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Pradaxa Side Effects

Common Pradaxa Side Effects


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

Gastrointestinal Haemorrhage (2001)
Anaemia (738)
Cerebrovascular Accident (730)
Haemorrhage (675)
Fall (571)
Rectal Haemorrhage (533)
Dizziness (423)
Renal Failure Acute (423)
Dyspepsia (391)
Coagulopathy (386)
Haemorrhagic Anaemia (381)
Dyspnoea (367)
Ischaemic Stroke (358)
Contusion (349)
Epistaxis (334)
Nausea (330)
Asthenia (325)
Melaena (319)
Haemoglobin Decreased (316)
Death (303)

➢ 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.

Pradaxa Side Effects Reported to FDA

The following Pradaxa 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 Pradaxa 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.
Tooth Abscess, Dental Caries, Off Label Use
This is a report of a female patient (weight: NA) from CA, suffering from the following symptoms/conditions: pulmonary embolism, who was treated with Pradaxa (dosage: 300 Mg, start time: 2012), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Tooth Abscess
  • Dental Caries
  • Off Label Use
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Pradaxa treatment in female patients, resulting in tooth abscess side effect.

Pulmonary Embolism
This report suggests a potential Pradaxa Pulmonary Embolism side effect(s) that can have serious consequences. A female patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: NA and used Pradaxa (dosage: 75 Mg) starting 201307. Soon after starting Pradaxa the patient began experiencing various side effects, including:
  • Pulmonary Embolism
Drugs used concurrently: NA.The patient was hospitalized. Although Pradaxa demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as pulmonary embolism, may still occur.

Asthenia, Haematemesis, Rectal Haemorrhage, Malaise, Hypophagia, Haemoglobin Decreased, Prothrombin Time Prolonged, Blood Urea Increased, Blood Creatinine Increased
This Asthenia, Haematemesis, Rectal Haemorrhage, Malaise, Hypophagia, Haemoglobin Decreased, Prothrombin Time Prolonged, Blood Urea Increased, Blood Creatinine Increased problem was reported by a pharmacist from US. A 82-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: atrial fibrillation. On Aug 01, 2012 this consumer started treatment with Pradaxa (dosage: NA). The following drugs were being taken at the same time:
  • Sotalol
  • Meclizine
  • Colchicine
  • Glimeperide
  • Loperamide
  • Rosuvastatin
  • Ezitimibe
  • Amlodipine
When commencing Pradaxa, the patient experienced the following unwanted symptoms/side effects:
  • Asthenia
  • Haematemesis
  • Rectal Haemorrhage
  • Malaise
  • Hypophagia
  • Haemoglobin Decreased
  • Prothrombin Time Prolonged
  • Blood Urea Increased
  • Blood Creatinine Increased
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 asthenia, may become evident only after a product is in use by the general population.

Anorgasmia, Loss Of Libido
This is a report of a 85-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: atrial fibrillation and was treated with Pradaxa (dosage: 300 Mg) starting 201302. Concurrently used drugs:
  • Crestor
  • Nexium
Soon after that, the consumer experienced the following side effects:
  • Anorgasmia
  • Loss Of Libido
This opens a possibility that Pradaxa treatment could cause the above reactions, including anorgasmia, and some female subjects may be more susceptible.


Hypoaesthesia
A 62-year-old male patient (weight: NA) from US with the following symptoms/conditions: atrial fibrillation started Pradaxa treatment (dosage: 300 Mg) on 201211. Soon after starting Pradaxa treatment, the subject experienced various side effects, including:
  • Hypoaesthesia
Concurrently used drugs: NA. This finding indicates that some male patients could be more vulnerable to Pradaxa.

Dizziness, Cellulitis, Dyspnoea Exertional, Faeces Discoloured, Haemoptysis
A 79-year-old male patient from US (weight: NA) experienced symptoms, such as: atrial fibrillation,hypertension,blood cholesterol increased and was treated with Pradaxa(dosage: 300 Mg). The treatment was initiated on 2012. After that a consumer reported the following side effect(s):
  • Dizziness
  • Cellulitis
  • Dyspnoea Exertional
  • Faeces Discoloured
  • Haemoptysis
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Pradaxa efficacy: NA.

