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Bisoprolol Side Effects

Common Bisoprolol Side Effects


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

Bradycardia (141)
Dyspnoea (104)
Renal Failure Acute (91)
Fall (89)
Dizziness (89)
Hypotension (88)
Syncope (82)
Atrial Fibrillation (76)
Malaise (74)
Nausea (73)
Hyperkalaemia (69)
Diarrhoea (68)
Fatigue (65)
Loss Of Consciousness (54)
Asthenia (52)
Vomiting (51)
Renal Failure (47)
Cardiac Failure (45)
Confusional State (42)
Hyponatraemia (42)

➢ 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.

Bisoprolol Side Effects Reported to FDA

The following Bisoprolol 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 Bisoprolol 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.
Bradycardia, Syncope, Ventricular Extrasystoles, Headache, Blood Pressure Systolic Increased, Anaemia
This is a report of a 76-year-old female patient (weight: NA) from IT, suffering from the following symptoms/conditions: cardiac failure, who was treated with Bisoprolol (dosage: (1.25 Mg, 1 D) , Oral, start time: Jun 01, 2013), combined with:
  • Eutirox (levothyroxine Sodium)
  • Tareg (valsartan)
and developed a serious reaction and side effect(s). The consumer presented with:
  • Bradycardia
  • Syncope
  • Ventricular Extrasystoles
  • Headache
  • Blood Pressure Systolic Increased
  • Anaemia
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Bisoprolol treatment in female patients, resulting in bradycardia side effect. The patient was hospitalized.

Syncope, Face Injury, Chest Injury
This report suggests a potential Bisoprolol (bisoprolol) Syncope, Face Injury, Chest Injury side effect(s) that can have serious consequences. A 75-year-old male patient (weight: NA) from IT was diagnosed with the following symptoms/conditions: NA and used Bisoprolol (bisoprolol) (dosage: NA) starting Jan 01, 2013. Soon after starting Bisoprolol (bisoprolol) the patient began experiencing various side effects, including:
  • Syncope
  • Face Injury
  • Chest Injury
Drugs used concurrently:
  • Amiodarone (amiodarone)
  • Coumadin (warfarin Sodium)
  • Rosuvastatin Calcium (rosuvastatin Calcium)
  • Acetylsalicylic Acid (acetylsalicylic Acid)
  • Lansoprazole (lansoprazole)
Although Bisoprolol (bisoprolol) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as syncope, may still occur.

Febrile Neutropenia
This Febrile Neutropenia problem was reported by a consumer or non-health professional from US. A 33-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Bisoprolol Fumarate Tablets (dosage: Unk Mg, Unk). The following drugs were being taken at the same time:
  • Fluorouracil (Unk Df, Unk)
  • Epirubicin Hydrochloride (Unk Df, Unk)
  • Cyclophosphamide (Unk Df, Unk)
  • Lamivudine (Unk Df, Unk)
When commencing Bisoprolol Fumarate Tablets, the patient experienced the following unwanted symptoms/side effects:
  • Febrile Neutropenia
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as febrile neutropenia, may become evident only after a product is in use by the general population.

Angina Pectoris
This is a report of a 68-year-old male patient (weight: NA) from GB. The patient developed the following symptoms/conditions: hypertension and was treated with Bisoprolol (dosage: NA) starting Mar 13, 2013. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Angina Pectoris
This opens a possibility that Bisoprolol treatment could cause the above reactions, including angina pectoris, and some male subjects may be more susceptible.


Angina Pectoris
A 68-year-old male patient (weight: NA) from GB with the following symptoms/conditions: hypertension,angina pectoris started Bisoprolol (bisoprolol) treatment (dosage: NA) on Jan 23, 2013. Soon after starting Bisoprolol (bisoprolol) treatment, the subject experienced various side effects, including:
  • Angina Pectoris
Concurrently used drugs: NA. This finding indicates that some male patients could be more vulnerable to Bisoprolol (bisoprolol).

