual tiredness or weakness
Other side effects of Tirzepatide
Some side effects of tirzepatide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Acid or sour stomach
- belching
- constipation
- diarrhea
- stomach discomfort or upset
Less common
- Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
For Healthcare Professionals
Applies to tirzepatide: subcutaneous solution.
General
The most common adverse reactions reported in 5% of patients or greater treated with this drug included nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia, and abdominal pain.[Ref]
Cardiovascular
In pooled placebo-controlled trials, treatment with this drug resulted in a mean increase in heart rate of 2 to 4 beats per minute compared to a mean increase of 1 beat per minute in placebo-treated patients. Episodes of sinus tachycardia (associated with a concomitant increase from baseline in heart rate of at least 15 beats per minute) were reported in up to 23% of patients. The clinical relevance of increased heart rate was uncertain.
Very common (10% or more): Sinus tachycardia (up to 23%)
Frequency not reported: Increased heart rate
Gastrointestinal
In pooled placebo-controlled trials, treatment with this drug resulted in mean increases from baseline in serum pancreatic amylase levels of up to 38% and serum lipase levels of up to 42%; placebo-treated patients had a mean increase from baseline in pancreatic amylase of 4% and no changes were observed in lipase. The clinical significance of elevations in lipase or amylase with this drug was unknown without other signs/symptoms of pancreatitis.
Very common (10% or more): Nausea (up to 18%), diarrhea (up to 17%)
Common (1% to 10%): Vomiting, constipation, dyspepsia, abdominal pain, eructation, flatulence, gastroesophageal reflux disease, abdominal distension
Uncommon (0.1% to 1%): Cholelithiasis, acute pancreatitis, increased serum pancreatic amylase levels, increased serum lipase levels, acute gallbladder disease (including cholelithiasis, biliary colic and cholecystectomy)
Postmarketing reports: Ileus
Hepatic
Uncommon (0.1% to 1%): Acute gallbladder disease (cholelithiasis, biliary colic, cholecystectomy)
Hypersensitivity
Common (1% to 10%): Hypersensitivity reactions (e.g., urticaria, eczema)
Postmarketing reports: Anaphylaxis, angioedema
Immunologic
Very common (10% or more): Anti-drug antibodies (up to 51%)
Common (1% to 10%): Neutralizing antibodies
Local
Common (1% to 10%): Injection site reactions
Metabolic
Very common (10% or more): Hypoglycemia (up to 19%), decreased appetite (up to 11%)
Common (1% to 10%): Hyperglycemia
Hypoglycemia (glucose level less than 54 mg/dL) occurred more frequently when this drug was used in combination with a sulfonylurea (up to 13% of patients in a clinical trial); severe hypoglycemia occurred in up to 6% of patients. Hyperglycemia occurred more frequently in the placebo group versus in patients treated with this drug.
Other
Common (1% to 10%): Fatigue, including asthenia, malaise, lethargy
Uncommon (0.1% to 1%): Blood calcitonin increased
Renal
Postmarketing reports (in other GLP-1 receptor agonists): Acute kidney injury, worsening of chronic renal failure
Respiratory
Very common (10% or more): Nasopharyngitis (10.5%)
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More about tirzepatide
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References
1. Product Information. Mounjaro (tirzepatide). Eli Lilly and Company Ltd. 2023.
2. Product Information. Mounjaro (tirzepatide). Lilly, Eli and Company. 2023.
3. Product Information. Mounjaro (tirzepatide). Eli Lilly Australia Pty Ltd. 2023.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.