Glimepiride / rosiglitazone Side Effects

Not all side effects for glimepiride / rosiglitazone 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 glimepiride / rosiglitazone: oral tablet

In addition to its needed effects, some unwanted effects may be caused by glimepiride / rosiglitazone. 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 glimepiride / rosiglitazone:

More common
  • Body aches or pain
  • chills
  • cough
  • difficulty with breathing
  • ear congestion
  • fever
  • headache
  • injury
  • loss of voice
  • nasal congestion
  • runny nose
  • sneezing
  • sore throat
  • unusual tiredness or weakness
Less common
  • Anxiety
  • blurred vision
  • chest pain or discomfort
  • cold sweats
  • coma
  • confusion
  • cool, pale skin
  • decreased urine output
  • depression
  • dilated neck veins
  • dizziness
  • extreme fatigue
  • fast heartbeat
  • increased hunger
  • irregular breathing
  • irregular heartbeat
  • nausea
  • nightmares
  • seizures
  • shakiness
  • slurred speech
  • swelling of the face, fingers, feet, or lower legs
  • tightness in the chest
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • weight gain
Incidence not known
  • Abdominal or stomach pain or tenderness
  • agitation
  • back, leg, or stomach pains
  • bleeding gums
  • bloody, black, or tarry stools
  • blue lips and fingernails
  • coughing that sometimes produces a pink frothy sputum
  • dark urine
  • decreased appetite
  • difficult, fast, or noisy breathing, sometimes with wheezing
  • fluid-filled skin blisters
  • general body swelling
  • hostility
  • increased sweating
  • increased thirst
  • irritability
  • itching or skin rash
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • light-colored stools
  • loss of appetite
  • muscle pain or cramps
  • muscle twitching
  • nosebleeds
  • pain or discomfort in the arms, jaw, back, or neck
  • redness of the skin
  • seizures
  • sensitivity to the sun
  • skin thinness
  • sores, ulcers, or white spots on the lips or in the mouth
  • stupor
  • sweating
  • swollen glands
  • vomiting
  • yellow eyes or skin

Some of the side effects that can occur with glimepiride / rosiglitazone 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:

Less common
  • Lack or loss of strength
Rare
  • Burning, stinging, itching, or redness of the skin not present before treatment
Incidence not known
  • Diarrhea

For Healthcare Professionals

Applies to glimepiride / rosiglitazone: oral tablet

Endocrine

Frequency not reported: Resumption of ovulation in premenopausal, anovulatory women, hormonal imbalance[Ref]

Cardiovascular

Major Adverse Cardiovascular Events:
Overall data from rosiglitazone long-term trials including the RECORD, ADOPT, and DREAM trials (rosiglitazone n=6311; control n=7756) showed no difference in overall mortality or major adverse cardiovascular events; however, a meta-analysis of shorter-term trials suggests and increased risk for myocardial infarction with rosiglitazone compared with placebo.

The RECORD trial (Rosiglitazone evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes; mean age 58 years; 52% male) revealed no significant difference in cardiovascular hospitalization or cardiovascular death (primary outcome) among patients with type 2 diabetes receiving rosiglitazone add-on therapy (n=2220) compared with active control (n=2227); however, there was a significant difference in the incidence of congestive heart failure (secondary endpoint). Patients who had failed metformin or sulfonylurea monotherapy were randomized to add-on rosiglitazone or active control (add-on metformin for those inadequately controlled on sulfonylurea or add-on sulfonylurea for those inadequately controlled on metformin). Patients were treated to a target glycosylated hemoglobin (HbA1c) of 7% or less. Heart failure was reported in 61 patients receiving add-on rosiglitazone and 29 patients receiving active control.

In a retrospective analysis of 42 clinical trials (mean duration 6 months), rosiglitazone was associated with an increased risk of myocardial ischemia compared with combined active or placebo control (2% versus 1.53%). These events included angina pectoris, angina dyspnea, myocardial infarction, coronary thrombosis, myocardial ischemia, coronary artery disease, and coronary artery disorder. There was an increased risk with combination insulin therapy and in patients receiving nitrates for known coronary heart disease.

Cardiovascular Events in Patients with NYHA Class I and II Heart Failure:
An increased risk of cardiovascular events was observed in a 52-week trial in patients with NYHA Class I and II Heart Failure receiving rosiglitazone (n=110) compared with placebo (n=114). These events included: cardiovascular deaths (5% vs 4%), worsening CHF (6% vs 4%), new or worsening edema (25% vs 9%), new or worsening dyspnea (26% vs 17%), increases in CHF medication (33% vs 18%), and cardiovascular hospitalization (19% vs 13%).

Edema:
-Dose-related edema was reported in rosiglitazone clinical trials. In patients receiving rosiglitazone 8 mg in combination with a sulfonylurea, the incidence of edema was 12.4%. In monotherapy trials, edema was reported in 4.8% of patients receiving rosiglitazone (dose not specified). Healthy volunteers receiving rosiglitazone 8 mg once daily for 8 weeks experienced a statistically significant increase in median plasma volume compared with placebo.

