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Dapagliflozin Side Effects

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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.

Dapagliflozin Side Effects Reported to FDA



Dapagliflozin Side Effect Report#9920292
Acute Myocardial Infarction
This is a report of a 75-year-old female patient (weight: NA) from IE, suffering from the following health 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): Acute Myocardial Infarction 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.
Dapagliflozin Side Effect Report#9912142
Panic Attack, Anxiety
This report suggests a potential Dapagliflozin Panic Attack 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. After starting Dapagliflozin the patient began experiencing various side effects, including: Panic Attack, AnxietyAdditional 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.
Dapagliflozin Side Effect Report#9861594
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 using Dapagliflozin, the patient experienced the following unwanted symptoms/side effects: Chest PainThe 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.
Dapagliflozin Side Effect Report#9832550
Back Pain, Thirst
This Back Pain side effect was reported by a consumer or non-health professional from GB. A 45-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Dapagliflozin (drug dosage: NA), which was initiated on
Dec 23, 2013. Concurrently used drugs:
  • Gliclazide
  • Metformin
  • Ramipril
  • Simvastatin
  • Candesartan
  • Losartan
.After starting to take Dapagliflozin the consumer reported adverse symptoms, such as: Back Pain, ThirstThese side effects may potentially be related to Dapagliflozin.
Dapagliflozin Side Effect Report#9824213
Atrial Fibrillation, Diabetic Ketoacidosis, Abdominal Discomfort, Nausea
This is a report of a 65-year-old male patient (weight: NA) from GB, suffering from the following health symptoms/conditions: NA, who was treated with Dapagliflozin (dosage: NA, start time:
Sep 06, 2013), combined with:
  • Ramipril
  • Sitagliptin Phosphate
  • Aspirin
  • Metformin
and developed a serious reaction and side effect(s): Atrial Fibrillation, Diabetic Ketoacidosis, Abdominal Discomfort, Nausea after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Dapagliflozin treatment in male patients, resulting in Atrial Fibrillation side effect. The patient was hospitalized.
Dapagliflozin Side Effect Report#7752939-7
Nephrolithiasis
This report suggests a potential Dapagliflozin Nephrolithiasis side effect(s) that can have serious consequences. A 55-year-old male patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus,hyperuricaemia and used Dapagliflozin (dosage: NA) starting
Feb 14, 2011. After starting Dapagliflozin the patient began experiencing various side effects, including: NephrolithiasisAdditional drugs used concurrently:
  • Allopurinol
  • Metformin Hcl
The patient was hospitalized. Although Dapagliflozin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Nephrolithiasis, may still occur.
Dapagliflozin Side Effect Report#7204431-6
Dehydration, Gastrointestinal Disorder, Nausea, Renal Failure Acute
This Dehydration problem was reported by a health professional from Australia. A 67-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus. On
Aug 20, 2010 this consumer started treatment with Dapagliflozin (dosage: NA). The following drugs were being taken at the same time: NA. When using Dapagliflozin, the patient experienced the following unwanted symptoms/side effects: Dehydration, Gastrointestinal Disorder, Nausea, Renal Failure AcuteThe 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 Dehydration, may become evident only after a product is in use by the general population.
Dapagliflozin Side Effect Report#7114639-6
Benign Prostatic Hyperplasia, Blood Creatine Phosphokinase Increased, Calculus Bladder, Glomerular Filtration Rate Decreased, Haematuria, Urinary Tract Obstruction
This Benign Prostatic Hyperplasia side effect was reported by a consumer or non-health professional from United Kingdom. A 69-year-old male patient (weight:NA) experienced the following symptoms/conditions: type 2 diabetes mellitus.The patient was prescribed Dapagliflozin (drug dosage: NA), which was initiated on
May 06, 2008. Concurrently used drugs:
  • Glipizide
.After starting to take Dapagliflozin the consumer reported adverse symptoms, such as: Benign Prostatic Hyperplasia, Blood Creatine Phosphokinase Increased, Calculus Bladder, Glomerular Filtration Rate Decreased, Haematuria, Urinary Tract ObstructionThese side effects may potentially be related to Dapagliflozin.
Dapagliflozin Side Effect Report#7036426-X
Renal Failure Acute
This is a report of a 67-year-old male patient (weight: NA) from Australia, suffering from the following health symptoms/conditions: type 2 diabetes mellitus, who was treated with Dapagliflozin (dosage: NA, start time:
