Semaglutide Side Effects
Medically reviewed by Drugs.com. Last updated on Nov 21, 2023.
Applies to semaglutide: oral tablet.
Other dosage forms:
Important warnings
This medicine can cause some serious health issues
Oral route (tablet)
Warning: Risk of Thyroid C-Cell Tumors. In rodents, semaglutide causes thyroid C-cell tumors.
It is unknown whether semaglutide causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as the human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined.Semaglutide 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 of MTC and symptoms of thyroid tumors
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.
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.
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 semaglutide 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 severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.
Check with your doctor right away if you have blurred vision or any other changes in vision. These may be symptoms of diabetic retinopathy.
This medicine does not cause hypoglycemia (low blood sugar). However, low blood sugar can occur when you use semaglutide with other medicines, such as 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 such as 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 kidney problems, including 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 serious allergic reactions, including anaphylaxis and angioedema. These 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.
Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your antidiabetic medicine, overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual.
- Symptoms of high blood sugar include blurred vision, drowsiness, dry mouth, flushed, dry skin, fruit-like breath odor, increased urination (frequency and amount), ketones in the urine, loss of appetite, stomachache, nausea or vomiting, tiredness, trouble breathing (rapid and deep), unconsciousness, or unusual thirst.
- If symptoms of high blood sugar occur, check your blood sugar level and then call your doctor for instructions.
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 semaglutide
Along with its needed effects, semaglutide 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 semaglutide:
More common side effects
- anxiety
- bloating
- blurred vision
- chills
- cold sweats
- confusion
- constipation
- cool, pale skin
- cough
- darkened urine
- depression
- diarrhea
- difficulty swallowing
- dizziness
- fast heartbeat
- fever
- headache
- 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
- nightmare
- pain in the stomach, side, or abdomen, possibly radiating to the back
- seizures
- skin rash
- slurred speech
- tightness in the chest
- trouble breathing
- unusual tiredness or weakness
- vomiting
- yellow eyes or skin
Other side effects of semaglutide
Some side effects of semaglutide 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:
Less common side effects
- acid or sour stomach
- belching
- excess air or gas in stomach
- feeling pressure in the stomach
- heartburn
- passing gas
- stomach discomfort, swelling, tenderness, or upset
For healthcare professionals
Applies to semaglutide: oral tablet, subcutaneous solution.
General adverse events
The most commonly reported adverse reactions have included nausea, vomiting, diarrhea, abdominal pain, and constipation.[Ref]
Oncologic
GLP- 1 Receptor Agonist:
- Postmarketing reports: Medullary thyroid cancer
Cases of Medullary thyroid cancer (MTC) have been reported in patients treated with liraglutide in the postmarketing period; the data in these reports is insufficient to establish or exclude a causal relationship between MTC and GLP-1 receptor agonist use in humans.
Gastrointestinal
- Very common (10% or more): Nausea (up to 44%), increased amylase (up to 13%), increased lipase (up to 22%), diarrhea (up to 30%), vomiting (up to 24%), constipation (up to 24%), abdominal pain (up to 20%),
- Common (1% to 10%): Dyspepsia, eructation, flatulence, gastroesophageal reflux disease, abdominal distention, gastroenteritis, gastroesophageal reflux disease, gastritis, gastroenteritis (viral)
- Uncommon (0.1% to 1%): Appendicitis
- Frequency not reported: Acute and necrotizing pancreatitis, chronic pancreatitis
In clinical trials for type 2 diabetes, acute pancreatitis was confirmed by adjudication in 7 (0.3 cases per 100 patient years) and 8 patients (0.27 per 100 patient years) in 2 separate trials (compared to 3 and 10 placebo treated patients, respectively). One case of chronic pancreatitis was confirmed. In clinical trials for weight loss, 4 cases of acute pancreatitis were confirmed by adjudication (vs 1 placebo case). In weight loss trials, nausea, diarrhea, vomiting, constipation, and abdominal pain were reported more frequently than in clinical trials for type 2 diabetes.
Hypersensitivity
- Rare (less than 0.1%): Anaphylactic reaction
- Frequency not reported: Angioedema
- Postmarketing reports: Ananaphylaxis, rash, urticaria
Ocular
- Common (1% to 10%): Diabetic retinopathy complications
In a 2-year trial among patients with type 2 diabetes and high cardiovascular risk, patients treated with this drug experienced a great incidence of diabetic retinopathy complications (3% vs 1.8%). The absolute risk was greater in patients with a history of diabetic retinopathy at baseline (8.2%[drug] vs 5.2%[placebo]) than those without (0.7%[drug] vs 0.4%[placebo]).
Metabolic
- Very common (10% or more): Hypoglycemia (up to 30% when used in combination with basal insulin)
- Common (1% to 10%): Hypoglycemia, decreased appetite, weight loss
In the weight loss clinical trials, patients without type 2 diabetes experienced episodes of hypoglycemia.
Local
- Common (1% to 10%): Injection site reactions
Immunologic
- Frequency not reported: Development of anti-semaglutide antibodies
As with other protein and peptide pharmaceuticals, patients receiving this drug have developed anti-semaglutide antibodies. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay, as well as other factor in handling of the sample. For these reasons, the incidence of antibodies cannot be directly compared with other products. Anti-drug antibodies to semaglutide have been reported in up to 1% of patients during clinical trials.
Hepatic
- Common (1% to 10%): Cholelithiasis
- Uncommon (0.1% to 1%): Cholecystitis
- Frequency not reported: Acute gallbladder disease
Cholelithiasis has been reported in 1.5% and 0.4% of patients receiving 0.5 mg and 1 mg weekly, respectively.
Other
- Very common (10% or more): Fatigue (up to 11%)
Fatigue was reported in greater than 0.4% of patients.
Nervous system
- Very common (10% or more): Headache (up to 14%)
- Common (1% to 10%): Dizziness
- Uncommon (0.1% to 1%): Dysgeusia
Renal
- Postmarketing reports: Acute kidney injury, worsening of chronic renal failure
Cardiovascular
- Common (1% to 10%): Hypotension, orthostatic hypotension
- Uncommon (0.1% to 1%): Syncope
- Frequency not reported: Increased heart rate
A mean increase in heart rate of 2 to 3 beats per minute (bpm) was reported in clinical trials for type 2 diabetes. In weight loss clinical trials, a mean increase in resting heart rate of 1 to 4 bpm was observed. Maximal changes from baseline at any visit of 10 to 19 bpm (41% vs 34% placebo) and 20 bpm (26% vs 16% placebo) were recorded. In weight loss clinical trials, Hypotension and orthostatic hypotension were more frequently seen in patients on concomitant antihypertensive therapy. Some reactions were related to gastrointestinal reactions and associated volume loss.
Dermatologic
- Common (1% to 10%): Hair loss
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References
1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
2. (2022) "Product Information. Ozempic (1 mg dose) (semaglutide)." Novo Nordisk Pharmaceuticals Inc
3. (2021) "Product Information. Rybelsus (semaglutide)." Novo Nordisk Pharmaceuticals Inc
4. (2021) "Product Information. Wegovy (0.25 mg dose) (semaglutide)." Novo Nordisk Pharmaceuticals Inc
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Further information
Semaglutide 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.