Tirzepatide Side Effects
Medically reviewed by Drugs.com. Last updated on Dec 16, 2024.
Applies to tirzepatide: subcutaneous solution.
Important warnings
This medicine can cause some serious health issues
Subcutaneous route (solution)
Risk of Thyroid C-Cell Tumors. In 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.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
Mounjaro®: Tell your doctor if you are pregnant or planning to become pregnant. Do not use this medicine for at least 2 months before you plan to become pregnant.
Zepbound™: Using this medicine while you are pregnant can harm your unborn baby. If you think you have become pregnant while using this medicine, tell your doctor right away.
If you are using birth control pills, your doctor may recommend another type of birth control for 4 weeks after you start using this medicine and after each increase in your dose.
It is very important to carefully follow any instructions from your health care team about:
- Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.
- Other medicines—Do not take other medicines during the time you are using tirzepatide unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.
- Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, diabetic patients may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur during pregnancy in patients with diabetes.
- Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.
In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines.
This medicine may increase the risk of having thyroid tumors. Tell your doctor right away if you have a lump or swelling in your neck or throat, trouble swallowing or breathing, or if your voice gets hoarse.
Pancreatitis (swelling of the pancreas) may occur while you are using this medicine. Check with your doctor right away if you have sudden and sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.
Check with your doctor right away if you have gaseous stomach pain, indigestion, recurrent fever, severe nausea or vomiting, stomach fullness, or yellow eyes or skin. These may be symptoms of gallbladder problems (eg, cholelithiasis, cholecystitis).
This medicine may cause diabetic retinopathy. Check with your doctor if you have blurred vision or any other changes in vision.
This medicine does not cause hypoglycemia (low blood sugar). However, low blood sugar can occur when you use tirzepatide with other medicines, including insulin or sulfonylureas, that can lower blood sugar. Low blood sugar also can occur if you delay or miss a meal or snack, exercise more than usual, drink alcohol, or cannot eat because of nausea or vomiting.
- Symptoms of low blood sugar include anxiety, behavior change similar to being drunk, blurred vision, cold sweats, confusion, cool, pale skin, difficulty with thinking, drowsiness, excessive hunger, fast heartbeat, headache (continuing), nausea, nervousness, nightmares, restless sleep, shakiness, slurred speech, or unusual tiredness or weakness.
- If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes, or drink fruit juice, non-diet soft drink, or sugar dissolved in water to relieve the symptoms. Also, check your blood for low blood sugar. Glucagon is used in emergency situations when severe symptoms including seizures or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. Members of your family should also know how to use it.
This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, mouth, or throat while you are using this medicine.
This medicine may cause acute kidney injury. Check with your doctor right away if you have a bloody urine, decreased urine output, muscle twitching, nausea, rapid weight gain, seizures, stupor, swelling of the face, ankles, or hands, or unusual tiredness or weakness.
This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Also tell your doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you or your caregiver notice any of these side effects, tell your doctor right away.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
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 side effects
- stomach pain
Less common side effects
- 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
- changes in behavior
- 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
- thoughts of harming oneself
- 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 side effects
- acid or sour stomach
- belching
- constipation
- diarrhea
- stomach discomfort or upset
Less common side effects
- 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 adverse events
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
- Very common (10% or more): Sinus tachycardia (up to 23%)
- Frequency not reported: Increased heart rate
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.
Gastrointestinal
- 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
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.
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%)
See also:
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Wegovy
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Mounjaro
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Zepbound
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References
1. (2023) "Product Information. Mounjaro (tirzepatide)." Eli Lilly and Company Ltd
2. (2023) "Product Information. Mounjaro (tirzepatide)." Lilly, Eli and Company
3. (2023) "Product Information. Mounjaro (tirzepatide)." Eli Lilly Australia Pty Ltd
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Further information
Tirzepatide side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.