Sep 28, 2010), combined with: NA. and developed a serious reaction and side effect(s): Renal Failure Acute after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Dapagliflozin treatment in male patients, resulting in Renal Failure Acute side effect. The patient was hospitalized.
Dapagliflozin Side Effect Report#7006528-2
Anaemia
This report suggests a potential Dapagliflozin Anaemia side effect(s) that can have serious consequences. A 68-year-old female patient (weight: NA) from Argentina was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus and used Dapagliflozin (dosage: NA) starting
Jan 07, 2010. After starting Dapagliflozin the patient began experiencing various side effects, including: AnaemiaAdditional drugs used concurrently:
  • Glipizide
Although Dapagliflozin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Anaemia, may still occur.
Dapagliflozin Side Effect Report#6887065-2
Calculus Bladder
This Calculus Bladder problem was reported by a consumer or non-health professional from United Kingdom. A 69-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus. On
May 06, 2008 this consumer started treatment with Dapagliflozin (dosage: NA). The following drugs were being taken at the same time:
  • Glipizide
When using Dapagliflozin, the patient experienced the following unwanted symptoms/side effects: Calculus BladderAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Calculus Bladder, may become evident only after a product is in use by the general population.
Dapagliflozin Side Effect Report#6790305-1
Arteriosclerosis Coronary Artery
This Arteriosclerosis Coronary Artery side effect was reported by a health professional from United States. A 65-year-old male patient (weight:NA) experienced the following symptoms/conditions: type 2 diabetes mellitus.The patient was prescribed Dapagliflozin (drug dosage: NA), which was initiated on
Oct 15, 2005. Concurrently used drugs:
  • 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
.After starting to take Dapagliflozin the consumer reported adverse symptoms, such as: Arteriosclerosis Coronary ArteryThese side effects may potentially be related to Dapagliflozin. The patient was hospitalized.
Dapagliflozin Side Effect Report#6616364-4
Hepatic Neoplasm Malignant, Prostate Cancer
This is a report of a 60-year-old male patient (weight: NA) from Argentina, suffering from the following health symptoms/conditions: type 2 diabetes mellitus, who was treated with Dapagliflozin (dosage: Stop Date:10feb09;resume Date:11feb09., start time:
Feb 09, 2009), combined with:
  • Glipizide (Stop Date 09feb09;resume Date:11feb09.)
  • Glucophage
and developed a serious reaction and side effect(s): Hepatic Neoplasm Malignant, Prostate Cancer after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Dapagliflozin treatment in male patients, resulting in Hepatic Neoplasm Malignant side effect.
Dapagliflozin Side Effect Report#6267564-7
Hepatic Neoplasm Malignant, Prostate Cancer
This report suggests a potential Dapagliflozin Hepatic Neoplasm Malignant side effect(s) that can have serious consequences. A 60-year-old male patient (weight: NA) from Argentina was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus and used Dapagliflozin (dosage: Stop Date:10feb09;resume Date:11feb09.) starting
Feb 09, 2009. After starting Dapagliflozin the patient began experiencing various side effects, including: Hepatic Neoplasm Malignant, Prostate CancerAdditional drugs used concurrently:
  • Glipizide (Stop Date 09feb09;resume Date:11feb09.)
  • Glucophage
Although Dapagliflozin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hepatic Neoplasm Malignant, may still occur.
Dapagliflozin Side Effect Report#6179759-1
Hypoglycaemia, Hypoglycaemic Coma, Loss Of Consciousness
This Hypoglycaemia problem was reported by a health professional from Germany. A 57-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus. On
Oct 27, 2008 this consumer started treatment with Dapagliflozin (dosage: NA). The following drugs were being taken at the same time:
  • Glipizide
  • Metformin Hcl
  • Vesdil
When using Dapagliflozin, the patient experienced the following unwanted symptoms/side effects: Hypoglycaemia, Hypoglycaemic Coma, Loss Of ConsciousnessAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hypoglycaemia, may become evident only after a product is in use by the general population.
Dapagliflozin Side Effect Report#6179757-8
Cellulitis, Gangrene
This Cellulitis side effect was reported by a health professional from United States. A 59-year-old male patient (weight:NA) experienced the following symptoms/conditions: type 2 diabetes mellitus.The patient was prescribed Dapagliflozin (drug dosage: NA), which was initiated on
Feb 10, 2009. Concurrently used drugs:
  • Metformin Hcl
.After starting to take Dapagliflozin the consumer reported adverse symptoms, such as: Cellulitis, GangreneThese side effects may potentially be related to Dapagliflozin. The patient was hospitalized.
Dapagliflozin Side Effect Report#6170516-9
Hypoglycaemia
