Saxenda Side effects

Rating: 5 - 4 review(s)
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How do you administer this medicine?

What are the possible side effects of Saxenda?

Get emergency medical help if you have signs of an allergic reaction to Saxenda: hives; fast heartbeats; dizziness; trouble breathing or swallowing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • racing or pounding heartbeats;

  • sudden changes in mood or behavior, suicidal thoughts;

  • severe ongoing nausea, vomiting, or diarrhea;

  • signs of a thyroid tumor - swelling or a lump in your neck, trouble swallowing, a hoarse voice, feeling short of breath;

  • gallbladder problems - fever, upper stomach pain, clay-colored stools, jaundice (yellowing of your skin or eyes);

  • symptoms of pancreatitis - severe pain in your upper stomach spreading to your back, nausea with or without vomiting, fast heart rate;

  • severely low blood sugar - extreme weakness, confusion, tremors, sweating, fast heart rate, trouble speaking, nausea, vomiting, rapid breathing, fainting, and seizure (convulsions); or

  • kidney problems - little or no urination; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath.

Common Saxenda side effects may include:

  • low blood sugar;

  • nausea (especially when you start using Saxenda), vomiting, stomach pain;

  • upset stomach, loss of appetite;

  • headache, dizziness, tiredness; or

  • diarrhea, constipation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects of Saxenda in details

A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
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Summary of the Safety Profile: In five large long-term clinical trials over 2,500 patients have received treatment with Saxenda alone or in combination with metformin, a sulfonylurea (with or without metformin) or metformin plus rosiglitazone.

The most frequently reported adverse reactions during clinical trials were gastrointestinal disorders: Nausea and diarrhea were very common, whereas vomiting, constipation, abdominal pain and dyspepsia were common. At the beginning of the therapy, these gastrointestinal adverse reactions may occur more frequently. These reactions usually diminish within a few days or weeks on continued treatment. Headache and nasopharyngitis were also common.

Furthermore, hypoglycemia was common and very common when Saxenda is used in combination with a sulfonylurea. Major hypoglycemia has primarily been observed when combined with a sulfonylurea.

Tabulated List of Adverse Reactions: Table 3 lists adverse reactions reported in long term phase 3 controlled trials and spontaneous (postmarketing) reports. Frequencies for related spontaneous reports (postmarketing) have been calculated based on their incidence in phase 3 clinical trials.

Frequencies are defined as: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Description of Selected Adverse Reactions: In a clinical trial with Saxenda as monotherapy, rates of hypoglycemia reported with Saxenda were lower than rates reported for patients treated with active comparator (glimepiride). The most frequently reported adverse reactions were gastrointestinal disorders, infections and infestations.

Hypoglycemia: Most episodes of confirmed hypoglycemia in clinical trials were minor. No episodes of major hypoglycemia were observed in the trial with Saxenda used as monotherapy. Major hypoglycemia may occur uncommonly and has primarily been observed when Saxenda is combined with a sulfonylurea (0.02 events/patient year). Very few episodes (0.001 events/patient year) were observed with administration of Saxenda in combination with oral antidiabetics other than sulfonylureas. The risk of hypoglycemia is low with combined use of basal insulin and Saxenda (1.0 events per patient year, see

Pharmacology: Pharmacodynamic under Actions).

Gastrointestinal Adverse Reactions: When combining Saxenda with metformin, 20.7% of patients reported at least one episode of nausea, and 12.6% of patients reported at least one episode of diarrhea. When combining Saxenda with a sulfonylurea, 9.1% of patients reported at least one episode of nausea and 7.9% of patients reported at least one episode of diarrhea. Most episodes were mild to moderate and occurred in a dose-dependent fashion. With continued therapy, the frequency and severity decreased in most patients who initially experienced nausea.

In monotherapy, patients treated with both doses of Saxenda reported a greater occurrence of nausea in the initial weeks of therapy (14%), compared with glimepiride (3%).

The proportion of Saxenda - treated patients with nausea declined over time and after 16 weeks the proportion was similar to glimepiride-treated patients.

Patients >70 years may experience more gastrointestinal effects when treated with Saxenda. Patients with mild and moderate renal impairment (creatinine clearance 60-90 mL/min and 30-59 mL/min, respectively) may experience more gastrointestinal effects when treated with Saxenda.

