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Linagliptin / metformin Side Effects

Not all side effects for linagliptin / metformin may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to linagliptin / metformin: oral tablet

In addition to its needed effects, some unwanted effects may be caused by linagliptin / metformin. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking linagliptin / metformin:

Less common
  • Anxiety
  • blurred vision
  • chills
  • cold sweats
  • coma
  • confusion
  • cool, pale skin
  • depression
  • dizziness
  • fast heartbeat
  • headache
  • increased hunger
  • nausea
  • nightmares
  • seizures
  • shakiness
  • slurred speech
  • unusual tiredness or weakness
Incidence not known
  • Bloating
  • constipation
  • darkened urine
  • fainting spells
  • fever
  • indigestion
  • irregular heartbeat
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of appetite
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • vomiting
  • yellow eyes or skin

Some of the side effects that can occur with linagliptin / metformin may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Diarrhea
  • excess air or gas in the stomach or intestines
  • full feeling
  • heartburn
  • lack or loss of strength
  • muscle aches
  • passing gas
  • sore throat
  • stuffy or runny nose
Incidence not known
  • Cough
  • decreased appetite
  • difficulty with moving
  • flaking and falling off of the skin
  • hives or welts
  • itching
  • joint pain
  • muscle aching or cramping
  • muscle pains or stiffness
  • redness of the skin
  • skin rash
  • swollen joints

For Healthcare Professionals

Applies to linagliptin / metformin: oral tablet


The most commonly reported adverse events included nasopharyngitis and diarrhea.[Ref]


Frequency not reported: Hypoglycemia

Common (1% to 10%): Hypertriglyceridemia, hyperlipidemia, weight increased

Very rare (less than 0.01%): Lactic acidosis, vitamin B12 deficiency[Ref]

Hypoglycemia was more commonly reported in patients receiving the combination linagliptin / metformin plus a sulfonylurea compared with those receiving metformin plus a sulfonylurea (22.9% vs 14.8%; n=792).[Ref]


Common (1% to 10%): Decreased appetite, diarrhea, nausea, vomiting
Uncommon (0.1% to 1%): Increased blood amylase
Postmarketing reports: Mouth ulceration

Common (1% to 10%): Constipation, diarrhea
Frequency not reported: Pancreatitis

Very common (10% or more): Diarrhea, nausea, vomiting, abdominal pain, decreased appetite
Common (1% to 10%): Constipation
Frequency not reported: Flatulence, indigestion[Ref]

Gastrointestinal events such as nausea, vomiting, diarrhea, decreased appetite, and abdominal pain occur most frequently during initiation of therapy and resolve spontaneously in most cases.
During clinical trials, pancreatitis was reported in 15.2 cases per 10,000 patient year exposure in patients receiving linagliptin compared with 3.7 cases per 10,000 patient year exposure in those receiving active comparator (sulfonylurea). Following completion of clinical trials, 3 additional cases of pancreatitis were reported among those receiving linagliptin. Postmarketing reports of acute pancreatitis, including fatalities, have been received.[Ref]


Rare (less than 0.1%): Drug hypersensitivity

Postmarketing reports: Serious hypersensitivity reactions[Ref]

Serious hypersensitivity reactions including anaphylaxis, angioedema, and exfoliative skin conditions have been reported postmarketing in patients treated with linagliptin. These reactions have occurred within the first 3 months, with some occurring after the first dose.[Ref]


Common (1% to 10%): Nasopharyngitis (6.3%),
Uncommon (0.1% to 1%): Cough

Common (1% to 10%): Nasopharyngitis, cough

Common (1% to 10%): Nasopharyngitis[Ref]


Uncommon (0.1% to 1%): Pruritus
Postmarketing reports: Angioedema, urticaria, rash

Very rare (less than 0.01%): Skin reactions such as erythema, pruritus, and urticaria[Ref]


Very rare (less than 0.01%): Megaloblastic anemia[Ref]


Very rare (less than 0.01%): Hepatitis, liver function test abnormalities[Ref]


Frequency not reported: Myalgia, arthralgia[Ref]

Between October 2006 and December 2013, thirty-three cases of severe arthralgia have been reported to the FDA Adverse Event Reporting System Database. Each case involved the use of 1 or more dipeptidyl peptidase-4 (DPP-4) inhibitor. In all cases, substantial reduction in prior activity level was reported, 10 patients were hospitalized due to disabling joint pain. In 22 cases, symptoms appeared within 1 month of starting therapy, in 23 cases symptoms resolved less than 1 month after discontinuation. A positive rechallenge was reported in 8 cases, with 6 cases involving use of a different DPP-4 inhibitor. Sitagliptin had the greatest number of cases reported (n=28) followed by saxagliptin (n=5), linagliptin (n=2), alogliptin (n=1), and vildagliptin (n=2).[Ref]

Nervous system

Common (1% to 10%): Taste disturbance[Ref]


Common (1% to 10%): Urinary tract infection,[Ref]


Common (1% to 10%): Headache

Common (1% to 10%): Headache[Ref]


1. "Product Information. Jentadueto (linagliptin-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

4. US Food and Drug Administration "FDA Drug Safety Communication: FDA warns that DPP-4 inhibitors for type 2 diabetes may cause severe joint pain. Available from: URL:" ([2015, Aug 28]):

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