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Synjardy XR Side Effects

Generic name: empagliflozin / metformin

Medically reviewed by Drugs.com. Last updated on Dec 31, 2023.

Note: This document provides detailed information about Synjardy XR Side Effects associated with empagliflozin / metformin. Some dosage forms listed on this page may not apply specifically to the brand name Synjardy XR.

Applies to empagliflozin / metformin: oral tablet, oral tablet extended release.

Important warnings This medicine can cause some serious health issues

Oral route (tablet; tablet, extended release)

Lactic Acidosis. Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias.

The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain.

Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (greater than 5 mmol/L), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio, and metformin plasma levels generally greater than 5 mcg/mL.

Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (eg, carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (eg, acute congestive heart failure), excessive alcohol intake, and hepatic impairment.Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided in the full prescribing information.If metformin-associated lactic acidosis is suspected, immediately discontinue empagliflozin/metformin hydrochloride and institute general supportive measures in the hospital setting.

Prompt hemodialysis is recommended.

Serious side effects of Synjardy XR

Along with its needed effects, empagliflozin / metformin 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 empagliflozin / metformin:

More common side effects

  • bladder pain
  • bloody or cloudy urine
  • blurred vision
  • chills
  • confusion
  • cool, pale skin
  • decreased appetite
  • difficult, burning, or painful urination
  • discouragement
  • dizziness
  • fast heartbeat
  • fast, shallow breathing
  • feeling sad or empty
  • frequent urge to urinate
  • general feeling of discomfort
  • headache
  • increased hunger
  • irritability
  • lack of appetite
  • loss of consciousness
  • loss of interest or pleasure
  • lower back or side pain
  • muscle pain or cramping
  • nausea
  • nightmares
  • seizures
  • shakiness
  • sleepiness
  • slurred speech
  • stomach discomfort
  • tiredness
  • trouble concentrating
  • trouble sleeping
  • unusual tiredness or weakness

Less common side effects

  • 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

  • dark urine
  • decreased frequency or amount of urine
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • dry mouth
  • fever
  • flushed, dry skin
  • fruit-like breath odor
  • increased thirst
  • itching, skin rash
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
  • light-colored stools
  • pain, tenderness, redness, or swelling of the area between the anus and genitals
  • redness of the skin
  • stomach pain, continuing
  • unexplained weight loss
  • vomiting
  • weight gain
  • yellow eyes or skin

Other side effects of Synjardy XR

Some side effects of empagliflozin / metformin 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 side effects

  • bloated or feeling of fullness
  • diarrhea
  • excess air or gas in stomach or bowels
  • indigestion
  • passing gas
  • stomach discomfort

For healthcare professionals

Applies to empagliflozin / metformin: oral tablet, oral tablet extended release.

General adverse events

The most common adverse reactions associated with empagliflozin were urinary tract infection and female genital mycotic infections. The most common adverse reactions associated with metformin were diarrhea, nausea/vomiting, flatulence, abdominal discomfort, indigestion, asthenia, and headache.[Ref]

Cardiovascular

Empagliflozin:

Adverse reactions related to volume depletion included decreased blood pressure (ambulatory), decreased systolic blood pressure, hypotension, and orthostatic hypotension.

Dermatologic

Empagliflozin:

Metformin:

Gastrointestinal

Empagliflozin:

Metformin:

Gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea, abdominal pain, loss of appetite) occurred most often during initiation of metformin therapy and resolved spontaneously in most cases.

In clinical trials of metformin, diarrhea, nausea/vomiting, flatulence, abdominal discomfort, and indigestion were reported in greater than 5% of patients. In clinical trials of extended-release metformin plus glyburide, diarrhea and nausea were reported in 12.5% and 6.7% of patients, respectively.

Genitourinary

Empagliflozin:

Urinary tract infection included (but was not limited to) asymptomatic bacteriuria, cystitis, and urinary tract infection. Urinary tract infections occurred more often in female patients and were more likely to occur in patients with history of chronic or recurrent urinary tract infections.

Female genital mycotic infections included vulvovaginal mycotic infection, vaginal infection, vulvitis, vulvovaginal candidiasis, genital infection, genital candidiasis, fungal genital infection, genitourinary tract infection, vulvovaginitis, cervicitis, fungal urogenital infection, and bacterial vaginitis. Genital mycotic infections occurred more frequently in female than male patients.

Increased urination included (but was not limited to) polyuria, pollakiuria, and nocturia.

Male genital mycotic infections included balanoposthitis, balanitis, fungal genital infections, genitourinary tract infection, Candida balanitis, scrotal abscess, and penile infection.

Hematologic

Empagliflozin:

Hepatic

Metformin:

Hypersensitivity

Empagliflozin:

Metabolic

Empagliflozin:

Metformin:

The incidence of hypoglycemia increased when empagliflozin was administered with insulin or sulfonylurea. The incidence of overall hypoglycemic events (plasma/capillary glucose 70 mg/dL or less) was 0.4% with empagliflozin monotherapy, up to 1.8% with empagliflozin plus metformin, up to 16.1% with empagliflozin plus metformin plus sulfonylurea, up to 2.4% with empagliflozin plus pioglitazone (with/without metformin), up to 28.4% with empagliflozin plus basal insulin (with/without metformin), and up to 41.3% with empagliflozin plus multiple daily injections of insulin (with/without metformin).

In clinical trials in adults, adverse reactions related to volume depletion (e.g., decreased blood pressure [ambulatory], decreased systolic blood pressure, dehydration, hypotension, hypovolemia, orthostatic hypotension, syncope) were reported in up to 0.5% of patients treated with empagliflozin.

In clinical trials of extended-release metformin plus glyburide, hypoglycemia was reported in 13.7% of patients.

Musculoskeletal

Empagliflozin:

Across 4 empagliflozin outcome trials, lower limb amputation event rates were 4.3 and 5 events per 1000 patient-years in the placebo and empagliflozin groups, respectively. In a long-term cardiorenal outcome trial in patients with chronic kidney disease, lower limb amputations event rates were 2.9 and 4.3 events per 1000 patient-years in the placebo and empagliflozin arms, respectively.

Nervous system

Empagliflozin:

Metformin:

Adverse reactions related to volume depletion included syncope.

In clinical trials of metformin, headache was reported in greater than 5% of patients.

Other

Empagliflozin:

Metformin:

Thirst included polydipsia.

In clinical trials of metformin, asthenia was reported in greater than 5% of patients.

Renal

Empagliflozin:

Respiratory

Empagliflozin:

References

1. (2023) "Product Information. Synjardy (empagliflozin-metformin)." Boehringer Ingelheim, SUPPL-39

2. (2022) "Product Information. Jardiamet (empagliflozin-metformin)." Boehringer Ingelheim Pty Ltd, PI0157-16

3. (2023) "Product Information. Synjardy (empagliflozin-metformin)." Boehringer Ingelheim Ltd

Further information

Synjardy XR 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.