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Bicor Side Effects

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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.

Bicor Side Effects Reported to FDA



Bicor Side Effect Report#8077566-6
Pulmonary Fibrosis
This is a report of a male patient (weight: NA) from Australia, suffering from the following health 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): Pulmonary Fibrosis 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.
Bicor Side Effect Report#7831571-0
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. After starting Bicor the patient began experiencing various side effects, including: Cardiac ArrestAdditional 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.
Bicor Side Effect Report#7744130-5
Implantable Defibrillator Replacement, Pain In Extremity, Glaucoma, Cataract, Neck Pain, Contusion, Myocardial Infarction
This Implantable Defibrillator Replacement 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 using Bicor, the patient experienced the following unwanted symptoms/side effects: Implantable Defibrillator Replacement, Pain In Extremity, Glaucoma, Cataract, Neck Pain, Contusion, Myocardial InfarctionThe 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.
Bicor Side Effect Report#6121843-2
Abnormal Dreams, Cough, Loss Of Consciousness
This Abnormal Dreams side effect was reported by a consumer or non-health professional from Australia. A 68-year-old female patient (weight:NA) experienced the following symptoms/conditions: cardiomyopathy.The patient was prescribed Bicor (bisoprolol) (5 Mg) (drug dosage: 5 Mg; Daily; Oral), which was initiated on
Jan 27, 2009. Concurrently used drugs:
  • Zestril
  • Somac
  • Propyl-thiouracil
  • Cartia Xt
  • Caltrate
  • Fish Oil
  • Glucosamine
  • Vitamin B Complex Cap
.After starting to take Bicor (bisoprolol) (5 Mg) the consumer reported adverse symptoms, such as: Abnormal Dreams, Cough, Loss Of ConsciousnessThese side effects may potentially be related to Bicor (bisoprolol) (5 Mg).
Bicor Side Effect Report#5901791-0
Decreased Activity, Depression, Dyspnoea Exertional, Fatigue, Irritability, Memory Impairment, Mental Impairment, Weight Increased
This is a report of a 82-year-old male patient (weight: NA) from Australia, suffering from the following health symptoms/conditions: atrial flutter, who was treated with Bicor (tablet) (bisoprolol Fumarate) (dosage: See Image, start time:
Jan 01, 2006), combined with:
  • Warfarin Sodium
  • Aloactone (spironolactone)
  • Ramipril
  • Uremide (furosemide)
and developed a serious reaction and side effect(s): Decreased Activity, Depression, Dyspnoea Exertional, Fatigue, Irritability, Memory Impairment, Mental Impairment, Weight Increased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Bicor (tablet) (bisoprolol Fumarate) treatment in male patients, resulting in Decreased Activity side effect.
Bicor Side Effect Report#5897883-5
Anxiety, Depression, Dizziness, Headache, Hearing Impaired, Insomnia, Irritability, Personality Change, Tearfulness
This report suggests a potential Bicor (bisoprolol Fumarate) Anxiety side effect(s) that can have serious consequences. A 34-year-old female patient (weight: NA) from Australia was diagnosed with the following symptoms/conditions: left ventricular failure and used 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) starting
Mar 18, 2008. After starting Bicor (bisoprolol Fumarate) the patient began experiencing various side effects, including: Anxiety, Depression, Dizziness, Headache, Hearing Impaired, Insomnia, Irritability, Personality Change, TearfulnessAdditional drugs used concurrently:
  • 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
Although Bicor (bisoprolol Fumarate) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Anxiety, may still occur.
Bicor Side Effect Report#5818328-7
Balance Disorder, Decreased Appetite, Depression, Fatigue, Gait Disturbance, Rhinorrhoea, Vision Blurred, Weight Decreased
This Balance Disorder problem was reported by a consumer or non-health professional from Australia. A 79-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: congestive cardiomyopathy,heart rate irregular. On
Dec 27, 2007 this consumer started treatment with Bicor (10 Mg, Tablet) (bisoprolol Fumarate) (dosage: 10 Mg (10 Mg, 1 In 1 D) Oral). The following drugs were being taken at the same time: NA. When using Bicor (10 Mg, Tablet) (bisoprolol Fumarate), the patient experienced the following unwanted symptoms/side effects: Balance Disorder, Decreased Appetite, Depression, Fatigue, Gait Disturbance, Rhinorrhoea, Vision Blurred, Weight DecreasedAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Balance Disorder, may become evident only after a product is in use by the general population.
Bicor Side Effect Report#5817411-X
