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Dapagliflozin Side Effects

Common Dapagliflozin Side Effects


The most commonly reported Dapagliflozin side effects (click to view or check a box to report):

Creatinine Renal Clearance Decreased (3)
Pneumonia (3)
Hypoglycaemia (3)
Calculus Bladder (2)
Renal Failure Acute (2)
Pulmonary Tuberculosis (2)
Nausea (2)
Hepatic Neoplasm Malignant (2)
Prostate Cancer (2)
Atrial Fibrillation (1)
Back Pain (1)
Urinary Tract Obstruction (1)
Acute Myocardial Infarction (1)
Benign Prostatic Hyperplasia (1)
Abdominal Discomfort (1)
Ventricular Arrhythmia (1)
Arteriosclerosis Coronary Artery (1)
Anxiety (1)
Angioedema (1)
Anaemia (1)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Dapagliflozin Side Effects Reported to FDA

The following Dapagliflozin reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Dapagliflozin on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
Acute Myocardial Infarction
This is a report of a 75-year-old female patient (weight: NA) from IE, suffering from the following symptoms/conditions: type 2 diabetes mellitus, who was treated with Dapagliflozin (dosage: NA, start time: Jan 10, 2013), combined with:
  • Saxagliptin
  • Metformin Hcl
  • Lopressor
  • Aspirin
  • Sublingual Nitroglycerin
  • Nitroglycerin Ointment (1 Inch Every 6 Hours)
  • Morphine
  • Zofran
and developed a serious reaction and side effect(s). The consumer presented with:
  • Acute Myocardial Infarction
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Dapagliflozin treatment in female patients, resulting in acute myocardial infarction side effect. The patient was hospitalized.

Panic Attack, Anxiety
This report suggests a potential Dapagliflozin Panic Attack, Anxiety side effect(s) that can have serious consequences. A 54-year-old female patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: NA and used Dapagliflozin (dosage: NA) starting Jan 16, 2014. Soon after starting Dapagliflozin the patient began experiencing various side effects, including:
  • Panic Attack
  • Anxiety
Drugs used concurrently:
  • Calcium
  • Fluoxetine
  • Gliclazide
  • Lansoprazole
  • Metformin
  • Simvastatin
  • Gabapentin
  • Travoprost
Although Dapagliflozin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as panic attack, may still occur.

Chest Pain
This Chest Pain problem was reported by a consumer or non-health professional from GB. A 50-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus. On Jan 08, 2014 this consumer started treatment with Dapagliflozin (dosage: NA). The following drugs were being taken at the same time:
  • Gliclazide
  • Asa
  • Ramipril
  • Simvastatin
  • Liraglutide
When commencing Dapagliflozin, the patient experienced the following unwanted symptoms/side effects:
  • Chest Pain
The patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as chest pain, may become evident only after a product is in use by the general population.

Back Pain, Thirst
This is a report of a 45-year-old male patient (weight: NA) from GB. The patient developed the following symptoms/conditions: NA and was treated with Dapagliflozin (dosage: NA) starting Dec 23, 2013. Concurrently used drugs:
  • Gliclazide
  • Metformin
  • Ramipril
  • Simvastatin
  • Candesartan
  • Losartan
Soon after that, the consumer experienced the following side effects:
  • Back Pain
  • Thirst
This opens a possibility that Dapagliflozin treatment could cause the above reactions, including back pain, and some male subjects may be more susceptible.


Atrial Fibrillation, Diabetic Ketoacidosis, Abdominal Discomfort, Nausea
A 65-year-old male patient (weight: NA) from GB with the following symptoms/conditions: NA started Dapagliflozin treatment (dosage: NA) on Sep 06, 2013. Soon after starting Dapagliflozin treatment, the subject experienced various side effects, including:
  • Atrial Fibrillation
  • Diabetic Ketoacidosis
  • Abdominal Discomfort
  • Nausea
Concurrently used drugs:
  • Ramipril
  • Sitagliptin Phosphate
  • Aspirin
  • Metformin
The patient was hospitalized. This finding indicates that some male patients could be more vulnerable to Dapagliflozin.