This is a report of a 57-year-old female patient (weight: NA) from Germany, suffering from the following health symptoms/conditions: type 2 diabetes mellitus, who was treated with Dapagliflozin (dosage: NA, start time:
Oct 27, 2008), combined with:
  • Glipizide
  • Metformin Hcl
and developed a serious reaction and side effect(s): Hypoglycaemia 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.
Dapagliflozin Side Effect Report#6160605-7
Pneumonia, Pulmonary Tuberculosis
This report suggests a potential Dapagliflozin Pneumonia side effect(s) that can have serious consequences. A 42-year-old male patient (weight: NA) from Singapore was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus and used Dapagliflozin (dosage: Interrupted On 25feb09) starting
Dec 23, 2008. After starting Dapagliflozin the patient began experiencing various side effects, including: Pneumonia, Pulmonary TuberculosisAdditional drugs used concurrently:
  • Metformin Hcl (Taken As Metformin Xr. Interrupted On 25feb09)
The patient was hospitalized. Although Dapagliflozin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pneumonia, may still occur.
Dapagliflozin Side Effect Report#6135162-1
Pneumonia, Pulmonary Tuberculosis
This Pneumonia problem was reported by a consumer or non-health professional from Singapore. A 42-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus. On
Dec 23, 2008 this consumer started treatment with Dapagliflozin (dosage: Interrupted On 25feb09). The following drugs were being taken at the same time:
  • Metformin Hcl (Taken As Metformin Xr. Interrupted On 25feb09)
When using Dapagliflozin, the patient experienced the following unwanted symptoms/side effects: Pneumonia, Pulmonary TuberculosisThe 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 Pneumonia, may become evident only after a product is in use by the general population.
Dapagliflozin Side Effect Report#6113088-7
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 (drug dosage: Interrupted On 25feb09), which was initiated on
Dec 23, 2008. Concurrently used drugs:
  • Metformin Hcl (Taken As Metformin Xr. Interrupted On 25feb09)
.After starting to take Dapagliflozin the consumer reported adverse symptoms, such as: PneumoniaThese side effects may potentially be related to Dapagliflozin. The patient was hospitalized.
Dapagliflozin Side Effect Report#6085785-3
Hypoglycaemia
This is a report of a 59-year-old female patient (weight: NA) from Canada, suffering from the following health 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): Hypoglycaemia 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.
Dapagliflozin Side Effect Report#6041884-3
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. After starting Dapagliflozin the patient began experiencing various side effects, including: Creatinine Renal Clearance DecreasedAdditional 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.
Dapagliflozin Side Effect Report#6026441-7
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 using Dapagliflozin, the patient experienced the following unwanted symptoms/side effects: Creatinine Renal Clearance DecreasedAlthough 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.
Dapagliflozin Side Effect Report#6020414-6
Ventricular Arrhythmia
This Ventricular Arrhythmia side effect was reported by a health professional from Argentina. A 44-year-old female patient (weight:NA) experienced the following symptoms/conditions: type 2 diabetes mellitus.The patient was prescribed Dapagliflozin (drug dosage: NA), which was initiated on
Jun 08, 2008. Concurrently used drugs:
  • Glipizide
  • Metformin Hcl
.After starting to take Dapagliflozin the consumer reported adverse symptoms, such as: Ventricular ArrhythmiaThese side effects may potentially be related to Dapagliflozin. The patient was hospitalized.
Dapagliflozin Side Effect Report#6013293-4
Creatinine Renal Clearance Decreased
This is a report of a 65-year-old male patient (weight: NA) from Argentina, suffering from the following health symptoms/conditions: type 2 diabetes mellitus, who was treated with Dapagliflozin (dosage: 2.5 Mg Daily From 04-sep-2008; 5 Mg Daily From 25-sep-2008, start time:
Sep 04, 2008), combined with: NA. and developed a serious reaction and side effect(s): Creatinine Renal Clearance Decreased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Dapagliflozin treatment in male patients, resulting in Creatinine Renal Clearance Decreased side effect.


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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.

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

    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.

    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.

    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.

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    Side Effects reported to FDA: 26

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    Reported hospitalizations: 12

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