Withdrawal: The incidence of withdrawal due to adverse reactions was 7.8% for Saxenda-treated patients and 3.4% for comparator-treated patients in the long-term controlled trials (26 weeks or longer). The most frequent adverse reactions leading to withdrawal for Saxenda-treated patients were nausea (2.8% of patients) and vomiting (1.5%).

Injection Site Reactions: Injection site reactions have been reported in approximately 2% of patients receiving Saxenda in long-term (26 weeks or longer) controlled trials. These reactions have usually been mild.

Pancreatitis: Few cases (<0.2%) of acute pancreatitis have been reported during long-term clinical trials with Saxenda. Pancreatitis was also reported post-marketing.

Allergic Reactions: Allergic reactions including urticaria, rash and pruritus have been reported from marketed use of Saxenda.

Few cases of anaphylactic reactions with additional symptoms such as hypotension, palpitations, dyspnea and edema have been reported with marketed use of Saxenda. Few cases (0.05%) of angioedema have been reported during all long-term clinical trials with Saxenda.

Reporting of Suspected Adverse Reactions: Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.

What is the most important information I should know about Saxenda?

  • Follow the diet and exercise program given to you by your health care provider.
  • Do NOT take more than the recommended dose without checking with your doctor.
  • Tell your doctor or dentist that you take Saxenda before you receive any medical or dental care, emergency care, or surgery.
  • Check with your doctor before you drink alcohol while taking Saxenda.
  • Diabetes patients: Check your blood sugar levels as directed by your doctor. If they are often higher or lower than they should be and you take Saxenda exactly as prescribed, tell your doctor.
  • Saxenda may increase the risk of low blood sugar when used with other medicines that can cause low blood sugar (eg, insulin, sulfonylureas). Low blood sugar may also be more likely to occur if you skip a meal, exercise heavily, or drink alcohol. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you more hungry. Tell your doctor right away if this happens.
  • Severe and sometimes fatal pancreas inflammation (pancreatitis) has been reported in patients taking Saxenda. Call your doctor right away if you develop severe or persistent stomach or back pain (with or without nausea or vomiting).
  • Saxenda may change the way that medicines taken by mouth are absorbed into your body. Be sure your doctor knows about all the medicines you take. Discuss any questions or concerns with your doctor.
  • If you cannot drink liquids by mouth or if you have nausea, vomiting, or diarrhea that does not go away, you will need to take care not to become dehydrated. Contact your doctor for instructions. Dehydration may lead to new or worsening kidney problems.
  • Lab tests may be performed while you use Saxenda. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Saxenda should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Do not use Saxenda if you are pregnant. Weight loss during pregnancy may cause harm to the fetus. If you think you may be pregnant or you want to become pregnant, contact your doctor right away. It is not known if this medicine is found in breast milk. Do not breast-feed while using Saxenda.

Saxenda contraindications

Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.
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You should not use Saxenda if you are allergic to it, or if you have multiple endocrine neoplasia type 2 (tumors in your glands), a personal or family history of medullary thyroid cancer, insulin-dependent diabetes, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin)

Before using Saxenda, tell your doctor if you have stomach problems causing slow digestion, kidney or liver disease, high blood pressure, high triglycerides, or if you have ever had pancreatitis, gallstones, or alcoholism.

You should not breast-feed while using Saxenda.

Never share an injection pen with another person. Sharing injection pens can allow disease such as hepatitis or HIV to pass from one person to another.

Call your doctor at once if you have a serious side effect such as swelling or a lump in your throat area, hoarse voice, trouble swallowing, feeling short of breath, severe pain in your upper stomach spreading to your back, nausea and vomiting, or signs of infection such as fever, chills, sore throat, flu symptoms, mouth sores, or easy bruising or bleeding.

Saxenda is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar.


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Reviews

The results of a survey conducted on ndrugs.com for Saxenda are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Saxenda. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

User reports

3 consumers reported side effects

Did you experience side effects while taking Saxenda drug?
According to the report by ndrugs.com, the below mentioned statistics discuss the number of people who experienced side effects after taking Saxenda drug. Every drug produces at least minor unwanted effects, which we call side effects. The side effects can be bothersome, or they can be minor so patients do not know they are experiencing them. The side effects of the drug depend on the individual, severity of disease, symptom, and associated conditions in the patient. The most deciding factor is the drug dosage. The higher the dosage, the higher the therapeutic result, and the more side effects. Every patient need not have the same intensity of side effect. When the side effects are greater, immediately consult your health care provider.
Users%
No side effects3
100.0%


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Information checked by Dr. Sachin Kumar, MD Pharmacology

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