Nephrolithiasis
A 55-year-old male patient from UNITED STATES (weight: NA) experienced symptoms, such as: type 2 diabetes mellitus,hyperuricaemia and was treated with Dapagliflozin(dosage: NA). The treatment was initiated on Feb 14, 2011. After that a consumer reported the following side effect(s):
  • Nephrolithiasis
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Dapagliflozin efficacy:
  • Allopurinol
  • Metformin Hcl
The patient was hospitalized.

Dehydration, Gastrointestinal Disorder, Nausea, Renal Failure Acute
In this report, Dapagliflozin was administered for the following condition: type 2 diabetes mellitus.A 67-year-old male consumer from AUSTRALIA (weight: NA) started Dapagliflozin treatment (dosage: NA) on Aug 20, 2010.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Dehydration
  • Gastrointestinal Disorder
  • Nausea
  • Renal Failure Acute
A possible interaction with other drugs could have contributed to this reaction: NA.The patient was hospitalized.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Dapagliflozin treatment could be related to the listed above side effect(s).

Benign Prostatic Hyperplasia, Blood Creatine Phosphokinase Increased, Calculus Bladder, Glomerular Filtration Rate Decreased, Haematuria, Urinary Tract Obstruction
This is a report of the following Dapagliflozin side effect(s):
  • Benign Prostatic Hyperplasia
  • Blood Creatine Phosphokinase Increased
  • Calculus Bladder
  • Glomerular Filtration Rate Decreased
  • Haematuria
  • Urinary Tract Obstruction
A 69-year-old male patient from UNITED KINGDOM (weight: NA) presented with the following condition: type 2 diabetes mellitus and received a treatment with Dapagliflozin (dosage: NA) starting: May 06, 2008.The following concurrently used drugs could have generated interactions:
  • Glipizide
This report suggests that a Dapagliflozin treatment could be associated with the listed above side effect(s).

Renal Failure Acute
This Dapagliflozin report was submitted by a 67-year-old male consumer from AUSTRALIA (weight: NA). The patient was diagnosed with: type 2 diabetes mellitus and Dapagliflozin was administered (dosage: NA) starting: Sep 28, 2010. The consumer developed a set of symptoms:
  • Renal Failure Acute
Other drugs used simultaneously: NA.The patient was hospitalized.Those unexpected symptoms could be linked to a Dapagliflozin treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Anaemia
This is a report of a possible correlation between Dapagliflozin use and the following symptoms/side effect(s):
  • Anaemia
which could contribute to an assessment of Dapagliflozin risk profile.A 68-year-old female consumer from ARGENTINA (weight: NA) was suffering from type 2 diabetes mellitus and was treated with Dapagliflozin (dosage: NA) starting Jan 07, 2010.Other concurrent medications:
  • Glipizide


Calculus Bladder
A 69-year-old male patient from UNITED KINGDOM (weight: NA) presented with the following symptoms: type 2 diabetes mellitus and after a treatment with Dapagliflozin (dosage: NA) experienced the following side effect(s):
  • Calculus Bladder
The treatment was started on May 06, 2008. Dapagliflozin was used in combination with the following drugs:
  • Glipizide
This report could alert potential Dapagliflozin consumers.

Arteriosclerosis Coronary Artery
In this report, a 65-year-old male patient from UNITED STATES (weight: NA) was affected by a possible Dapagliflozin side effect.The patient was diagnosed with type 2 diabetes mellitus. After a treatment with Dapagliflozin (dosage: NA, start date: Oct 15, 2005), the patient experienced the following side effect(s):
  • Arteriosclerosis Coronary Artery
The following simultaneously used drugs could have led to this reaction:
  • Metformin Hcl (Previosly Taken From 02apr05-29oct07)
  • Actos (Actos 15;07aug08-15sep08(15mg) Actos 30;16sep08-19oct08(30mg) Actos 45;20oct08-02feb09(45mg))
  • Niaspan
  • Protonix
  • Hctz
  • Flonase
  • Aspirin
The patient was hospitalized.The findings here stress that side effects should be taken into consideration when evaluating a Dapagliflozin treatment.

