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Bicor Side Effects

Common Bicor Side Effects


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

Depression (6)
Fatigue (5)
Irritability (4)
Insomnia (3)
Balance Disorder (2)
Decreased Appetite (2)
Anxiety (2)
Dyspnoea Exertional (2)
Gait Disturbance (2)
Headache (2)
Dizziness (2)
Weight Increased (2)
Personality Change (2)
Mental Impairment (2)
Rhinorrhoea (2)
Vision Blurred (2)
Memory Impairment (2)
Weight Decreased (2)
Hearing Impaired (2)
Loss Of Consciousness (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.

Bicor Side Effects Reported to FDA

The following Bicor 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 Bicor 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.
Pulmonary Fibrosis
This is a report of a male patient (weight: NA) from AUSTRALIA, suffering from the following symptoms/conditions: NA, who was treated with Bicor (dosage: NA, start time: Jul 11, 2011), combined with:
  • Zocor
  • Nsaid
  • Pradaxa
  • Pradaxa
  • Digoxin
and developed a serious reaction and side effect(s). The consumer presented with:
  • Pulmonary Fibrosis
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Bicor treatment in male patients, resulting in pulmonary fibrosis side effect.

Cardiac Arrest
This report suggests a potential Bicor Cardiac Arrest side effect(s) that can have serious consequences. A female patient (weight: NA) from AUSTRALIA was diagnosed with the following symptoms/conditions: NA and used Bicor (dosage: 1.25 Mg) starting Aug 07, 2011. Soon after starting Bicor the patient began experiencing various side effects, including:
  • Cardiac Arrest
Drugs used concurrently:
  • Pradaxa (220 Mg)
  • Lipitor (20 Mg)
Although Bicor demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as cardiac arrest, may still occur.

Implantable Defibrillator Replacement, Pain In Extremity, Glaucoma, Cataract, Neck Pain, Contusion, Myocardial Infarction
This Implantable Defibrillator Replacement, Pain In Extremity, Glaucoma, Cataract, Neck Pain, Contusion, Myocardial Infarction problem was reported by a consumer or non-health professional from AUSTRALIA. A 75-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On Dec 31, 1999 this consumer started treatment with Bicor (dosage: NA). The following drugs were being taken at the same time:
  • Lasix
  • Crestor
  • Pantoprazole
  • Magnesium
  • Lisinopril
  • Lantus
  • Plavix
  • Acetylsalicylic Acid Srt
When commencing Bicor, the patient experienced the following unwanted symptoms/side effects:
  • Implantable Defibrillator Replacement
  • Pain In Extremity
  • Glaucoma
  • Cataract
  • Neck Pain
  • Contusion
  • Myocardial Infarction
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 implantable defibrillator replacement, may become evident only after a product is in use by the general population.

Abnormal Dreams, Cough, Loss Of Consciousness
This is a report of a 68-year-old female patient (weight: NA) from AUSTRALIA. The patient developed the following symptoms/conditions: cardiomyopathy and was treated with Bicor (bisoprolol) (5 Mg) (dosage: 5 Mg; Daily; Oral) starting Jan 27, 2009. Concurrently used drugs:
  • Zestril
  • Somac
  • Propyl-thiouracil
  • Cartia Xt
  • Caltrate
  • Fish Oil
  • Glucosamine
  • Vitamin B Complex Cap
Soon after that, the consumer experienced the following side effects:
  • Abnormal Dreams
  • Cough
  • Loss Of Consciousness
This opens a possibility that Bicor (bisoprolol) (5 Mg) treatment could cause the above reactions, including abnormal dreams, and some female subjects may be more susceptible.


