Metaglip
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Metaglip
Metaglip Side Effects Center
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Metaglip in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired.
Stop taking this medication and call your doctor at once if you have a serious side effect such as:
- feeling short of breath, even with mild exertion, swelling or rapid weight gain;
- pain or burning with urination;
- nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
- dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).
Less serious side effects may include:
- cold symptoms such as stuffy nose, sneezing, sore throat;
- headache, dizziness;
- mild nausea, vomiting, diarrhea, stomach pain; or
- joint or muscle pain.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Metaglip (Glipizide and Metformin) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Metaglip Overview - Patient Information: Side Effects
Nausea, diarrhea, stomach upset, muscle aches, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. If stomach symptoms return later (after you are on the same dose for several days or weeks), tell your doctor immediately. Stomach symptoms that occur after the first days of your treatment may be a sign of lactic acidosis.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these rare but very serious side effects occur: easy bleeding/bruising, signs of infection (e.g., persistent sore throat, fever), persistent nausea, severe stomach/abdominal pain, yellowing eyes/skin, dark urine.
This medication may cause low blood sugar (hypoglycemia), especially if you take other medications for diabetes, drink large amounts of alcohol, do unusually heavy exercise, or do not consume enough calories from food. Symptoms include cold sweat, blurred vision, dizziness, drowsiness, shaking, fast heartbeat, headache, fainting, tingling of the hands/feet, and hunger. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor about the reaction immediately. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist to find out what you should do if you miss a meal.
Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor immediately. Your dosage may need to be increased.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Metaglip (Glipizide and Metformin)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Metaglip FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
Metaglip (glipizide and metformin)
In a double-blind 24-week clinical trial involving METAGLIP (glipizide and metformin) as initial therapy, a total of 172 patients received METAGLIP (glipizide and metformin) 2.5 mg/250 mg, 173 received METAGLIP (glipizide and metformin) 2.5 mg/500 mg, 170 received glipizide, and 177 received metformin. The most common clinical adverse events in these treatment groups are listed in Table 4.
Table 4: Clinical Adverse Events > 5% in any Treatment
Group, by Primary Term, in Initial Therapy Study
| Adverse Event | Number (%) of Patients | |||
| Glipizide 5 mg tablets N=170 |
Metformin 500 mg tablets N=177 |
METAGLIP 2.5 mg/250 mg tablets N=172 |
METAGLIP 2.5 mg/500 mg tablets N=173 |
|
| Upper respiratory infection | 12 (7.1) | 15 (8.5) | 17 (9.9) | 14 (8.1) |
| Diarrhea | 8 (4.7) | 15 (8.5) | 4 (2.3) | 9 (5.2) |
| Dizziness | 9 (5.3) | 2 (1.1) | 3 (1.7) | 9 (5.2) |
| Hypertension | 17 (10.0) | 10 (5.6) | 5 (2.9) | 6 (3.5) |
| Nausea/vomiting | 6 (3.5) | 9 (5.1) | 1 (0.6) | 3 (1.7) |
In a double-blind 18-week clinical trial involving METAGLIP (glipizide and metformin) as second-line therapy, a total of 87 patients received METAGLIP (glipizide and metformin) , 84 received glipizide, and 75 received metformin. The most common clinical adverse events in this clinical trial are listed in Table 5.
Table 5: Clinical Adverse Events > 5% in any Treatment
Group, by Primary Term, in Second- Line Therapy Study
| Adverse Event | Number (%) of Patients | ||
| Glipizide 5 mg tabletsa N=84 |
Metformin 500 mg tabletsa N=75 |
METAGLIP 5 mg/500 mg tabletsa N=87 |
|
| Diarrhea | 11 (13.1) | 13 (17.3) | 16 (18.4) |
| Headache | 5 (6.0) | 4 (5.3) | 11 (12.6) |
| Upper respiratory infection | 11 (13.1) | 8 (10.7) | 9 (10.3) |
| Musculoskeletal pain | 6 (7.1) | 5 (6.7) | 7 (8.0) |
| Nausea/vomiting | 5 (6.0) | 6 (8.0) | 7 (8.0) |
| Abdominal pain | 7 (8.3) | 5 (6.7) | 5 (5.7) |
| UTI | 4 (4.8) | 6 (8.0) | 1 (1.1) |
| a The dose of glipizide was fixed at 30 mg daily; doses of metformin and METAGLIP were titrated. | |||
Hypoglycemia
In a controlled initial therapy trial of METAGLIP (glipizide and metformin) 2.5 mg/250 mg and 2.5 mg/500 mg the numbers of patients with hypoglycemia documented by symptoms (such as dizziness, shakiness, sweating, and hunger) and a fingerstick blood glucose measurement ≤ 50 mg/dL were 5 (2.9%) for glipizide, 0 (0%) for metformin, 13 (7.6%) for METAGLIP (glipizide and metformin) 2.5 mg/250 mg, and 16 (9.3%) for METAGLIP (glipizide and metformin) 2.5 mg/500 mg. Among patients taking either METAGLIP (glipizide and metformin) 2.5 mg/250 mg or METAGLIP (glipizide and metformin) 2.5 mg/500 mg, 9 (2.6%) patients discontinued METAGLIP (glipizide and metformin) due to hypoglycemic symptoms and 1 required medical intervention due to hypoglycemia. In a controlled second-line therapy trial of METAGLIP (glipizide and metformin) 5 mg/500 mg, the numbers of patients with hypoglycemia documented by symptoms and a fingerstick blood glucose measurement ≤ 50 mg/dL were 0 (0%) for glipizide, 1 (1.3%) for metformin, and 11 (12.6%) for METAGLIP (glipizide and metformin) . One (1.1%) patient discontinued METAGLIP (glipizide and metformin) therapy due to hypoglycemic symptoms and none required medical intervention due to hypoglycemia. (See PRECAUTIONS.)
Gastrointestinal Reactions
Among the most common clinical adverse events in the initial therapy trial were diarrhea and nausea/vomiting; the incidences of these events were lower with both METAGLIP (glipizide and metformin) dosage strengths than with metformin therapy. There were 4 (1.2%) patients in the initial therapy trial who discontinued METAGLIP (glipizide and metformin) therapy due to gastrointestinal (GI) adverse events. Gastrointestinal symptoms of diarrhea, nausea/vomiting, and abdominal pain were comparable among METAGLIP (glipizide and metformin) , glipizide and metformin in the second-line therapy trial. There were 4 (4.6%) patients in the second-line therapy trial who discontinued METAGLIP (glipizide and metformin) therapy due to GI adverse events.
Glipizide
Gastrointestinal Reactions
Cholestatic and hepatocellular forms of liver injury accompanied by jaundice have been reported rarely in association with glipizide; METAGLIP (glipizide and metformin) should be discontinued if this occurs.
Read the entire FDA prescribing information for Metaglip (Glipizide and Metformin) »
Additional Metaglip Information
Metaglip - User Reviews
Metaglip User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Here is a collection of user reviews for the medication Metaglip sorted by most helpful.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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