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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
on Mar 18, 2014 Female from IE , 75 years of age, was diagnosed with and was treated with Dapagliflozin. Directly after, patient experienced the unwanted or unexpected Dapagliflozin side effects: acute myocardial infarction. Dapagliflozin dosage: N/A.
Associated medications used:
  • Saxagliptin
  • Metformin Hcl
  • Lopressor
  • Aspirin
  • Sublingual Nitroglycerin
  • Nitroglycerin Ointment (1 Inch Every 6 Hours)
  • Morphine
  • Zofran
Patient was hospitalized.

Panic Attack, Anxiety
Patient was taking Dapagliflozin. Patient felt the following Dapagliflozin side effects: panic attack, anxiety on Feb 20, 2014 from GB Additional patient health information: Female , 54 years of age, weighting 226.4 lb, . Dapagliflozin dosage: N/A.
Multiple prescriptions taken:
  • Calcium
  • Fluoxetine
  • Gliclazide
  • Lansoprazole
  • Metformin
  • Simvastatin
  • Gabapentin
  • Travoprost


Chest Pain
Adverse event was reported on Feb 03, 2014 by a Male taking Dapagliflozin (Dosage: N/A) was diagnosed with and. Location: GB , 50 years of age, weighting 246.9 lb, After Dapagliflozin was administered, patient encountered several Dapagliflozin side effects: chest pain.
Multiple concurrent drugs taken:
  • Gliclazide
  • Asa
  • Ramipril
  • Simvastatin
  • Liraglutide
Patient was hospitalized.

Back Pain, Thirst
on Jan 21, 2014 Male from GB , 45 years of age, weighting 229.3 lb, was treated with Dapagliflozin. Directly after, patient experienced the unwanted or unexpected Dapagliflozin side effects: back pain, thirst. Dapagliflozin dosage: N/A.
Associated medications used:
  • Gliclazide
  • Metformin
  • Ramipril
  • Simvastatin
  • Candesartan
  • Losartan



Atrial Fibrillation, Diabetic Ketoacidosis, Abdominal Discomfort, Nausea
on Jan 16, 2014 Male from GB , 65 years of age, weighting 195.1 lb, was treated with Dapagliflozin. Patient felt the following Dapagliflozin side effects: atrial fibrillation, diabetic ketoacidosis, abdominal discomfort, nausea. Dapagliflozin dosage: N/A.
Multiple prescriptions taken:
  • Ramipril
  • Sitagliptin Phosphate
  • Aspirin
  • Metformin
Patient was hospitalized.

Nephrolithiasis
Patient was taking Dapagliflozin. After Dapagliflozin was administered, patient encountered several Dapagliflozin side effects: nephrolithiasis on Aug 23, 2011 from UNITED STATES Additional patient health information: Male , 55 years of age, was diagnosed with and. Dapagliflozin dosage: N/A.
Multiple concurrent drugs taken:
  • Allopurinol
  • Metformin Hcl
Patient was hospitalized.

Dehydration, Gastrointestinal Disorder, Nausea, Renal Failure Acute
Adverse event was reported on Dec 20, 2010 by a Male taking Dapagliflozin (Dosage: N/A) was diagnosed with and. Location: AUSTRALIA , 67 years of age, Directly after, patient experienced the unwanted or unexpected Dapagliflozin side effects: dehydration, gastrointestinal disorder, nausea, renal failure acute. Patient was hospitalized.