Arterial Thrombosis, Pain In Extremity, Muscle Spasms, Alopecia, Mobility Decreased, Varicose Vein
A 67-year-old male patient from GB (weight: NA) experienced symptoms, such as: coronary artery disease,hypertension,cardiovascular disorder and was treated with Bisoprolol(dosage: NA). The treatment was initiated on Aug 20, 2007. After that a consumer reported the following side effect(s):
  • Arterial Thrombosis
  • Pain In Extremity
  • Muscle Spasms
  • Alopecia
  • Mobility Decreased
  • Varicose Vein
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Bisoprolol efficacy:
  • Amlodipine
  • Clopidogrel
  • Quinapril
  • Ranitidine


Angina Pectoris
In this report, Bisoprolol was administered for the following condition: hypertension,angina pectoris.A 68-year-old male consumer from GB (weight: NA) started Bisoprolol treatment (dosage: NA) on Feb 14, 2012.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Angina Pectoris
A possible interaction with other drugs could have contributed to this reaction: NA.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Bisoprolol treatment could be related to the listed above side effect(s).

Somnolence, Hyponatraemia, Hypokalaemia
This is a report of the following Bisoprolol side effect(s):
  • Somnolence
  • Hyponatraemia
  • Hypokalaemia
A 86-year-old female patient from FR (weight: NA) presented with the following condition: NA and received a treatment with Bisoprolol (dosage: 5 Mg Daily) starting: May 29, 2013.The following concurrently used drugs could have generated interactions:
  • Candesartan (16 Mg/day)
  • Lansoprazole (15 Mg/day)
  • Amiodarone (1 Df/day)
  • Metformin (850 Mg/day)
  • Furosemide Teva (60 Mg/day)
  • Previscan (0.5 Df Daily)
  • Dermoval (One Application Daily)
  • Paroex (Unk)
This report suggests that a Bisoprolol treatment could be associated with the listed above side effect(s).

Vaginal Haemorrhage
This Bisoprolol-ct 5 Mg report was submitted by a 75-year-old female consumer from DE (weight: NA). The patient was diagnosed with: heart rate increased and Bisoprolol-ct 5 Mg was administered (dosage: NA) starting: NS. The consumer developed a set of symptoms:
  • Vaginal Haemorrhage
Other drugs used simultaneously: NA.Those unexpected symptoms could be linked to a Bisoprolol-ct 5 Mg treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Product Quality Issue, Product Substitution Issue
This is a report of a possible correlation between Bisoprolol use and the following symptoms/side effect(s):
  • Product Quality Issue
  • Product Substitution Issue
which could contribute to an assessment of Bisoprolol risk profile.A 56-year-old female consumer from US (weight: NA) was suffering from blood pressure and was treated with Bisoprolol (dosage: NA) starting Aug 20, 2013.Other concurrent medications: NA.

Cardiac Fibrillation, Pulmonary Oedema
A 65-year-old female patient from US (weight: NA) presented with the following symptoms: cardiac fibrillation,off label use and after a treatment with Bisoprolol Fumarate Tablets (dosage: NA) experienced the following side effect(s):
  • Cardiac Fibrillation
  • Pulmonary Oedema
The treatment was started on Jul 09, 2012. Bisoprolol Fumarate Tablets was used in combination with the following drugs: NA.The patient was hospitalized.This report could alert potential Bisoprolol Fumarate Tablets consumers.

Acute Myeloid Leukaemia, Neutropenia, Leukopenia
In this report, a 62-year-old male patient from COUNTRY NOT SPECIFIED (weight: NA) was affected by a possible Bisoprolol side effect.The patient was diagnosed with hypertension. After a treatment with Bisoprolol (dosage: 5 Mg, start date: Apr 18, 2001), the patient experienced the following side effect(s):
  • Acute Myeloid Leukaemia
  • Neutropenia
  • Leukopenia
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 Bisoprolol treatment.

Anaphylactic Reaction
This is a report of a 74-year-old female patient from AU (weight: NA), who used Bisoprolol (dosage: NA) for a treatment of NA. After starting a treatment on Jan 15, 2013, the patient experienced the following side effect(s):
  • Anaphylactic Reaction
The following drugs could possibly have interacted with the Bisoprolol treatment
  • Atorvastatin (atorvastatin)
  • Ramipril (ramipril)
Taken together, these observations suggest that a Bisoprolol treatment could be related to side effect(s), such as Anaphylactic Reaction.

Head Injury, Syncope
This head injury side effect was reported by a physician from IT. A 91-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA. The patient was prescribed Bisoprolol (dosage: 1 Dosage Forms, Total, Oral), which was started on Jun 01, 2013. Concurrently used drugs:
  • Norvasc (amlodipine Besilate)
  • Lorazepam (lorazepam)
  • Allopurinol
  • Propafenone (propafenone)
When starting to take Bisoprolol the consumer reported the following symptoms:
  • Head Injury
  • Syncope
The patient was hospitalized. These side effects may potentially be related to Bisoprolol.