Gastrointestinal Haemorrhage, Haemorrhagic Anaemia
In this report, Pradaxa was administered for the following condition: atrial fibrillation.A male consumer from US (weight: NA) started Pradaxa treatment (dosage: 300 Mg) on 2008.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Gastrointestinal Haemorrhage
  • Haemorrhagic Anaemia
A possible interaction with other drugs could have contributed to this reaction:
  • Atenolol
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 Pradaxa treatment could be related to the listed above side effect(s).

Hypertensive Crisis, Confusional State
This is a report of the following Pradaxa side effect(s):
  • Hypertensive Crisis
  • Confusional State
A 75-year-old female patient from DE (weight: NA) presented with the following condition: atrial fibrillation and received a treatment with Pradaxa (dosage: 300 Mg) starting: Jan 29, 2014.The following concurrently used drugs could have generated interactions:
  • Metoprolol
This report suggests that a Pradaxa treatment could be associated with the listed above side effect(s).

Arthritis
This Pradaxa report was submitted by a female consumer from US (weight: NA). The patient was diagnosed with: atrial fibrillation,angina pectoris,hypertension,cardiac failure,dyspepsia and Pradaxa was administered (dosage: 150 Mg) starting: 2011. The consumer developed a set of symptoms:
  • Arthritis
Other drugs used simultaneously:
  • Imdur (300 Mg)
  • Lopressor (12.5 Mg)
  • Digoxin (0.125 Mg)
  • Prilosec (40 Mg)
  • Lasix (80 Mg)
  • K-dur Er (40 Meq)
  • Paxil (12.5 Mg)
  • Gabapentin (1200 Mg)
Those unexpected symptoms could be linked to a Pradaxa treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Gastrointestinal Haemorrhage, Haemoglobin Decreased
This is a report of a possible correlation between Pradaxa use and the following symptoms/side effect(s):
  • Gastrointestinal Haemorrhage
  • Haemoglobin Decreased
which could contribute to an assessment of Pradaxa risk profile.A 67-year-old male consumer from US (weight: NA) was suffering from atrial fibrillation and was treated with Pradaxa (dosage: NA) starting Jan 15, 2014.Other concurrent medications:
  • Spironolactone
  • Zosyn
  • Zyvox
  • Atorvastatin
  • Clonidine
  • Imdur
  • Diltiazem
  • Pentasa Cr
The patient was hospitalized.

Cerebrovascular Accident
A 79-year-old female patient from SE (weight: NA) presented with the following symptoms: atrial fibrillation and after a treatment with Pradaxa (dosage: NA) experienced the following side effect(s):
  • Cerebrovascular Accident
The treatment was started on NS. Pradaxa was used in combination with the following drugs: NA.The patient was hospitalized.This report could alert potential Pradaxa consumers.

Paraesthesia
In this report, a 71-year-old female patient from SE (weight: NA) was affected by a possible Pradaxa side effect.The patient was diagnosed with NA. After a treatment with Pradaxa (dosage: NA, start date: NS), the patient experienced the following side effect(s):
  • Paraesthesia
The following simultaneously used drugs could have led to this reaction: NA.The findings here stress that side effects should be taken into consideration when evaluating a Pradaxa treatment.

Pneumonia
This is a report of a 78-year-old male patient from US (weight: NA), who used Pradaxa (dosage: 300 Mg) for a treatment of atrial fibrillation,emphysema,hypertension,blood cholesterol increased,bladder disorder. After starting a treatment on 201309, the patient experienced the following side effect(s):
  • Pneumonia
The following drugs could possibly have interacted with the Pradaxa treatment
  • Advair (Formulation: Inhaler)
  • Amlodipine (5 Mg)
  • Lovestatin (40 Mg)
  • Finasteride (5 Mg)
  • Inhaler
The patient was hospitalized.Taken together, these observations suggest that a Pradaxa treatment could be related to side effect(s), such as Pneumonia.

