Linagliptin Side Effects

Not all side effects for linagliptin 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: oral tablet

In addition to its needed effects, some unwanted effects may be caused by linagliptin. 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:

More 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
Rare
  • Bloating
  • constipation
  • darkened urine
  • fever
  • indigestion
  • loss of appetite
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • vomiting
  • yellow eyes or skin
Incidence not known
  • Flaking and falling off of the skin
  • hives or welts
  • itching
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • redness of the skin
  • skin rash

Some of the side effects that can occur with linagliptin 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
  • Back pain
  • difficulty with moving
  • muscle aches
  • muscle pain or stiffness
  • pain in the joints
  • sore throat
  • stuffy or runny nose
Less common
  • Cough
  • weight gain

For Healthcare Professionals

Applies to linagliptin: oral tablet

Gastrointestinal

Uncommon (0.1% to 1%): Constipation, increased amylase levels
Frequency not reported: Pancreatitis
Postmarketing reports: Acute pancreatitis[Ref]

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]

General

The most common adverse event reported was nasopharyngitis.[Ref]

Hypersensitivity

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

Frequency not reported: Drug hypersensitivity
Postmarketing reports: Serious hypersensitivity reactions[Ref]

Metabolic

The incidence of hypoglycemia in patients treated with this drug as monotherapy, or in combination with metformin or pioglitazone, was similar to the incidence observed in placebo-treated patients. When given in combination with metformin plus a sulfonylurea, the incidence of hypoglycemia was almost 23% compared to 15% in those receiving placebo with metformin plus a sulfonylurea. As add-on to stable insulin therapy, the incidence of hypoglycemia was similar to placebo (31.4% versus 32.9%).[Ref]

Common (1% to 10%): Hypoglycemia, hypertriglyceridemia, hyperlipidemia, increased uric acid[Ref]

Dermatologic

Postmarketing reports: Rash, angioedema, urticaria[Ref]

Respiratory

Common (1% to 10%): Cough, nasopharyngitis, upper respiratory tract infection[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, arthralgia, extremity pain[Ref]

Nervous system

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

Genitourinary

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

References

1. "Product Information. Tradjenta (linagliptin)." Boehringer Ingelheim, Ridgefield, CT.

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

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

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