Empagliflozin Side Effects are documented on the FDA prescribing label, and reported separately by patients and doctors to the FDA’s adverse event system. This page sets out what the official record actually says about Empagliflozin: what it is approved to treat, what the label warns about, its recall history, and what the reported side effects are — along with what those figures do and do not mean.
- What Empagliflozin Is Prescribed For, and Where Empagliflozin Side Effects Come From
- Warnings on the Empagliflozin Label
- Warnings Beyond the Common Empagliflozin Side Effects
- Empagliflozin Side Effects Listed on the FDA Label
- Reported Empagliflozin Side Effects in the FDA Database
- Who the Label Says Should Take Extra Care
- Empagliflozin Recall History
- Is Empagliflozin the Subject of Litigation?
- If You Are Worried About Empagliflozin Side Effects
- Frequently Asked Questions
- Official Sources
- Related Guides
Before you read on. Do not stop taking a prescribed medicine, or change how you take it, because of anything you read here. Talk to the prescriber or pharmacist who knows your medical history first.
What Empagliflozin Is Prescribed For, and Where Empagliflozin Side Effects Come From
According to the FDA label, is indicated: to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure. to reduce the risk of sustained decline in eGFR, end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease at risk of progression. to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease. as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. […]
Two separate official sources describe empagliflozin side effects. The prescribing label records what was observed in clinical trials, where the drug was compared against a control group. The FDA’s adverse event database records what patients and clinicians have reported since approval, which is a much larger but far less controlled picture. Both appear below, and they answer different questions.
| Active ingredient | Empagliflozin |
| Brand names on this label | Jardiance |
| How it is given | oral |
| Boxed warning | See the label for this product |
| Recall records | 6 |
| Label last updated | 2026-06-17 |
The FDA has revised this label recently. The label’s own record of recent major changes reads: Indications and Usage ( 1 ) 9/2023 Dosage and Administration ( 2.2 ) 9/2023 Dosage and Administration ( 2.3 ) 6/2023 Dosage and Administration ( 2.4 ) 9/2023 Warnings and Precautions ( 5.1 ) 9/2023 Warnings and Precautions ( 5.4 ) 6/2023 Warnings and Precautio […] A recent revision usually means new safety information was added.
Warnings on the Empagliflozin Label
The FDA prescribing label carries the full set of warnings and precautions for Empagliflozin. Because a medicine can have several approved labels from different manufacturers and formulations, the safest way to see the warnings that apply to the exact product you have is to read the label for that product.
You can look up any product’s current FDA label on DailyMed, the National Library of Medicine’s official label database, using the name on your bottle or box.
Warnings Beyond the Common Empagliflozin Side Effects
The label’s warnings and precautions section describes risks the FDA requires prescribers to weigh. For Empagliflozin it covers: iabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis: Consider ketone monitoring in patients with type 1 diabetes mellitus and consider ketone monitoring in others at risk for ketoacidosis, as indicated.
Assess for ketoacidosis regardless of presenting blood glucose levels and discontinue JARDIANCE if ketoacidosis is suspected. Monitor patients for resolution of ketoacidosis before restarting. ( 5.1 ) Volume Depletion: Before initiating JARDIANCE, assess volume status and renal function in patients with impaired renal function, elderly patients, or patients on loop diuretics.
Monitor for signs and symptoms during therapy. ( 5.2 ) Urosepsis and Pyelonephritis: Evaluate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated. ( 5.3 ) Hypoglycemia: Adult patients taking an insulin secretagogue or insulin may have an increased risk of hypoglycemia. In pediatric patients 10 years of age and older, the risk of hypoglycemia was higher regardless of insulin use. […]
These are the risks the FDA has judged significant enough to state formally, and they sit apart from the routine empagliflozin side effects most people ask about. They apply to different patients to very different degrees, which is why the same medicine can be routine for one person and unsuitable for another.