Arthritis, Alopecia
This arthritis side effect was reported by a consumer or non-health professional from US. A female patient (weight:NA) experienced the following symptoms/conditions: atrial fibrillation,hypertension. The patient was prescribed Pradaxa (dosage: 300 Mg), which was started on 2011. Concurrently used drugs:
  • Atenolol (25 Mg)
  • Lisniopril (5 Mg)
When starting to take Pradaxa the consumer reported the following symptoms:
  • Arthritis
  • Alopecia
These side effects may potentially be related to Pradaxa.

Tooth Abscess, Tooth Fracture, Dyspepsia
This is a Pradaxa side effect report of a 80-year-old female patient (weight:NA) from US, suffering from the following symptoms/conditions: atrial fibrillation,hypertension, who was treated with Pradaxa (dosage:300 Mg, start time: 2013), combined with:
  • Cozaar
, and developed a serious reaction and a tooth abscess side effect. The patient presented with:
  • Tooth Abscess
  • Tooth Fracture
  • Dyspepsia
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Pradaxa treatment in female patients suffering from atrial fibrillation,hypertension, resulting in tooth abscess.

Haemothorax
This report suggests a potential Pradaxa death side effect(s) that can have serious consequences. A 75-year-old male patient from FR (weight:NA) was diagnosed with the following health condition(s): atrial fibrillation and used Pradaxa (dosage: 300 Mg) starting 201308. Soon after starting Pradaxa the patient began experiencing various side effects, including:
  • Haemothorax
Drugs used concurrently:NA. The patient was hospitalized. Although Pradaxa demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as death, may still occur.

Chest Pain
This chest pain problem was reported by a consumer or non-health professional from US. A 64-year-old male patient (weight: NA) was diagnosed with the following medical condition(s): atrial fibrillation.On 201203 a consumer started treatment with Pradaxa (dosage: 300 Mg). The following drugs/medications were being taken at the same time: NA. When commencing Pradaxa, 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 potential side effect risks. Some side effects, such as chest pain, may become evident only after a product is in use by the general population.

Atrial Fibrillation
This is a Pradaxa side effect report of a 80-year-old male patient (weight: NA) from US. The patient developed the following symptoms/conditions: atrial fibrillation and was treated with Pradaxa (dosage: 150 Mg) starting Feb 18, 2014. Concurrently used drugs: NA. Soon after that, the consumer experienced the following of symptoms:
  • Atrial Fibrillation
This opens a possibility that Pradaxa could cause atrial fibrillation and that some male patients may be more susceptible.

Shock Haemorrhagic
A 89-year-old female patient (weight: NA) from FR with the following symptoms: atrial fibrillation started Pradaxa treatment (dosage: NA) on 201311. Soon after starting Pradaxa treatment, the consumer experienced several side effects, including:
  • Shock Haemorrhagic
. Concurrently used drugs:
  • Cordarone
  • Atenol
  • Cortancyl
  • Lexomil 12mg (6 Mg)
  • Stilnox 10mg
  • Coolmetec
  • Xatral
  • Exelon
This finding indicates that some patients can be more vulnerable to developing Pradaxa side effects, such as shock haemorrhagic.

Myocardial Infarction, Chest Discomfort, Dyspnoea, Acute Myocardial Infarction
This myocardial infarction side effect was reported by a physician from GB. A 78-year-old male patient (weight:NA) experienced the following symptoms/conditions: atrial fibrillation.The patient was prescribed Pradaxa (dosage: 150 Mg), which was started on Jan 10, 2014. Concurrently used drugs:
  • Allopurinol
  • Pravastatin
  • Pregabalin
  • Quinine Sulphate
  • Salbutamol
.When starting to take Pradaxa the consumer reported symptoms, such as:
  • Myocardial Infarction
  • Chest Discomfort
  • Dyspnoea
  • Acute Myocardial Infarction
These side effects may potentially be related to Pradaxa. The patient was hospitalized.