Hepatic Neoplasm Malignant, Prostate Cancer
This is a report of a 60-year-old male patient from ARGENTINA (weight: NA), who used Dapagliflozin (dosage: Stop Date:10feb09;resume Date:11feb09.) for a treatment of type 2 diabetes mellitus. After starting a treatment on Feb 09, 2009, the patient experienced the following side effect(s):
  • Hepatic Neoplasm Malignant
  • Prostate Cancer
The following drugs could possibly have interacted with the Dapagliflozin treatment
  • Glipizide (Stop Date 09feb09;resume Date:11feb09.)
  • Glucophage
Taken together, these observations suggest that a Dapagliflozin treatment could be related to side effect(s), such as Hepatic Neoplasm Malignant, Prostate Cancer.

Hepatic Neoplasm Malignant, Prostate Cancer
This hepatic neoplasm malignant side effect was reported by a health professional from ARGENTINA. A 60-year-old male patient (weight:NA) experienced the following symptoms/conditions: type 2 diabetes mellitus. The patient was prescribed Dapagliflozin (dosage: Stop Date:10feb09;resume Date:11feb09.), which was started on Feb 09, 2009. Concurrently used drugs:
  • Glipizide (Stop Date 09feb09;resume Date:11feb09.)
  • Glucophage
When starting to take Dapagliflozin the consumer reported the following symptoms:
  • Hepatic Neoplasm Malignant
  • Prostate Cancer
These side effects may potentially be related to Dapagliflozin.

Hypoglycaemia, Hypoglycaemic Coma, Loss Of Consciousness
This is a Dapagliflozin side effect report of a 57-year-old female patient (weight:NA) from GERMANY, suffering from the following symptoms/conditions: type 2 diabetes mellitus, who was treated with Dapagliflozin (dosage:NA, start time: Oct 27, 2008), combined with:
  • Glipizide
  • Metformin Hcl
  • Vesdil
, and developed a serious reaction and a hypoglycaemia side effect. The patient presented with:
  • Hypoglycaemia
  • Hypoglycaemic Coma
  • Loss Of Consciousness
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Dapagliflozin treatment in female patients suffering from type 2 diabetes mellitus, resulting in hypoglycaemia.

Cellulitis, Gangrene
This report suggests a potential Dapagliflozin cellulitis side effect(s) that can have serious consequences. A 59-year-old male patient from UNITED STATES (weight:NA) was diagnosed with the following health condition(s): type 2 diabetes mellitus and used Dapagliflozin (dosage: NA) starting Feb 10, 2009. Soon after starting Dapagliflozin the patient began experiencing various side effects, including:
  • Cellulitis
  • Gangrene
Drugs used concurrently:
  • Metformin Hcl
The patient was hospitalized. Although Dapagliflozin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as cellulitis, may still occur.

Hypoglycaemia
This hypoglycaemia problem was reported by a health professional from GERMANY. A 57-year-old female patient (weight: NA) was diagnosed with the following medical condition(s): type 2 diabetes mellitus.On Oct 27, 2008 a consumer started treatment with Dapagliflozin (dosage: NA). The following drugs/medications were being taken at the same time:
  • Glipizide
  • Metformin Hcl
When commencing Dapagliflozin, the patient experienced the following unwanted symptoms /side effects:
  • Hypoglycaemia
Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as hypoglycaemia, may become evident only after a product is in use by the general population.

Pneumonia, Pulmonary Tuberculosis
This is a Dapagliflozin side effect report of a 42-year-old male patient (weight: NA) from SINGAPORE. The patient developed the following symptoms/conditions: type 2 diabetes mellitus and was treated with Dapagliflozin (dosage: Interrupted On 25feb09) starting Dec 23, 2008. Concurrently used drugs:
  • Metformin Hcl (Taken As Metformin Xr. Interrupted On 25feb09)
Soon after that, the consumer experienced the following of symptoms:
  • Pneumonia
  • Pulmonary Tuberculosis
The patient was hospitalized. This opens a possibility that Dapagliflozin could cause pneumonia and that some male patients may be more susceptible.

