Trijardy XR Side Effects
Generic Name: empagliflozin / linagliptin / metformin
Note: This document contains side effect information about empagliflozin / linagliptin / metformin. Some of the dosage forms listed on this page may not apply to the brand name Trijardy XR.
For the Consumer
Applies to empagliflozin/linagliptin/metformin: oral tablet extended release
Warning
You should not use this medicine if you have severe kidney disease (or if you are on dialysis) or diabetic ketoacidosis, or if you have ever had a severe allergic reaction to empagliflozin or linagliptin.
Call your doctor at once if you have signs of a serious side effect, such as severe pain in your upper stomach spreading to your back, vomiting, fast heart rate, dizziness, feeling very thirsty or hot, decreased urination, heavy sweating, or hot and dry skin.
You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. Call your doctor or get emergency medical help if you have unusual muscle pain, trouble breathing, stomach pain, dizziness, feeling cold, or feeling very weak or tired.
In rare cases, this medicine can cause serious infections in the penis or vagina. Get medical help right away if you have burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, fever, or if you don't feel well.
Get emergency medical help if you have signs of an allergic reaction: hives, itching, flaking or peeling skin; trouble swallowing, difficult breathing; swelling of your face, lips, tongue, or throat.
Seek medical attention right away if you have signs of a rare but serious genital infection (penis or vagina): burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, fever, not feeling well. These symptoms may get worse quickly.
Stop taking this medicine and call your doctor at once if you have:
-
severe or ongoing pain in your joints;
-
lactic acidosis--unusual muscle pain, trouble breathing, stomach pain, vomiting, slow or irregular heart rate, dizziness, feeling cold, or feeling very weak or tired;
-
serious skin reaction--itching, blisters, breakdown of the outer layer of skin;
-
ketoacidosis (too much acid in the blood)--nausea, vomiting, stomach pain, confusion, unusual drowsiness, or trouble breathing;
-
pancreatitis--severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
-
dehydration symptoms--dizziness, weakness, feeling light-headed (like you might pass out);
-
signs of a bladder infection--pain or burning when you urinate, blood in your urine, pain in pelvis or back; or
-
symptoms of heart failure--shortness of breath (even while lying down), swelling in your legs or feet, rapid weight gain.
Common side effects may include:
-
stomach pain, diarrhea, constipation;
-
a bladder infection;
-
headache; or
-
cold symptoms such as stuffy nose, sneezing, sore throat.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
For Healthcare Professionals
Applies to empagliflozin / linagliptin / metformin: oral tablet extended release
General
The most commonly reported adverse reactions have included upper respiratory tract infection, urinary tract infection, nasopharyngitis, diarrhea, constipation, headache, and gastroenteritis.[Ref]
Metabolic
Dose-related increases in low-density lipoprotein cholesterol (LDL-C) were observed in patients treated with empagliflozin; increases of 2.3%, 4.6%, and 6.5% occurred in patients treated with placebo, empagliflozin 10 mg, and empagliflozin 25 mg, respectively. Mean baseline LDL-C level increases of 90.3 to 90.6 mg/dL were observed.
Empagliflozin / linagliptin / metformin:
-Uncommon (0.1% to 1%): Hypoglycemia
Empagliflozin:
-Common (1% to 10%): Dyslipidemia
-Postmarketing reports: Ketoacidosis
Linagliptin:
-Common (1% to 10%): Increased uric acid
Metformin:
-Common (1% to 10%): Subnormal vitamin B12 levels
-Postmarketing reports: Lactic acidosis
Empagliflozin, Linagliptin, or Metformin
-Postmarketing reports: Ketoacidosis
Renal
Empagliflozin:
-Frequency not reported: Increased serum creatinine, decreased eGFR
-Postmarketing reports: Acute kidney injury
Hypersensitivity
Linagliptin:
-Frequency not reported: Hypersensitivity (urticaria, angioedema, localized skin exfoliation, or bronchial hyperreactivity)
Empagliflozin, Linagliptin, or Metformin
-Postmarketing reports: Hypersensitivity reactions including anaphylaxis, angioedema, and exfoliative skin conditions
Musculoskeletal
Empagliflozin:
-Common (1% to 10%): Arthralgia
Linagliptin:
-Frequency not reported: Myalgia
Empagliflozin, Linagliptin, or Metformin
-Postmarketing reports: Severe and disabling arthralgia, rhabdomyolysis
Dermatologic
Empagliflozin, Linagliptin, or Metformin
Postmarketing reports: Bullous Pemphigoid, skin reactions (e.g., rash, urticaria)
Gastrointestinal
Empagliflozin / linagliptin / metformin:
-Common (1% to 10%): Diarrhea, constipation, gastroenteritis
Empagliflozin:
-Common (1% to 10%): Nausea, thirst, polydipsia
Linagliptin:
-Common (1% to 10%): Increased lipase levels
-Postmarketing reports: Acute pancreatitis, including fatal pancreatitis
Metformin:
-Common (1% to 10%): Nausea, vomiting, flatulence, abdominal discomfort, indigestion
Empagliflozin, Linagliptin, or Metformin
-Postmarketing reports: Mouth ulceration, stomatitis
Cardiovascular
Empagliflozin / linagliptin / metformin:
-Common (1% to 10%): Volume depletion (hypotension, syncope)
Respiratory
Empagliflozin / linagliptin / metformin:
-Very common (10% or more): Upper respiratory tract infection (up to 10.3%)
-Common (1% to 10%): Nasopharyngitis
Linagliptin:
-Common (1% to 10%): Cough
Hepatic
Empagliflozin, Linagliptin, or Metformin
Postmarketing reports: Cholestatic, hepatocellular, and mixed hepatocellular liver injury
Other
Metformin:
-Common (1% to 10%): Asthenia
Hematologic
Empagliflozin:
-Common (1% to 10%): Increased hematocrit
Genitourinary
Empagliflozin / linagliptin / metformin:
-Very common (10% or more): Urinary tract infection (up to 10.2%)
Empagliflozin:
-Common (1% to 10%): Genital mycotic infections, increased urination, male genital infections
Empagliflozin, Linagliptin, or Metformin
-Postmarketing reports: Urosepsis, pyelonephritis, necrotizing fasciitis of the perineum (Fournier's gangrene)
Nervous system
Empagliflozin / linagliptin / metformin:
-Common (1% to 10%): Headache
References
1. "Product Information. Trijardy XR (empagliflozin / linagliptin / metformin)." Boehringer Ingelheim, Ridgefield, CT.
More about Trijardy XR (empagliflozin / linagliptin / metformin)
- During Pregnancy
- Dosage Information
- Drug Images
- Drug Interactions
- Pricing & Coupons
- En Español
- Drug class: antidiabetic combinations
- FDA Alerts (5)
- FDA Approval History
Consumer resources
Professional resources
Related treatment guides
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.