Benign Prostatic Hyperplasia, Blood Creatine Phosphokinase Increased, Calculus Bladder, Glomerular Filtration Rate Decreased, Haematuria, Urinary Tract Obstruction
on Nov 15, 2010 Male from UNITED KINGDOM , 69 years of age, weighting 211.6 lb, was diagnosed with and was treated with Dapagliflozin. Patient felt the following Dapagliflozin side effects: benign prostatic hyperplasia, blood creatine phosphokinase increased, calculus bladder, glomerular filtration rate decreased, haematuria, urinary tract obstruction. Dapagliflozin dosage: N/A.
Multiple prescriptions taken:
  • Glipizide


Renal Failure Acute
on Sep 28, 2010 Male from AUSTRALIA , 67 years of age, was diagnosed with and was treated with Dapagliflozin. After Dapagliflozin was administered, patient encountered several Dapagliflozin side effects: renal failure acute. Dapagliflozin dosage: N/A. Patient was hospitalized.

Anaemia
Patient was taking Dapagliflozin. Directly after, patient experienced the unwanted or unexpected Dapagliflozin side effects: anaemia on Sep 10, 2010 from ARGENTINA Additional patient health information: Female , 68 years of age, was diagnosed with and. Dapagliflozin dosage: N/A.
Associated medications used:
  • Glipizide


Calculus Bladder
Adverse event was reported on Jul 19, 2010 by a Male taking Dapagliflozin (Dosage: N/A) was diagnosed with and. Location: UNITED KINGDOM , 69 years of age, weighting 211.6 lb, Patient felt the following Dapagliflozin side effects: calculus bladder.
Multiple prescriptions taken:
  • Glipizide


Arteriosclerosis Coronary Artery
on Jun 17, 2010 Male from UNITED STATES , 65 years of age, was diagnosed with and was treated with Dapagliflozin. After Dapagliflozin was administered, patient encountered several Dapagliflozin side effects: arteriosclerosis coronary artery. Dapagliflozin dosage: N/A.
Multiple concurrent drugs taken:
  • 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
Patient was hospitalized.

Hepatic Neoplasm Malignant, Prostate Cancer
on Feb 24, 2010 Male from ARGENTINA , 60 years of age, was diagnosed with and was treated with Dapagliflozin. Directly after, patient experienced the unwanted or unexpected Dapagliflozin side effects: hepatic neoplasm malignant, prostate cancer. Dapagliflozin dosage: Stop Date:10feb09;resume Date:11feb09..
Associated medications used:
  • Glipizide (Stop Date 09feb09;resume Date:11feb09.)
  • Glucophage


Hepatic Neoplasm Malignant, Prostate Cancer
Patient was taking Dapagliflozin. Patient felt the following Dapagliflozin side effects: hepatic neoplasm malignant, prostate cancer on Jul 02, 2009 from ARGENTINA Additional patient health information: Male , 60 years of age, was diagnosed with and. Dapagliflozin dosage: Stop Date:10feb09;resume Date:11feb09..
Multiple prescriptions taken:
  • Glipizide (Stop Date 09feb09;resume Date:11feb09.)
  • Glucophage


Hypoglycaemia, Hypoglycaemic Coma, Loss Of Consciousness
Adverse event was reported on Apr 23, 2009 by a Female taking Dapagliflozin (Dosage: N/A) was diagnosed with and. Location: GERMANY , 57 years of age, After Dapagliflozin was administered, patient encountered several Dapagliflozin side effects: hypoglycaemia, hypoglycaemic coma, loss of consciousness.
Multiple concurrent drugs taken:
  • Glipizide
  • Metformin Hcl
  • Vesdil


Cellulitis, Gangrene
on Apr 23, 2009 Male from UNITED STATES , 59 years of age, was diagnosed with and was treated with Dapagliflozin. Directly after, patient experienced the unwanted or unexpected Dapagliflozin side effects: cellulitis, gangrene. Dapagliflozin dosage: N/A.
Associated medications used:
  • Metformin Hcl
Patient was hospitalized.