Decreased Activity, Depression, Dyspnoea Exertional, Fatigue, Irritability, Memory Impairment, Mental Impairment, Weight Increased
A 82-year-old male patient (weight: NA) from AUSTRALIA with the following symptoms/conditions: atrial flutter started Bicor (tablet) (bisoprolol Fumarate) treatment (dosage: See Image) on Jan 01, 2006. Soon after starting Bicor (tablet) (bisoprolol Fumarate) treatment, the subject experienced various side effects, including:
  • Decreased Activity
  • Depression
  • Dyspnoea Exertional
  • Fatigue
  • Irritability
  • Memory Impairment
  • Mental Impairment
  • Weight Increased
Concurrently used drugs:
  • Warfarin Sodium
  • Aloactone (spironolactone)
  • Ramipril
  • Uremide (furosemide)
This finding indicates that some male patients could be more vulnerable to Bicor (tablet) (bisoprolol Fumarate).

Anxiety, Depression, Dizziness, Headache, Hearing Impaired, Insomnia, Irritability, Personality Change, Tearfulness
A 34-year-old female patient from AUSTRALIA (weight: NA) experienced symptoms, such as: left ventricular failure and was treated with Bicor (bisoprolol Fumarate)(dosage: 1.25 Mg (1.25 Mg, 1 In 1 D) Oral; 2.5 Mg (2.5 Mg, 1 In 1 D) Oral). The treatment was initiated on Mar 18, 2008. After that a consumer reported the following side effect(s):
  • Anxiety
  • Depression
  • Dizziness
  • Headache
  • Hearing Impaired
  • Insomnia
  • Irritability
  • Personality Change
  • Tearfulness
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Bicor (bisoprolol Fumarate) efficacy:
  • Bicor (bisoprolol Fumarate) (1.25 Mg (1.25 Mg, 1 In 1 D) Oral; 2.5 Mg (2.5 Mg, 1 In 1 D) Oral)
  • Bicor (bisoprolol Fumarate) (1.25 Mg (1.25 Mg, 1 In 1 D) Oral; 2.5 Mg (2.5 Mg, 1 In 1 D) Oral)
  • Nitrazepam
  • Spiriva


Balance Disorder, Decreased Appetite, Depression, Fatigue, Gait Disturbance, Rhinorrhoea, Vision Blurred, Weight Decreased
In this report, Bicor (10 Mg, Tablet) (bisoprolol Fumarate) was administered for the following condition: congestive cardiomyopathy,heart rate irregular.A 79-year-old female consumer from AUSTRALIA (weight: NA) started Bicor (10 Mg, Tablet) (bisoprolol Fumarate) treatment (dosage: 10 Mg (10 Mg, 1 In 1 D) Oral) on Dec 27, 2007.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Balance Disorder
  • Decreased Appetite
  • Depression
  • Fatigue
  • Gait Disturbance
  • Rhinorrhoea
  • Vision Blurred
  • Weight Decreased
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 Bicor (10 Mg, Tablet) (bisoprolol Fumarate) treatment could be related to the listed above side effect(s).

Balance Disorder, Decreased Appetite, Depression, Fatigue, Gait Disturbance, Rhinorrhoea, Vision Blurred, Weight Decreased
This is a report of the following Bicor(10 Mg, Tablet) (bisoprolol Fumarate) side effect(s):
  • Balance Disorder
  • Decreased Appetite
  • Depression
  • Fatigue
  • Gait Disturbance
  • Rhinorrhoea
  • Vision Blurred
  • Weight Decreased
A 79-year-old female patient from AUSTRALIA (weight: NA) presented with the following condition: heart rate irregular and received a treatment with Bicor(10 Mg, Tablet) (bisoprolol Fumarate) (dosage: 10 Mg, (10 Mg, 1 In 1 D); Oral) starting: Dec 27, 2007.The following concurrently used drugs could have generated interactions:
  • Coversyl (peridopril)
  • Warfarin Sodium
  • Lanoxin
This report suggests that a Bicor(10 Mg, Tablet) (bisoprolol Fumarate) treatment could be associated with the listed above side effect(s).