Cerebrovascular Accident, Atrial Fibrillation
This is a report of a 44-year-old male patient (weight: NA) from US, suffering from the following symptoms/conditions: atrial fibrillation,heart rate irregular,fluid retention, who was treated with Pradaxa (dosage: 300 Mg, start time: 2012), combined with:
  • Toprol Xl (300 Mg)
  • Spironolactone (50 Mg)
  • Furosemide (80 Mg)
  • Parvastitin (40 Mg)
  • Digoxin
  • Carvedilol (50 Mg)
  • Paxil (20 Mg)
and developed a serious reaction and side effect(s). The consumer presented with:
  • Cerebrovascular Accident
  • Atrial Fibrillation
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Pradaxa treatment in male patients, resulting in cerebrovascular accident side effect. The patient was hospitalized.

Dyspepsia, Limb Injury, Haemorrhage, Eructation
This report suggests a potential Pradaxa Dyspepsia, Limb Injury, Haemorrhage, Eructation side effect(s) that can have serious consequences. A 79-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: atrial fibrillation,blood cholesterol increased,arrhythmia,hypertension and used Pradaxa (dosage: 300 Mg) starting Feb 07, 2014. Soon after starting Pradaxa the patient began experiencing various side effects, including:
  • Dyspepsia
  • Limb Injury
  • Haemorrhage
  • Eructation
Drugs used concurrently:
  • Simvastatin (10 Mg)
  • Sotalol (120 Mg)
  • Sotalol
  • Losartan (100 Mg)
  • Losartan
  • Vitamins
Although Pradaxa demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as dyspepsia, may still occur.

Peripheral Coldness, Pain In Extremity
This Peripheral Coldness, Pain In Extremity problem was reported by a consumer or non-health professional from US. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: atrial fibrillation. On 2011 this consumer started treatment with Pradaxa (dosage: 150 Mg). The following drugs were being taken at the same time:
  • Amiodarone
When commencing Pradaxa, the patient experienced the following unwanted symptoms/side effects:
  • Peripheral Coldness
  • Pain In Extremity
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as peripheral coldness, may become evident only after a product is in use by the general population.

Cerebrovascular Accident
This is a report of a 75-year-old male patient (weight: NA) from PH. The patient developed the following symptoms/conditions: cerebrovascular accident prophylaxis,atrial fibrillation and was treated with Pradaxa (dosage: 15.7143 Mg) starting 201402. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Cerebrovascular Accident
The patient was hospitalized. This opens a possibility that Pradaxa treatment could cause the above reactions, including cerebrovascular accident, and some male subjects may be more susceptible.

Lung Neoplasm Malignant, Dyspnoea, Blister
A 79-year-old female patient (weight: NA) from US with the following symptoms/conditions: atrial fibrillation started Pradaxa treatment (dosage: 300 Mg) on 2012. Soon after starting Pradaxa treatment, the subject experienced various side effects, including:
  • Lung Neoplasm Malignant
  • Dyspnoea
  • Blister
Concurrently used drugs:
  • Cardiazem Xr (240 Mg)
  • Digoxin (0.125 Mg)
  • Vitamin D (20000 U)
  • Advair (Formulation: Inhalation Aerosol; Strength: 1 Inhalation; Daily Dose: 2 Inhalation)
  • Morphine (5 Mg)
  • Omeprazole (20 Mg)
  • Levothyroxine (0.137 Mg)
The patient was hospitalized. This finding indicates that some female patients could be more vulnerable to Pradaxa.

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Top 10 Pradaxa Side Effects for Women

Women Side EffectsReports
Gastrointestinal Haemorrhage 1040
Anaemia 377
Haemorrhage 326
Cerebrovascular Accident 322
Fall 303
Rectal Haemorrhage 259
Dyspepsia 232
Dizziness 220
Nausea 211
Contusion 210

Top 10 Pradaxa Side Effects for Men

Men Side EffectsReports
Gastrointestinal Haemorrhage 942
Cerebrovascular Accident 399
Anaemia 360
Haemorrhage 338
Rectal Haemorrhage 271
Fall 264
Renal Failure Acute 212
Dyspnoea 201
Dizziness 197
Coagulopathy 192

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

    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.