Hypoglycaemia
on Apr 23, 2009 Female from GERMANY , 57 years of age, was diagnosed with and was treated with Dapagliflozin. Patient felt the following Dapagliflozin side effects: hypoglycaemia. Dapagliflozin dosage: N/A.
Multiple prescriptions taken:
  • Glipizide
  • Metformin Hcl


Pneumonia, Pulmonary Tuberculosis
Patient was taking Dapagliflozin. After Dapagliflozin was administered, patient encountered several Dapagliflozin side effects: pneumonia, pulmonary tuberculosis on Apr 17, 2009 from SINGAPORE Additional patient health information: Male , 42 years of age, was diagnosed with and. Dapagliflozin dosage: Interrupted On 25feb09.
Multiple concurrent drugs taken:
  • Metformin Hcl (Taken As Metformin Xr. Interrupted On 25feb09)
Patient was hospitalized.

Pneumonia, Pulmonary Tuberculosis
Adverse event was reported on Mar 18, 2009 by a Male taking Dapagliflozin (Dosage: Interrupted On 25feb09) was diagnosed with and. Location: SINGAPORE , 42 years of age, Directly after, patient experienced the unwanted or unexpected Dapagliflozin side effects: pneumonia, pulmonary tuberculosis.
Associated medications used:
  • Metformin Hcl (Taken As Metformin Xr. Interrupted On 25feb09)
Patient was hospitalized.

Pneumonia
on Mar 03, 2009 Male from SINGAPORE , 42 years of age, was diagnosed with and was treated with Dapagliflozin. Patient felt the following Dapagliflozin side effects: pneumonia. Dapagliflozin dosage: Interrupted On 25feb09.
Multiple prescriptions taken:
  • Metformin Hcl (Taken As Metformin Xr. Interrupted On 25feb09)
Patient was hospitalized.

Hypoglycaemia
on Feb 09, 2009 Female from CANADA , 59 years of age, was diagnosed with and was treated with Dapagliflozin. After Dapagliflozin was administered, patient encountered several Dapagliflozin side effects: hypoglycaemia. Dapagliflozin dosage: N/A.
Multiple concurrent drugs taken:
  • Novolin 40/60 (Regimin:biphasic)


Creatinine Renal Clearance Decreased
Patient was taking Dapagliflozin. Directly after, patient experienced the unwanted or unexpected Dapagliflozin side effects: creatinine renal clearance decreased on Jan 06, 2009 from ARGENTINA Additional patient health information: Male , 65 years of age, was diagnosed with and. Dapagliflozin dosage: 2.5 Mg Daily From 04-sep-2008; 5 Mg Daily From 25-sep-2008.

Creatinine Renal Clearance Decreased
Adverse event was reported on Dec 23, 2008 by a Male taking Dapagliflozin (Dosage: 2.5 Mg Daily From 04-sep-2008; 5 Mg Daily From 25-sep-2008) was diagnosed with and. Location: ARGENTINA , 65 years of age, Patient felt the following Dapagliflozin side effects: creatinine renal clearance decreased.

Ventricular Arrhythmia
on Dec 15, 2008 Female from ARGENTINA , 44 years of age, was diagnosed with and was treated with Dapagliflozin. After Dapagliflozin was administered, patient encountered several Dapagliflozin side effects: ventricular arrhythmia. Dapagliflozin dosage: N/A.
Multiple concurrent drugs taken:
  • Glipizide
  • Metformin Hcl
Patient was hospitalized.

Creatinine Renal Clearance Decreased
on Dec 09, 2008 Male from ARGENTINA , 65 years of age, was diagnosed with and was treated with Dapagliflozin. Directly after, patient experienced the unwanted or unexpected Dapagliflozin side effects: creatinine renal clearance decreased. Dapagliflozin dosage: 2.5 Mg Daily From 04-sep-2008; 5 Mg Daily From 25-sep-2008.

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Keep Track of Side Effects

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


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  • 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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    Safety Alerts, Active Ingredients, Usage Information

    More About Dapagliflozin

    Side Effects reported to FDA: 26

    Dapagliflozin safety alerts: No

    Reported hospitalizations: 12

    Latest Dapagliflozin clinical trials

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