Eye Pruritus, Fatigue, Hypoacusis, Insomnia, Pallor, Peripheral Coldness, Sleep Disorder
This Bicor (tablet) (bisoprolol Fumarate) report was submitted by a 75-year-old male consumer from AUSTRALIA (weight: NA). The patient was diagnosed with: cardiac disorder and Bicor (tablet) (bisoprolol Fumarate) was administered (dosage: 5 Mg (5 Mg, 1 In 1 D); Oral) starting: May 06, 2008. The consumer developed a set of symptoms:
  • Eye Pruritus
  • Fatigue
  • Hypoacusis
  • Insomnia
  • Pallor
  • Peripheral Coldness
  • Sleep Disorder
Other drugs used simultaneously:
  • Karvezide (hydrochlorothiazide, Irbesartan)
  • Vytorin
  • Aspirin
  • Macuvision
Those unexpected symptoms could be linked to a Bicor (tablet) (bisoprolol Fumarate) treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Aggression, Anxiety, Depression, Dizziness, Headache, Hearing Impaired, Insomnia, Irritability, Personality Change
This is a report of a possible correlation between Bicor /00802602/ (bisoprolol Fumarate) use and the following symptoms/side effect(s):
  • Aggression
  • Anxiety
  • Depression
  • Dizziness
  • Headache
  • Hearing Impaired
  • Insomnia
  • Irritability
  • Personality Change
which could contribute to an assessment of Bicor /00802602/ (bisoprolol Fumarate) risk profile.A 34-year-old female consumer from AUSTRALIA (weight: NA) was suffering from left ventricular failure and was treated with Bicor /00802602/ (bisoprolol Fumarate) (dosage: 1.25 Mg; Daily; Oral, 2.5 Mg; Daily; Oral, 1.25 Mg; Daily; Oral) starting Mar 18, 2008.Other concurrent medications: NA.

Amnesia, Depression, Dyspnoea Exertional, Exercise Tolerance Decreased, Fatigue, Irritability, Memory Impairment, Mental Impairment, Weight Increased
A 82-year-old male patient from (weight: NA) presented with the following symptoms: atrial flutter and after a treatment with Bicor /00802602/ (bisoprolol Fumarate) (dosage: ;daily;oral 5 Mg;daily;oral; 10 Mg;daily;oral; 5mg;every Other Day;oral) experienced the following side effect(s):
  • Amnesia
  • Depression
  • Dyspnoea Exertional
  • Exercise Tolerance Decreased
  • Fatigue
  • Irritability
  • Memory Impairment
  • Mental Impairment
  • Weight Increased
The treatment was started on Oct 31, 2007. Bicor /00802602/ (bisoprolol Fumarate) was used in combination with the following drugs: NA.This report could alert potential Bicor /00802602/ (bisoprolol Fumarate) consumers.

Rash, Rash Erythematous, Glomerular Filtration Rate Decreased
In this report, a 82-year-old female patient from AU (weight: NA) was affected by a possible Bicor side effect.The patient was diagnosed with NA. After a treatment with Bicor (dosage: NA, start date: 201307), the patient experienced the following side effect(s):
  • Rash
  • Rash Erythematous
  • Glomerular Filtration Rate Decreased
The following simultaneously used drugs could have led to this reaction:
  • Amiodarone
  • Lasix
  • Crestor
  • Coversyl
The findings here stress that side effects should be taken into consideration when evaluating a Bicor treatment.



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.


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    Bicor Safety Alerts, Active Ingredients, Usage Information

    NDC0186-0370
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameSYMBICORT
    NameBudesonide and Formoterol Fumarate Dihydrate
    Dosage FormAEROSOL
    RouteRESPIRATORY (INHALATION)
    On market since20070529
    LabelerAstraZeneca LP
    Active Ingredient(s)BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE
    Strength(s)160; 4.5
    Unit(s)ug/1; ug/1
    Pharma ClassCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Adrenergic beta2-Agonists [MoA],

    More About Bicor

    Side Effects reported to FDA: 12

    Bicor safety alerts: No

    Reported deaths: 2

    Reported hospitalizations: 1

    Latest Bicor clinical trials