Balance Disorder, Decreased Appetite, Depression, Fatigue, Gait Disturbance, Rhinorrhoea, Vision Blurred, Weight Decreased
This Balance Disorder side effect was reported by a consumer or non-health professional from Australia. A 79-year-old female patient (weight:NA) experienced the following symptoms/conditions: heart rate irregular.The patient was prescribed Bicor(10 Mg, Tablet) (bisoprolol Fumarate) (drug dosage: 10 Mg, (10 Mg, 1 In 1 D); Oral), which was initiated on
Dec 27, 2007. Concurrently used drugs:
  • Coversyl (peridopril)
  • Warfarin Sodium
  • Lanoxin
.After starting to take Bicor(10 Mg, Tablet) (bisoprolol Fumarate) the consumer reported adverse symptoms, such as: Balance Disorder, Decreased Appetite, Depression, Fatigue, Gait Disturbance, Rhinorrhoea, Vision Blurred, Weight DecreasedThese side effects may potentially be related to Bicor(10 Mg, Tablet) (bisoprolol Fumarate).
Bicor Side Effect Report#5800582-9
Eye Pruritus, Fatigue, Hypoacusis, Insomnia, Pallor, Peripheral Coldness, Pruritus, Sleep Disorder
This is a report of a 75-year-old male patient (weight: NA) from Australia, suffering from the following health symptoms/conditions: cardiac disorder, who was treated with Bicor (tablet) (bisoprolol Fumarate) (dosage: 5 Mg (5 Mg, 1 In 1 D); Oral, start time:
May 06, 2008), combined with:
  • Karvezide (hydrochlorothiazide, Irbesartan)
  • Vytorin
  • Aspirin
  • Macuvision
and developed a serious reaction and side effect(s): Eye Pruritus, Fatigue, Hypoacusis, Insomnia, Pallor, Peripheral Coldness, Pruritus, Sleep Disorder after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Bicor (tablet) (bisoprolol Fumarate) treatment in male patients, resulting in Eye Pruritus side effect.
Bicor Side Effect Report#5744918-6
Aggression, Anxiety, Depression, Dizziness, Headache, Hearing Impaired, Insomnia, Irritability, Personality Change
This report suggests a potential Bicor /00802602/ (bisoprolol Fumarate) Aggression side effect(s) that can have serious consequences. A 34-year-old female patient (weight: NA) from Australia was diagnosed with the following symptoms/conditions: left ventricular failure and used Bicor /00802602/ (bisoprolol Fumarate) (dosage: 1.25 Mg; Daily; Oral, 2.5 Mg; Daily; Oral, 1.25 Mg; Daily; Oral) starting
Mar 18, 2008. After starting Bicor /00802602/ (bisoprolol Fumarate) the patient began experiencing various side effects, including: Aggression, Anxiety, Depression, Dizziness, Headache, Hearing Impaired, Insomnia, Irritability, Personality ChangeAdditional drugs used concurrently: NA. Although Bicor /00802602/ (bisoprolol Fumarate) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Aggression, may still occur.
Bicor Side Effect Report#5506225-6
Amnesia, Depression, Dyspnoea Exertional, Exercise Tolerance Decreased, Fatigue, Irritability, Memory Impairment, Mental Impairment, Weight Increased
This Amnesia problem was reported by a consumer or non-health professional from . A 82-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: atrial flutter. On
Oct 31, 2007 this consumer started treatment with Bicor /00802602/ (bisoprolol Fumarate) (dosage: ;daily;oral 5 Mg;daily;oral; 10 Mg;daily;oral; 5mg;every Other Day;oral). The following drugs were being taken at the same time: NA. When using Bicor /00802602/ (bisoprolol Fumarate), the patient experienced the following unwanted symptoms/side effects: Amnesia, Depression, Dyspnoea Exertional, Exercise Tolerance Decreased, Fatigue, Irritability, Memory Impairment, Mental Impairment, Weight IncreasedAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Amnesia, may become evident only after a product is in use by the general population.
Bicor Side Effect Report#10036437
Rash, Rash Erythematous, Glomerular Filtration Rate Decreased
This Rash side effect was reported by a consumer or non-health professional from AU. A 82-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Bicor (drug dosage: NA), which was initiated on 201307. Concurrently used drugs:
  • Amiodarone
  • Lasix
  • Crestor
  • Coversyl
.After starting to take Bicor the consumer reported adverse symptoms, such as: Rash, Rash Erythematous, Glomerular Filtration Rate DecreasedThese side effects may potentially be related to Bicor.



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.

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What are common Bicor Side Effects for Women?

Women Side EffectsReports
Depression 4
Anxiety 2
Balance Disorder 2
Decreased Appetite 2
Dizziness 2
Fatigue 2
Gait Disturbance 2
Headache 2
Hearing Impaired 2
Insomnia 2

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health 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

    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.

    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.

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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