Sedation
This is a Bisoprolol (bisoprolol) side effect report of a 62-year-old male patient (weight:NA) from GB, suffering from the following symptoms/conditions: NA, who was treated with Bisoprolol (bisoprolol) (dosage:NA, start time: NS), combined with:
  • Atorvastatin (atorvastatin)
  • Felodipine (felodipine)
  • Ramipril (ramipril)
, and developed a serious reaction and a sedation side effect. The patient presented with:
  • Sedation
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Bisoprolol (bisoprolol) treatment in male patients suffering from NA, resulting in sedation.

Sedation
This report suggests a potential Bisoprolol sedation side effect(s) that can have serious consequences. A 62-year-old male patient from GB (weight:NA) was diagnosed with the following health condition(s): NA and used Bisoprolol (dosage: NA) starting Jan 31, 2013. Soon after starting Bisoprolol the patient began experiencing various side effects, including:
  • Sedation
Drugs used concurrently:
  • Atorvastatin
  • Felodipine
  • Ramipril
Although Bisoprolol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as sedation, may still occur.

Syncope, Head Injury
This syncope problem was reported by a physician from IT. A 91-year-old male patient (weight: NA) was diagnosed with the following medical condition(s): NA.On Jun 01, 2013 a consumer started treatment with Bisoprolol (dosage: NA). The following drugs/medications were being taken at the same time:
  • Norvasc
  • Lorazepam
  • Allopurinol
  • Propafenone
When commencing Bisoprolol, the patient experienced the following unwanted symptoms /side effects:
  • Syncope
  • Head Injury
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 syncope, may become evident only after a product is in use by the general population.

Syncope, Ventricular Extrasystoles, Tachycardia
This is a Bisoprolol side effect report of a 89-year-old male patient (weight: NA) from FR. The patient developed the following symptoms/conditions: NA and was treated with Bisoprolol (dosage: NA) starting May 31, 2013. Concurrently used drugs:
  • Leponex
  • Exelon
  • Sinemet
  • Mecir
  • Movicol
  • Inexium
  • Kardegic
  • Adancor
Soon after that, the consumer experienced the following of symptoms:
  • Syncope
  • Ventricular Extrasystoles
  • Tachycardia
This opens a possibility that Bisoprolol could cause syncope and that some male patients may be more susceptible.

Cerebral Ischaemia, Encephalitis, Dysgeusia, Hyposmia, Hypogeusia, Parosmia
A 58-year-old female patient (weight: NA) from DE with the following symptoms: hypertension,hypothyroidism started Bisoprolol treatment (dosage: NA) on Aug 01, 2012. Soon after starting Bisoprolol treatment, the consumer experienced several side effects, including:
  • Cerebral Ischaemia
  • Encephalitis
  • Dysgeusia
  • Hyposmia
  • Hypogeusia
  • Parosmia
. Concurrently used drugs:
  • L-thyroxin
  • Valsartan
This finding indicates that some patients can be more vulnerable to developing Bisoprolol side effects, such as cerebral ischaemia.

International Normalised Ratio Increased, Urinary Tract Infection, Overdose, Dehydration, Cognitive Disorder, Hyponatraemia, Somnolence, Hypokalaemia
This international normalised ratio increased side effect was reported by a health professional from FR. A 86-year-old female patient (weight:NA) experienced the following symptoms/conditions: hypertension,arrhythmia.The patient was prescribed Bisoprolol (bisoprolol) (dosage: NA), which was started on Jun 04, 2013. Concurrently used drugs:
  • Cordarone (amiodarone Hydrochloride)/oral/tablet/200 Milligrams(s) (5 Days A Week)
  • Candesartan Cilexetil (candesartan Cilexetil)
  • Furosemide (furosemide)
  • Amoxicillin (amoxicillin)
  • Previscan
  • Glucophage
  • Domperidone (domperidone)
  • Lansoprazole (lansoprazole)
.When starting to take Bisoprolol (bisoprolol) the consumer reported symptoms, such as:
  • International Normalised Ratio Increased
  • Urinary Tract Infection
  • Overdose
  • Dehydration
  • Cognitive Disorder
  • Hyponatraemia
  • Somnolence
  • Hypokalaemia
These side effects may potentially be related to Bisoprolol (bisoprolol). The patient was hospitalized.