Concomitant Administration with Insulin:
-Edema was reported with higher frequency in the rosiglitazone plus insulin combination trials (insulin, 5.4%; and rosiglitazone with insulin 14.7%). Reports of new onset or exacerbation of congestive heart failure occurred at a rate of 1% for insulin alone, 2% (4 mg) and 3% (8 mg) for insulin in combination with rosiglitazone. The coadministration of rosiglitazone and insulin is not recommended.[Ref]

Glimepiride-Rosiglitazone:
Common (1% to 10%): Edema, hypertension
Uncommon (0.1% to 1%): Congestive heart failure

Glimepiride: Common (1% to 10%): Edema, hypertension

Rosiglitazone:
Common (1% to 10%): Edema, hypertension
Uncommon (0.1% to 1%): Congestive heart failure
Frequency not reported: Cardiovascular deaths, myocardial infarction, angina, angina pectoris, angina dyspnea, myocardial infarction, coronary thrombosis, myocardial ischemia, coronary artery disease, coronary artery disorder[Ref]

Respiratory

Glimepiride-Rosiglitazone:
Common (1% to 10%): Nasopharyngitis

Rosiglitazone:
Common (1% to 10%): Upper respiratory infection
Postmarketing reports: Pulmonary edema, pleural effusions[Ref]

Nervous system

Glimepiride-Rosiglitazone:
Common (1% to 10%): Headache, dizziness

Glimepiride:
Common (1% to 10%): Headache, dizziness

Rosiglitazone:
Common (1% to 10%): Headache
Frequency not reported: Stroke[Ref]

General

The most commonly reported adverse reports included headache, hypoglycemia, and nasopharyngitis.[Ref]

Gastrointestinal

Glimepiride:
Common (1% to 10%): Nausea
Rare (less than 0.1%): Vomiting, gastrointestinal pain, diarrhea

Rosiglitazone:
Common (1% to 10%): Diarrhea[Ref]

Hepatic

Glimepiride:
Rare (less than 0.1%): Liver enzyme elevations,
Frequency not reported: Liver function impairment, e.g., cholestasis, jaundice, hepatitis, hepatic porphyria reactions and disulfiram-like reactions

Rosiglitazone:
Postmarketing reports: Hepatitis, hepatic enzyme elevations greater than 3 times the upper limit of normal, hepatic failure[Ref]

Hypersensitivity

Rosiglitazone:
Postmarketing reports: Anaphylactic reaction[Ref]

Dermatologic

Glimepiride:
Rare (less than 0.1%): Allergic skin reactions, e.g. pruritus, erythema, urticaria, and morbilliform or maculopapular eruptions
Frequency not reported: Porphyria cutanea tarda, photosensitivity reactions, allergic vasculitis

Rosiglitazone:
Postmarketing reports: Rash, pruritus, urticaria, angioedema, Stevens-Johnson syndrome[Ref]

Hematologic

Anemia was reported in 1.9% of patients receiving rosiglitazone as monotherapy. When taken in combination with metformin, a sulfonylurea, or metformin plus a sulfonylurea, the incidence of anemia was 7.1%, 2.3%, and 6.7%, respectively. Laboratory findings have shown dose-related decreases in hemoglobin and hematocrit; mean decreases in hemoglobin were 1 g/dL and up to 3.3% in hematocrit. These changes primarily occurred during the first 3 months or following a dose increase. They may be related to increased plasma volume.[Ref]

Glimepiride:
Frequency not reported: Leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia, aplastic anemia, pancytopenia

Rosiglitazone:
Common (1% to 10%): Anemia
Frequency not reported: Decrease in WBC counts[Ref]

Metabolic

Glimepiride-Rosiglitazone:
Common (1% to 10%): Hypoglycemia
Frequency not reported: Weight gain

Glimepiride:
Common (1% to 10%): Hypoglycemia
Frequency not reported: Hyponatremia, syndrome of inappropriate antidiuretic hormone (SIADH) secretion, changes in serum lipids

Rosiglitazone:
Uncommon (0.1% to 1%): Hypoglycemia[Ref]

The mechanism of weight gain is unclear, although it probably is due to a combination of fluid retention and fat accumulation. Dose-related weight gain was observed in trials with the combination glimepiride / rosiglitazone and rosiglitazone alone. Mean weight gain in patients receiving the combination glimepiride 4 mg/rosiglitazone 4 mg was 2.2 kg and 2.9 kg for patients receiving glimepiride 4 mg/rosiglitazone 8 mg.[Ref]

Ocular

Glimepiride:
Uncommon (0.1% to 1%): Blurred vision

Rosiglitazone:
Postmarketing reports: Diabetic macular edema with decreased visual acuity[Ref]

Musculoskeletal

Rosiglitazone:
Common: Back pain, arthralgia,
Frequency not reported: Fractures, bone mineral density decreases[Ref]

Large long-term clinical trials have shown an increased incidence of bone fracture in patients receiving rosiglitazone in combination with sulfonylurea or metformin as rosiglitazone alone. This increased incidence appeared after the first year and persisted. The majority of fractures were observed in women and occurred in the upper arm, hand, and foot.[Ref]

Other

Glimepiride:
Common (1% to 10%): Asthenia

Rosiglitazone:
Common (1% to 10%): Injury[Ref]

References

1. "Product Information. Avandaryl (glimepiride-rosiglitazone)." GlaxoSmithKline, Research Triangle Park, NC.

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
(web2)