Semaglutide Side Effects
Medically reviewed by drugclasses.com. Last updated on Nov 21, 2023.
Applies to semaglutide: subcutaneous solution. Other dosage forms:
Warning
Subcutaneous route (Solution)
Warning: Risk of Thyroid C-Cell TumorsIn rodents, semaglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether semaglutide causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as 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 for MTC with the use of semaglutide and inform them of symptoms of thyroid tumors (eg, 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 semaglutide.
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:
Less common
- Belching
- bloated, full feeling
- excess air or gas in the stomach or intestines
- gaseous stomach pain
- heartburn
- passing gas
- recurrent fever
- stomach discomfort, fullness, or pain
- yellow eyes or skin
Rare
- Burning feeling in the chest or stomach
- indigestion
- stomach upset
- tenderness in the stomach area
Incidence not known
- Anxiety
- blurred vision
- chest tightness
- chills
- cold sweats
- confusion
- cool, pale skin
- cough
- darkened urine
- difficulty swallowing
- discouragement
- dizziness
- fast heartbeat
- feeling sad or empty
- headache
- hives, itching
- increased heart rate
- increased hunger
- irritability
- lack of appetite
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- loss of consciousness
- loss of interest or pleasure
- nausea
- nightmares
- pains in stomach, side, or abdomen, possibly radiating to the back
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- redness of the skin
- seizures
- shakiness
- skin rash
- slurred speech
- tiredness
- trouble breathing
- trouble concentrating
- trouble sleeping
- unusual tiredness or weakness
- vomiting
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:
More common
- Diarrhea
Less common
- Constipation
- hair loss
Rare
- Bleeding, blistering, burning, coldness, discoloration of the 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
- change in taste
- loss of taste
For Healthcare Professionals
Applies to semaglutide: oral tablet, subcutaneous solution.
General
The most commonly reported adverse reactions have included nausea, vomiting, diarrhea, abdominal pain, and constipation.[Ref]
Oncologic
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.
GLP- 1 Receptor Agonist:
Postmarketing reports: Medullary thyroid cancer
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
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]).
Common (1% to 10%): Diabetic retinopathy complications
Metabolic
In the weight loss clinical trials, patients without type 2 diabetes experienced episodes of hypoglycemia.
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
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
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.
Common (1% to 10%): Hypotension, orthostatic hypotension
Uncommon (0.1% to 1%): Syncope
Frequency not reported: Increased heart rate
Dermatologic
Common (1% to 10%): Hair loss
Frequently asked questions
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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
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.