Skip to Content

Rybelsus Side Effects

Generic Name: semaglutide

Note: This document contains side effect information about semaglutide. Some of the dosage forms listed on this page may not apply to the brand name Rybelsus.

For the Consumer

Applies to semaglutide: subcutaneous solution

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.

Side effects requiring immediate medical attention

Along with its needed effects, semaglutide (the active ingredient contained in Rybelsus) 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

  • Gaseous abdominal pain
  • recurrent fever
  • stomach fullness
  • yellow eyes or skin

Rare

Incidence not known

  • Anxiety
  • blurred vision
  • chills
  • cold sweats
  • confusion
  • cool, pale skin
  • discouragement
  • dizziness
  • fast heartbeat
  • feeling sad or empty
  • headache
  • increased heart rate
  • increased hunger
  • irritability
  • lack of appetite
  • loss of consciousness
  • loss of interest or pleasure
  • nausea
  • nervousness
  • nightmares
  • seizures
  • shakiness
  • slurred speech
  • tiredness
  • trouble concentrating
  • trouble sleeping
  • unusual tiredness or weakness

Side effects not requiring immediate medical attention

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

Less common

Rare

  • 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
  • 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

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 20%), increased amylase (up to 13%), increased lipase (up to 22%)

Common (1% to 10%): Vomiting, diarrhea, abdominal pain, constipation, dyspepsia, eructation, flatulence, gastroesophageal reflux disease, abdominal distention

Uncommon (0.1% to 1%): Gastritis

Frequency not reported: Acute pancreatitis, chronic pancreatitis

In clinical trials, 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.

Hypersensitivity

Rare (less than 0.1%): Anaphylactic reaction

Frequency not reported: Angioedema

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

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

Uncommon (0.1% to 1%): Injection site reactions

Immunologic

Frequency not reported: Development of anti-semaglutide (the active ingredient contained in Rybelsus) 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

Cholelithiasis has been reported in 1.5% and 0.4% of patients receiving 0.5 mg and 1 mg weekly, respectively

Other

Frequency not reported: Fatigue

Fatigue was reported in greater than 0.4% of patients.

Nervous system

Common (1% to 10%): Dizziness

Uncommon (0.1% to 1%): Dysgeusia

Renal

GLP-1 Receptor Agonists:

Postmarketing reports: Acute kidney injury, worsening of chronic renal failure

Cardiovascular

A mean increase in heart rate of 2 to 3 beats per minute was reported in clinical trials.

Frequency not reported: Increased heart rate

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. "Product Information. Ozempic (1 mg dose) (semaglutide)." Novo Nordisk Pharmaceuticals Inc, Princeton, NJ.

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.

Related questions