Circulatory Collapse, Fall, Hand Fracture, Hypotension, Vomiting, Food Poisoning
This is a report of a 79-year-old female patient (weight: NA) from GB, suffering from the following symptoms/conditions: NA, who was treated with Bisoprolol (dosage: NA, start time: NS), combined with:
  • Ramipril
  • Asa
  • Atenolol
  • Simvastatin
  • Tamoxifen
  • Clopidogrel
and developed a serious reaction and side effect(s). The consumer presented with:
  • Circulatory Collapse
  • Fall
  • Hand Fracture
  • Hypotension
  • Vomiting
  • Food Poisoning
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Bisoprolol treatment in female patients, resulting in circulatory collapse side effect. The patient was hospitalized.

Sedation
This report suggests a potential Bisoprolol Sedation side effect(s) that can have serious consequences. A 62-year-old male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: NA and used Bisoprolol (dosage: NA) starting Mar 28, 2013. Soon after starting Bisoprolol the patient began experiencing various side effects, including:
  • Sedation
Drugs used concurrently:
  • Ramipril
  • Felodipine
  • Atorvastatin
Although Bisoprolol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as sedation, may still occur.

Circulatory Collapse
This Circulatory Collapse problem was reported by a physician from GB. A 79-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Bisoprolol (dosage: NA). The following drugs were being taken at the same time:
  • Ramipril
  • Asa
  • Atenolol
  • Simvastatin
  • Tamoxifen
When commencing Bisoprolol, the patient experienced the following unwanted symptoms/side effects:
  • Circulatory Collapse
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 circulatory collapse, may become evident only after a product is in use by the general population.

Sedation
This is a report of a 62-year-old male patient (weight: NA) from GB. The patient developed the following symptoms/conditions: NA and was treated with Bisoprolol (dosage: NA) starting Mar 28, 2013. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Sedation
This opens a possibility that Bisoprolol treatment could cause the above reactions, including sedation, and some male subjects may be more susceptible.

Circulatory Collapse, Fall, Vomiting, Fracture, Dizziness, Hypotension, Hand Fracture, Food Poisoning
A 79-year-old female patient (weight: NA) from GB with the following symptoms/conditions: NA started Bisoprolol treatment (dosage: NA) on NS. Soon after starting Bisoprolol treatment, the subject experienced various side effects, including:
  • Circulatory Collapse
  • Fall
  • Vomiting
  • Fracture
  • Dizziness
  • Hypotension
  • Hand Fracture
  • Food Poisoning
Concurrently used drugs:
  • Ramipril
  • Atenolol (atenolol)
  • Simvastatin (simvastatin)
  • Tamoxifen
  • Asa (acetylsalicylic Acid)
The patient was hospitalized. This finding indicates that some female patients could be more vulnerable to Bisoprolol.

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Top 10 Bisoprolol Side Effects for Women

Women Side EffectsReports
Bradycardia 90
Fall 63
Dizziness 59
Hypotension 55
Malaise 54
Dyspnoea 52
Renal Failure Acute 51
Syncope 49
Nausea 46
Loss Of Consciousness 38

Top 10 Bisoprolol Side Effects for Men

Men Side EffectsReports
Dyspnoea 52
Bradycardia 51
Atrial Fibrillation 42
Renal Failure Acute 40
Hyperkalaemia 35
Hypotension 33
Syncope 33
Fatigue 32
Diarrhoea 31
Dizziness 30

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 Bisoprolol Side Effects

    Did You Have a Bisoprolol Side Effect?

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    How Effective is Bisoprolol for You?

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    Bisoprolol Safety Alerts, Active Ingredients, Usage Information

    NDC0093-5270
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameBisoprolol Fumarate
    NameBisoprolol Fumarate
    Dosage FormTABLET, FILM COATED
    RouteORAL
    On market since20040601
    LabelerTeva Pharmaceuticals USA Inc
    Active Ingredient(s)BISOPROLOL FUMARATE
    Strength(s)5
    Unit(s)mg/1
    Pharma ClassAdrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]

    More About Bisoprolol

    Side Effects reported to FDA: 1787

    Bisoprolol safety alerts: No

    Reported deaths: 92

    Reported hospitalizations: 680

    Latest Bisoprolol clinical trials