Pneumonia, Pulmonary Tuberculosis
A 42-year-old male patient (weight: NA) from SINGAPORE with the following symptoms: type 2 diabetes mellitus started Dapagliflozin treatment (dosage: Interrupted On 25feb09) on Dec 23, 2008. Soon after starting Dapagliflozin treatment, the consumer experienced several side effects, including:
  • Pneumonia
  • Pulmonary Tuberculosis
. Concurrently used drugs:
  • Metformin Hcl (Taken As Metformin Xr. Interrupted On 25feb09)
The patient was hospitalized. This finding indicates that some patients can be more vulnerable to developing Dapagliflozin side effects, such as pneumonia.

Pneumonia
This pneumonia side effect was reported by a consumer or non-health professional from SINGAPORE. A 42-year-old male patient (weight:NA) experienced the following symptoms/conditions: type 2 diabetes mellitus.The patient was prescribed Dapagliflozin (dosage: Interrupted On 25feb09), which was started on Dec 23, 2008. Concurrently used drugs:
  • Metformin Hcl (Taken As Metformin Xr. Interrupted On 25feb09)
.When starting to take Dapagliflozin the consumer reported symptoms, such as:
  • Pneumonia
These side effects may potentially be related to Dapagliflozin. The patient was hospitalized.

Hypoglycaemia
This is a report of a 59-year-old female patient (weight: NA) from CANADA, suffering from the following symptoms/conditions: type 2 diabetes mellitus, who was treated with Dapagliflozin (dosage: NA, start time: Nov 27, 2008), combined with:
  • Novolin 40/60 (Regimin:biphasic)
and developed a serious reaction and side effect(s). The consumer presented with:
  • Hypoglycaemia
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Dapagliflozin treatment in female patients, resulting in hypoglycaemia side effect.

Creatinine Renal Clearance Decreased
This report suggests a potential Dapagliflozin Creatinine Renal Clearance Decreased side effect(s) that can have serious consequences. A 65-year-old male patient (weight: NA) from ARGENTINA was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus and used Dapagliflozin (dosage: 2.5 Mg Daily From 04-sep-2008; 5 Mg Daily From 25-sep-2008) starting Sep 04, 2008. Soon after starting Dapagliflozin the patient began experiencing various side effects, including:
  • Creatinine Renal Clearance Decreased
Drugs used concurrently: NA. Although Dapagliflozin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as creatinine renal clearance decreased, may still occur.

Creatinine Renal Clearance Decreased
This Creatinine Renal Clearance Decreased problem was reported by a health professional from ARGENTINA. A 65-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus. On Sep 04, 2008 this consumer started treatment with Dapagliflozin (dosage: 2.5 Mg Daily From 04-sep-2008; 5 Mg Daily From 25-sep-2008). The following drugs were being taken at the same time: NA. When commencing Dapagliflozin, the patient experienced the following unwanted symptoms/side effects:
  • Creatinine Renal Clearance Decreased
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as creatinine renal clearance decreased, may become evident only after a product is in use by the general population.

Ventricular Arrhythmia
This is a report of a 44-year-old female patient (weight: NA) from ARGENTINA. The patient developed the following symptoms/conditions: type 2 diabetes mellitus and was treated with Dapagliflozin (dosage: NA) starting Jun 08, 2008. Concurrently used drugs:
  • Glipizide
  • Metformin Hcl
Soon after that, the consumer experienced the following side effects:
  • Ventricular Arrhythmia
The patient was hospitalized. This opens a possibility that Dapagliflozin treatment could cause the above reactions, including ventricular arrhythmia, and some female subjects may be more susceptible.

Creatinine Renal Clearance Decreased
A 65-year-old male patient (weight: NA) from ARGENTINA with the following symptoms/conditions: type 2 diabetes mellitus started Dapagliflozin treatment (dosage: 2.5 Mg Daily From 04-sep-2008; 5 Mg Daily From 25-sep-2008) on Sep 04, 2008. Soon after starting Dapagliflozin treatment, the subject experienced various side effects, including:
  • Creatinine Renal Clearance Decreased
Concurrently used drugs: NA. This finding indicates that some male patients could be more vulnerable to Dapagliflozin.

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Note Your Observations

It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    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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    Side Effects reported to FDA: 26

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    Reported hospitalizations: 12

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