    Discuss Pradaxa Side Effects

    Did You Have a Pradaxa Side Effect?

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    Yes, Moderate
    Yes, Minor
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    How Effective is Pradaxa for You?

    Exceeded Expectations
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    Pradaxa Safety Alerts, Active Ingredients, Usage Information

    NDC0597-0135
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NamePradaxa
    Namedabigatran etexilate mesylate
    Dosage FormCAPSULE
    RouteORAL
    On market since20101026
    LabelerBoehringer Ingelheim Pharmaceuticals Inc.
    Active Ingredient(s)DABIGATRAN ETEXILATE MESYLATE
    Strength(s)150
    Unit(s)mg/1
    Pharma Class

    More About Pradaxa

    Side Effects reported to FDA: 13372

    Pradaxa safety alerts: 2013 2012 2011

    Reported deaths: 2542

    Reported hospitalizations: 7883

    Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication - Safety Review of Post-Market Reports of Serious Bleeding Events

     

    UPDATED 11/02/2012. The FDA evaluated new information about the risk of serious bleeding associated with use of the anticoagulants (blood thinners) dabigatran (Pradaxa) and warfarin (Coumadin, Jantoven, and generics). This assessment was done using insurance claims and administrative data from FDA’s Mini-Sentinel pilot of the Sentinel Initiative. The results of this assessment indicate that bleeding rates associated with new use of Pradaxa do not appear to be higher than bleeding rates associated with new use of warfarin, which is consistent with observations from the large clinical trial used to approve Pradaxa (the RE-LY trial). FDA is continuing to evaluate multiple sources of data in the ongoing safety review of this issue. See the Data Summary in the 11/02/2012 Drug Safety Communication below for additional information.
     
    FDA has not changed its recommendations regarding Pradaxa. Pradaxa provides an important health benefit when used as directed. Healthcare professionals who prescribe Pradaxa should carefully follow the dosing recommendations in the drug label, especially for patients with renal impairment (when kidneys don’t function normally) to reduce the risk of bleeding. Patients with atrial fibrillation should not stop taking Pradaxa without first talking to their healthcare professional. Stopping use of anticoagulant medications such as Pradaxa can increase the risk of stroke. Strokes can lead to permanent disability and death.

     

    Posted 12/07/2011

    AUDIENCE: Cardiology, Pharmacy, Hematology

    ISSUE: (FDA) is evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate mesylate). Bleeding that may lead to serious or even fatal outcomes is a well-recognized complication of all anticoagulant therapies. The Pradaxa drug label contains a warning about significant and sometimes fatal bleeds. In a large clinical trial (18,000 patients) comparing Pradaxa and warfarin, major bleeding events occurred at similar rates with the two drugs.

    FDA is working to determine whether the reports of bleeding in patients taking Pradaxa are occurring more commonly than would be expected, based on observations in the large clinical trial that supported the approval of Pradaxa.

    BACKGROUND: Pradaxa is a blood thinning (anticoagulant) medication used to reduce the risk of stroke in patients with non-valvular atrial fibrillation (AF), the most common type of heart rhythm abnormality.

    RECOMMENDATION: At this time, FDA continues to believe that Pradaxa provides an important health benefit when used as directed and recommends that healthcare professionals who prescribe Pradaxa follow the recommendations in the approved drug label.

    Patients with AF should not stop taking Pradaxa without talking to their healthcare professional. Stopping use of blood thinning medications can increase their risk of stroke. Strokes can lead to permanent disability and death.

    FDA will communicate any new information on the risk of bleeding and Pradaxa when it becomes available.

    Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

    • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
    • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

     

    [11/02/2012 - Drug Safety Communication - FDA]
    [12/07/2011 - Drug Safety Communication - FDA]

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