metformin
Brand names: Glucophage, Fortamet, Glumetza
ZITUVIMET is a drug that combines two medicines, sitagliptin and metformin. It helps lower blood sugar in adults with type 2 diabetes, when used with diet and exercise.
Drug Pricing (NADAC)
Generic Price
$0.64/unit
Generic Available
Yes (52 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
ZITUVIMET is used to help control blood sugar levels in adults who have type 2 diabetes.
Common side effects
Diarrhea, Upper respiratory tract infection (like a cold), Headache
Key warnings
ZITUVIMET can cause a serious side effect called lactic acidosis.
How It Works
ZITUVIMET works in two ways. Sitagliptin helps your body release more insulin after you eat and lowers the amount of sugar your liver makes. Metformin helps your body use insulin better and also lowers the amount of sugar your liver makes.
How to Take It
Take ZITUVIMET twice a day with your meals. Your doctor will decide the right dose for you based on how well the medicine is working and how you tolerate it. The highest dose you can take each day is 100 mg of sitagliptin and 2,000 mg of metformin. Do not split or divide the tablets.
Pregnancy & Breastfeeding
Talk to your doctor if you are pregnant or plan to become pregnant. It is not known if ZITUVIMET will harm your unborn baby. Talk to your doctor if you are breastfeeding or plan to breastfeed.
Missed Dose
If you miss a dose of ZITUVIMET, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take your next dose at the regular time.
Storage
Store ZITUVIMET at room temperature, away from moisture.
Side Effects (from patient reports)
Based on 171,728 FDA adverse event reports.
FDA Adverse Event Report Analysis
Detailed analysis of 342,023 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2001–2025.
Total Reports
342,023
Death-Related Reports
28,446
Hospitalization Reports
122,330
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | NAUSEA | 21,946 |
| 2 | DIARRHOEA | 21,884 |
| 3 | BLOOD GLUCOSE INCREASED | 18,328 |
| 4 | DRUG INEFFECTIVE | 18,262 |
| 5 | FATIGUE | 17,252 |
| 6 | ACUTE KIDNEY INJURY | 16,440 |
| 7 | LACTIC ACIDOSIS | 16,154 |
| 8 | VOMITING | 14,690 |
| 9 | DYSPNOEA | 13,513 |
| 10 | OFF LABEL USE | 13,250 |
| 11 | DIZZINESS | 12,131 |
| 12 | WEIGHT DECREASED | 11,985 |
| 13 | HEADACHE | 11,890 |
| 14 | PAIN | 11,567 |
| 15 | ASTHENIA | 10,467 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
ZITUVIMET can cause a serious side effect called lactic acidosis. This is a buildup of lactic acid in your blood. It can be life-threatening. Get medical help right away if you have symptoms like weakness, muscle pain, trouble breathing, sleepiness, or stomach pain.
Known Drug Interactions
Metformin ↑ Metformin Refer to the prescribing information of metformin for assessing the benefit and risk of concomitant use of BIKTARVY and metformin.
Mechanism: This HIV medication can increase the amount of metformin that stays in your blood. This happens because the medicine interferes with how metformin is cleared from your system.
What to do: Your doctor should watch you closely for metformin side effects and may need to lower your metformin dose.
7.2 Potential for DOVATO to Affect Other Drugs Dolutegravir, a component of DOVATO, inhibits the renal organic cation transporters (OCT)2 and multidrug and toxin extrusion transporter (MATE)1; thus, it may increase plasma concentrations of drugs eliminated via OCT2 or MATE1 such as dofetilide, dalfampridine, and metformin [see Contraindications ( 4 ), Drug Interactions ( 7.4 ), Clinical Pharmacology ( 12.3 )]. Antidiabetic: Metformin a ↑Metformin Refer to the prescribing information for metformin for assessing the benefit and risk of concomitant use of DOVATO and metformin.
Mechanism: Dolutegravir blocks the proteins that help your kidneys remove metformin, which can lead to higher levels of metformin in your blood.
What to do: Talk to your doctor about the risks of this combination, as they may need to adjust your metformin treatment.