Empagliflozin Side Effects Listed on the FDA Label
The label’s adverse reactions section records what was observed in clinical trials: he following important adverse reactions are described below and elsewhere in the labeling: Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis [see Warnings and Precautions (5.1) ] Volume Depletion [see Warnings and Precautions (5.2) ] Urosepsis and Pyelonephritis [see Warnings and Precautions (5.3) ] Hypoglycemia [see Warnings and Precautions (5.4) ] Necrotizing Fasciitis of the Perineum (Fournier's Gangrene) [see Warnings and Precautions (5.5) ] Genital Mycotic Infections [see Warnings and Precautions (5.6) ] Hypersensitivity Reactions [see Warnings and Precautions (5.8) ] Most common adverse reactions (5% or greater incidence) were urinary tract infections and female genital mycotic infections ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc. […]
Trial data is the most reliable source for how common empagliflozin side effects are, because the people taking the drug were compared against people who were not. A symptom that appeared just as often in the control group is not caused by the medicine.
Reported Empagliflozin Side Effects in the FDA Database
Reported empagliflozin side effects — and what these numbers do not mean
The FDA’s adverse event database holds 69,331 reports mentioning Empagliflozin, of which 41,654 were classified as serious.
Read those numbers carefully. An adverse event report means somebody told the FDA that something happened to a person taking this medicine. It is not a finding that the medicine caused it. Reports are submitted voluntarily by patients, families, doctors and manufacturers; nobody verifies them; and the same event can be reported more than once.
Report volume tracks how many people take a drug, how new it is, and how much attention it is getting. A widely prescribed medicine will always show more reports than a rarely used one, and reports rise sharply when a drug is in the news or in litigation. A large number here does not mean a drug is dangerous, and a small number does not mean it is safe.
| Most frequently reported | Reports |
|---|---|
| Diabetic Ketoacidosis | 4,145 |
| Nausea | 3,714 |
| Blood Glucose Increased | 3,496 |
| Diarrhoea | 3,230 |
| Weight Decreased | 3,094 |
| Fatigue | 2,923 |
| Vomiting | 2,812 |
| Dizziness | 2,728 |
Source: FDA Adverse Event Reporting System (FAERS), retrieved July 2026. Non-clinical reporting categories such as “off label use” have been excluded from the list above because they describe how a drug was used, not something that happened to a patient.
Who the Label Says Should Take Extra Care
Contraindications. The label states that Empagliflozin should not be used in certain situations: is contraindicated in patients: with a hypersensitivity to empagliflozin or any of the excipients in JARDIANCE, reactions such as angioedema have occurred [see Warnings and Precautions (5.8) ] . Hypersensitivity to empagliflozin or any of the excipients in JARDIANCE. ( 4 )
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Interactions with other medicines. ee Table 4 for clinically relevant interactions with JARDIANCE. Table 4 Clinically Relevant Interactions with JARDIANCE Diuretics Clinical Impact Coadministration of empagliflozin with diuretics resulted in increased urine volume and frequency of voids, which might enhance the potential for volume depletion. Intervention Before initiating JARDIANCE, assess volume status and renal function. In patients with volume depletion, correct this condition before initiating JARDIANCE. […]
Older adults. 8.5 Geriatric Use In glycemic control trials in patients with type 2 diabetes mellitus, a total of 2,721 (32%) patients treated with JARDIANCE were 65 years of age and older, and 491 (6%) were 75 years of age and older. JARDIANCE is expected to have diminished glycemic efficacy in elderly patients with renal impairment [see Use in Specific Populations (8.6) ] . […]
Your pharmacist can check your full medicine list against this in a couple of minutes, including anything bought over the counter, and that check is free.
Empagliflozin Recall History
The FDA enforcement database records 6 recall entries involving Empagliflozin products (6 Class II). A recall almost always concerns specific manufactured batches rather than the medicine itself, and different manufacturers of the same generic drug have separate recall records.
