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

General

The most commonly reported adverse events included nasopharyngitis and diarrhea.

Metabolic

Linagliptin-Metformin:
Frequency not reported: Hypoglycemia

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

Metformin:
Very rare (less than 0.01%): Lactic acidosis, vitamin B12 deficiency

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).

Gastrointestinal

Linagliptin-Metformin:
Common (1% to 10%): Decreased appetite, diarrhea, nausea, vomiting
Uncommon (0.1% to 1%): Increased blood amylase

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

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

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.

Hypersensitivity

Linagliptin-Metformin:
Rare (less than 0.1%): Drug hypersensitivity

Linagliptin
Postmarketing reports: Serious hypersensitivity reactions

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.

Respiratory

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

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

Metformin
Common (1% to 10%): Nasopharyngitis

Dermatologic

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

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

Hematologic

Metformin
Very rare (less than 0.01%): Megaloblastic anemia

Hepatic

Metformin:
Very rare (less than 0.01%): Hepatitis, liver function test abnormalities

Musculoskeletal

Linagliptin:
Frequency not reported: Myalgia

Nervous system

Metformin:
Common (1% to 10%): Taste disturbance

Genitourinary

Linagliptin:
Common (1% to 10%): Urinary tract infection,

Psychiatric

Linagliptin:
Common (1% to 10%): Headache

Metformin:
Common (1% to 10%): Headache

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.

Hide
(web3)