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Synjardy Side Effects

Generic Name: empagliflozin / metformin

Note: This page contains side effects data for the generic drug empagliflozin / metformin. It is possible that some of the dosage forms included below may not apply to the brand name Synjardy.

In Summary

Common side effects of Synjardy include: lactic acidosis, urinary tract infection, and neuropathy. Other side effects include: vulvovaginal candidiasis, bacterial vaginosis, cervicitis, genital candidiasis, genitourinary infection, vaginal infection, vulvitis, vulvovaginitis, and increased ldl cholesterol. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to empagliflozin / metformin: oral tablet

As well as its needed effects, empagliflozin / metformin may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking empagliflozin / metformin, check with your doctor immediately:

More common:
  • Abdominal or stomach discomfort
  • bladder pain
  • bloody or cloudy urine
  • blurred vision
  • chills
  • coma
  • confusion
  • cool, pale skin
  • decreased appetite
  • depression
  • difficult, burning, or painful urination
  • dizziness
  • fast heartbeat
  • fast, shallow breathing
  • frequent urge to urinate
  • general feeling of discomfort
  • headache
  • increased hunger
  • lower back or side pain
  • muscle pain or cramping
  • nausea
  • nightmares
  • seizures
  • shakiness
  • shortness of breath
  • sleepiness
  • slurred speech
  • unusual tiredness or weakness
Less common:
  • Bad-smelling discharge from the penis
  • itching of the vagina or genitals
  • itching, stinging, or redness of the vaginal area
  • redness, itching, swelling, or pain of the penis
  • thick, white vaginal discharge with mild or no odor
Incidence not known:
  • Blurred vision
  • dark-colored urine
  • decreased frequency or amount of urine
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • dry mouth
  • flushed, dry skin
  • fruit-like breath odor
  • increased thirst
  • light-colored stools
  • loss of appetite
  • loss of consciousness
  • stomach pain, continuing
  • swelling of the face, fingers, or lower legs
  • unexplained weight loss
  • vomiting
  • weight gain
  • yellow eyes or skin

Minor Side Effects

Some empagliflozin / metformin side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common:
  • Diarrhea
  • flatulence
  • indigestion
  • stomach discomfort

For Healthcare Professionals

Applies to empagliflozin / metformin: oral tablet

General

Empagliflozin: The most frequently reported side effects included urinary tract infections and female genital mycotic infections.

Metformin: The most frequently reported side effects included diarrhea, nausea, vomiting, flatulence, abdominal discomfort, indigestion, asthenia, and headache.[Ref]

Cardiovascular

Empagliflozin is known to cause osmotic diuresis, leading to intravascular volume contraction and adverse reactions related to volume depletion. Adverse reactions related to volume depletion such as decreased ambulatory/systolic blood pressure, dehydration, hypotension, hypovolemia, orthostatic hypotension, and syncope were reported in 0.5% and 0.3% of patients receiving empagliflozin 10 mg (n=999) or 25 mg (n=977) orally once a day, respectively.[Ref]

Empagliflozin:
Uncommon (0.1% to 1%): Hypotension, orthostatic hypotension, syncope, decreased systolic blood pressure, decreased ambulatory blood pressure[Ref]

Genitourinary

Empagliflozin-Metformin:
Common (1% to 10%): Urinary tract infections

Empagliflozin:
Common (1% to 10%): Urinary tract infections, female genital mycotic infections, male genital mycotic infections, increased urination (e.g., polyuria, pollakiuria, and nocturia)
Uncommon (0.1% to 1%): Dysuria
Rare (less than 0.1%): Phimosis[Ref]

During a 24 week study of empagliflozin in combination with metformin plus a sulfonylurea, urinary tract infections (UTIs) were reported in 9.4% and 6.9% of patients receiving empagliflozin 10 mg (n=224) or 25 mg (n=217) once a day, respectively. Pooled data from 5 studies showed the incidence of UTIs (e.g., UTI, asymptomatic bacteriuria, and cystitis), was increased in empagliflozin-treated patients compared to placebo, more frequent in females compared to males, and more likely to occur in patients with a history of chronic or recurrent UTIs. Treatment discontinuation due to UTIs occurred in 0.2% and 0.1% of patients receiving empagliflozin 10 mg or 25 mg once a day, respectively.[Ref]

Metabolic

The frequency of hypoglycemia depended on the type of background therapy used. When empagliflozin was used as monotherapy, hypoglycemia was reported in 0.4% of patients taking the 10 mg and 25 mg doses. In combination with metformin, hypoglycemia was reported in 1.8% taking 10 mg and 1.4% taking 25 mg. In combination with metformin and a sulfonylurea, hypoglycemia was reported in 16.1% taking the 10 mg dose and 11.5% taking the 25 mg dose. In combination with basal insulin, hypoglycemia was reported in 19.5% taking the 10 mg dose and 28.4% taking the 25 mg dose.

Twenty reports of acidosis, including diabetic ketoacidosis (DKA), ketoacidosis, or ketosis in patients treated with SGLT-2 inhibitors have been identified in the US Food and Drug Administration Adverse Event Reporting System (FAERS) database during the period March 2013 through 06 June 2014. All patients required emergency room treatment or hospitalization. These cases were not typical of ketoacidosis or DKA in that they occurred in patients with type 2 diabetes and their blood sugar levels were only slightly increased. Some factors identified as potentially triggering the acidosis included major illness, reduced food and fluid intake, and reduced insulin dose.[Ref]

Empagliflozin-Metformin:
Very common (10% or more): Hypoglycemia (15.6%)

Empagliflozin:
Common (1% to 10%): Dyslipidemia, polydipsia, increased LDL-C
Uncommon (0.1% to 1%): Dehydration, hypovolemia, hypoglycemia
Frequency not reported: Increased serum creatinine
Postmarketing reports: Acidosis including diabetic ketoacidosis, ketoacidosis, or ketosis

Metformin:
Common (1% to 10%): Decreased vitamin B12 levels
Very rare (less than 0.01%): Lactic acidosis[Ref]

Dermatologic

Empagliflozin-Metformin:
Common (1% to 10%): Pruritus

Metformin:
Very rare (less than 0.01%): Erythema, urticaria[Ref]

Gastrointestinal

Empagliflozin:
Common (1% to 10%): Nausea

Metformin:
Common (1% to 10%): Nausea, vomiting, diarrhea, flatulence, abdominal discomfort, indigestion[Ref]

Hematologic

Empagliflozin:
Common (1% to 10%): Increased hematocrit[Ref]

Hepatic

Metformin:
Very rare (less than 0.01%): Hepatitis, abnormal liver function tests[Ref]

Musculoskeletal

Empagliflozin:
Common (1% to 10%): Arthralgia[Ref]

Nervous system

Metformin:
Common (1% to 10%): Headache, taste disturbances[Ref]

Renal

Empagliflozin:
Frequency not reported: Decreased eGFR[Ref]

Respiratory

Empagliflozin-Metformin:
Common (1% to 10%): Nasopharyngitis

Empagliflozin:
Common (1% to 10%): Upper respiratory tract infection[Ref]

Other

Metformin:
Common (1% to 10%): Asthenia[Ref]

References

1. "Product Information. Synjardy (empagliflozin-metFORMIN)." Boehringer Ingelheim, Ridgefield, CT.

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

3. Cerner Multum, Inc. "Australian Product Information." O 0

It is possible that some side effects of Synjardy may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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