The FDA classifies recalls by how serious the potential consequence is. Class I means a reasonable probability of serious harm or death; Class II means temporary or reversible harm is possible; Class III means the product breaks a regulation but is unlikely to cause harm.
| Date | Class | Recalling firm | Reason |
|---|---|---|---|
| 2024-01-03 | Class II | CARDINAL HEALTHCARE | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. |
| 2023-03-29 | Class II | Boehringer Ingelheim Pharmaceuticals, Inc. | Labeling: Label Mix-up |
| 2021-06-02 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
| 2021-06-02 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
| 2021-06-02 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
If a batch you have was recalled, the pharmacy that dispensed it is the fastest way to find out and to get a replacement. Do not simply stop taking a prescribed medicine because a recall notice exists — the recall may not affect your batch, and stopping can carry its own risk.
Is Empagliflozin the Subject of Litigation?
As of the date on this page, we are not tracking consolidated federal litigation over Empagliflozin. Safety questions have been raised about this medicine, and questions being raised is not the same thing as a case being filed or proven.
We monitor federal court filings and FDA safety communications, and this page is updated when the record changes. Our active case pages list the drug and device litigation currently underway.
If You Are Worried About Empagliflozin Side Effects
Concern about empagliflozin side effects is a good reason to have a conversation, and not a reason to act alone. Do not stop taking a prescribed medicine, or change how you take it, because of anything you read here. Talk to the prescriber or pharmacist who knows your medical history first. Stopping some medicines abruptly carries risks of its own, and your prescriber can tell you whether that applies to yours.
Write down what you have noticed and when it started before the appointment. Not everything that happens while taking a medicine is one of its empagliflozin side effects, and a specific account — what changed, when, and how often — is what lets a clinician tell the difference.
You can also report a side effect directly to the FDA through MedWatch. Reports from patients are part of how safety signals are detected, and filing one takes a few minutes.
Frequently Asked Questions
What are the most commonly reported empagliflozin side effects?
In FDA reports, the most frequently mentioned are diabetic ketoacidosis, nausea, blood glucose increased. The label’s own adverse reactions section, drawn from clinical trials, is the better guide to how common a side effect actually is, because reports to the FDA are not collected in a way that supports rates.
Has Empagliflozin been recalled?
There are 6 recall records for Empagliflozin products, the most recent dated 2024-01-03. Recalls generally affect specific manufactured batches rather than the medicine as a whole. Your pharmacy can tell you whether a batch you have was affected.
Does Empagliflozin have a boxed warning?
A medicine can have several approved labels from different manufacturers, so the reliable answer for the exact product you have is on that product’s label. You can look it up on DailyMed using the name on your packaging.
Do the FDA report numbers tell me how common these empagliflozin side effects are?
No. Reports are unverified, anyone can file one, and the total mostly reflects how many people take the medicine and how much attention it is getting. A high count is not evidence of danger, and a low one is not evidence of safety. Clinical trial data on the label is the source that supports rates.
Where can I check empagliflozin side effects for the exact product I have?
DailyMed holds the current FDA label for every marketed product, searchable by the name on your packaging. Different manufacturers and formulations of the same medicine can have slightly different labels, so checking the one you actually have is worth the two minutes.
Official Sources
- DailyMed (National Library of Medicine) — the current FDA prescribing label for every product
- FDA Adverse Event Reporting System dashboard — the public report data summarised above
- FDA recalls and safety alerts — current recall notices
- FDA MedWatch — how to report a side effect yourself
Related Guides
Medical and legal disclaimer. This page summarises publicly available FDA data about Empagliflozin and is general information, not medical advice, and not legal advice. It is not a substitute for the judgement of a clinician who knows your medical history. Nothing here states that Empagliflozin caused any illness or injury in any individual. Adverse event reports are unverified and do not establish causation.
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FDA labels are revised regularly; confirm current information on DailyMed or with your pharmacist. Do not stop taking a prescribed medicine, or change how you take it, because of anything you read here. Talk to the prescriber or pharmacist who knows your medical history first.