Drugs that Reduce Metformin Clearance Clinical Impact Concomitant use of drugs that interfere with common renal tubular transport systems involved in the renal elimination of metformin (e.g., organic cationic transporter-2 [OCT2] / multidrug and toxin extrusion [MATE] inhibitors such as ranolazine, vandetanib, dolutegravir, and cimetidine) could increase systemic exposure to metformin and may increase the risk for lactic acidosis [see Clinical Pharmacology (12.3) ] . Alcohol Clinical Impact Alcohol is known to potentiate the effect of metformin on lactate metabolism. ( 7 ) Drugs that Reduce...
Mechanism: Using these medicines together can increase the risk of a dangerous buildup of lactic acid in the blood. This risk is higher when other factors, such as alcohol, change how the body handles metformin.
What to do: Your doctor should monitor you for signs of acid buildup and may need to adjust your treatment plan.
Drugs that Reduce Metformin Clearance Clinical Impact Concomitant use of drugs that interfere with common renal tubular transport systems involved in the renal elimination of metformin (e.g., organic cationic transporter-2 [OCT2] / multidrug and toxin extrusion [MATE] inhibitors such as ranolazine, vandetanib, dolutegravir, and cimetidine) could increase systemic exposure to metformin and may increase the risk for lactic acidosis [see Clinical Pharmacology (12.3) ] . Alcohol Clinical Impact Alcohol is known to potentiate the effect of metformin on lactate metabolism. ( 7 ) Drugs that Reduce...
Mechanism: Taking these medications together can cause metformin to build up in your blood because the kidneys cannot remove it as quickly. This increase can lead to a dangerous condition where too much acid builds up in your blood.
What to do: Your doctor should monitor your kidney function and may need to adjust your medication doses.
7 DRUG INTERACTIONS Table 3: Clinically Significant Drug Interactions with SEGLUROMET Carbonic Anhydrase Inhibitors Clinical Impact: The risk of lactic acidosis may increase due to concomitant use of Topiramate or other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide or dichlorphenamide) with metformin. Drugs that Reduce Metformin Clearance Clinical Impact: The risk of lactic acidosis may increase due to concomitant use of drugs that interfere with common renal tubular transport systems involved in the renal elimination of metformin (e.g., organic cationic transporter-2 [OCT2...
Mechanism: Taking these drugs together can increase the risk of a dangerous buildup of lactic acid in the blood, especially if the kidneys are not clearing the medicine properly.
What to do: Your doctor should monitor your kidney function and check for signs of acid buildup in your blood regularly.
Common Questions
Can I take ZITUVIMET if I have kidney problems?
Will ZITUVIMET cause me to lose weight?
Can ZITUVIMET cause low blood sugar?
Can I drink alcohol while taking ZITUVIMET?
What should I do if I have severe stomach pain?
Can ZITUVIMET cause heart problems?
Do I need to check my vitamin B12 levels while taking ZITUVIMET?
What are the symptoms of a serious allergic reaction?
Can ZITUVIMET cause joint pain?
Will I need surgery while taking ZITUVIMET?
What are the common side effects of metformin?
Does metformin interact with other medications?
What drug class is metformin?
Is metformin safe during pregnancy?
Has metformin been recalled?
Active Recalls
CGMP Deviations
Glenmark Pharmaceuticals Inc., USA
Presence of Foreign Tablets/Capsules.
A-S Medication Solutions LLC
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.
Nostrum Laboratories Inc
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Nostrum Laboratories Inc
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Granules Pharmaceuticals Inc
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Amneal Pharmaceuticals of New York, LLC
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Amneal Pharmaceuticals of New York, LLC
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Amneal Pharmaceuticals of New York, LLC
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Amneal Pharmaceuticals of New York, LLC
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Amneal Pharmaceuticals of New York, LLC
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Amneal Pharmaceuticals of New York, LLC
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What the FDA Data Shows for metformin
The FDA label for metformin (sold under brand names such as Glucophage, Fortamet, Glumetza) classifies it as a prescription-only medication in the Biguanide class. ZITUVIMET is used to help control blood sugar levels in adults who have type 2 diabetes. Official labeling lists 3 commonly reported side effects, including Diarrhea, Upper respiratory tract infection (like a cold), Headache.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 171,728 voluntary reports. The database also lists 27 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $0.64.
Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 11 recall records on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: June 9, 2025
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages