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Betahistine Side Effects

Common Betahistine Side Effects


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

Liver Function Test Abnormal (4)
Myositis (3)
Dizziness (3)
Cholestasis (3)
Hyponatraemia (2)
Leukoencephalopathy (2)
Headache (2)
Malaise (2)
Syncope (2)
Myalgia (2)
Platelet Count Increased (1)
Muscular Weakness (1)
Movement Disorder (1)
Peptic Ulcer (1)
Muscle Spasms (1)
Oedema Peripheral (1)
Nasal Cavity Packing (1)
Nervous System Disorder (1)
Neutrophil Count Increased (1)
Pain (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.

Betahistine Side Effects Reported to FDA

The following Betahistine 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 Betahistine 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.
Aortic Aneurysm, Gastrointestinal Haemorrhage, Peptic Ulcer, Type 2 Diabetes Mellitus
This is a report of a 70-year-old male patient (weight: NA) from GB, suffering from the following symptoms/conditions: vertigo, who was treated with Betahistine (dosage: NA, start time: Jun 29, 2009), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Aortic Aneurysm
  • Gastrointestinal Haemorrhage
  • Peptic Ulcer
  • Type 2 Diabetes Mellitus
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Betahistine treatment in male patients, resulting in aortic aneurysm side effect. The patient was hospitalized.

Nasal Cavity Packing, Epistaxis
This report suggests a potential Betahistine Nasal Cavity Packing, Epistaxis side effect(s) that can have serious consequences. A 86-year-old female patient (weight: NA) from UNITED KINGDOM was diagnosed with the following symptoms/conditions: dizziness,ulcer,rhinitis,heart valve replacement and used Betahistine (dosage: 48mg Per Day) starting May 01, 2011. Soon after starting Betahistine the patient began experiencing various side effects, including:
  • Nasal Cavity Packing
  • Epistaxis
Drugs used concurrently:
  • Ranitidine (300mg Per Day)
  • Beconase (4iuax Per Day)
  • Clopidogrel (75mg Per Day)
The patient was hospitalized. Although Betahistine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as nasal cavity packing, may still occur.

Irritability, Dizziness, Disorientation, Speech Disorder, Vertigo, Confusional State
This Irritability, Dizziness, Disorientation, Speech Disorder, Vertigo, Confusional State problem was reported by a pharmacist from PORTUGAL. A 50-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: balance disorder,depression. On Jan 03, 2012 this consumer started treatment with Betahistine Hydrochloride (dosage: 16 Mg, 2x/day). The following drugs were being taken at the same time:
  • Bupropion Hydrochloride (150 Mg, 1x/day)
  • Lyrica (100 Mg, 3x/day)
When commencing Betahistine Hydrochloride, the patient experienced the following unwanted symptoms/side effects:
  • Irritability
  • Dizziness
  • Disorientation
  • Speech Disorder
  • Vertigo
  • Confusional State
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as irritability, may become evident only after a product is in use by the general population.

Convulsion, Drop Attacks
This is a report of a 67-year-old male patient (weight: NA) from UNITED KINGDOM. The patient developed the following symptoms/conditions: NA and was treated with Betahistine (dosage: NA) starting Apr 26, 2012. Concurrently used drugs:
  • Atorvastatin Calcium
  • Calcichew D3
  • Lamotrigine
  • Fluticasone Propionate/salmeterol
  • Citalopram Hydrobromide
  • Acetaminophen
  • Omeprazole
  • Aspirin
Soon after that, the consumer experienced the following side effects:
  • Convulsion
  • Drop Attacks
This opens a possibility that Betahistine treatment could cause the above reactions, including convulsion, and some male subjects may be more susceptible.


Self-injurious Ideation, Violence-related Symptom, Thinking Abnormal
A 47-year-old female patient (weight: NA) from UNITED KINGDOM with the following symptoms/conditions: NA started Betahistine treatment (dosage: NA) on Jan 05, 2012. Soon after starting Betahistine treatment, the subject experienced various side effects, including:
  • Self-injurious Ideation
  • Violence-related Symptom
  • Thinking Abnormal
Concurrently used drugs:
  • Gaviscon
  • Lansoprazole
  • Pregabalin
  • Cetirizine
  • Tramadol Hcl
  • Candesartan Cilexetil
  • Acetaminophen And Codeine Phosphate
  • Acetaminophen
This finding indicates that some female patients could be more vulnerable to Betahistine.

Syncope, Vomiting, Loss Of Consciousness, Dizziness
A female patient from UNITED KINGDOM (weight: NA) experienced symptoms, such as: NA and was treated with Betahistine(dosage: Prior To 2006). The treatment was initiated on Dec 04, 2009. After that a consumer reported the following side effect(s):
  • Syncope
  • Vomiting
  • Loss Of Consciousness
  • Dizziness
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Betahistine efficacy:
  • Fybogel (Form: Sachet; Dose: 1 Satchet Daily)
  • Mabthera (Form: Vial; Batch No.: B6042 For 500 Mg Vial; Batch No.: B6007 For 100 Mg Vial)
  • Proclorperazina
  • Mabthera
  • Chlorambucil (Per Protocol: 10 Mg/m2/day P.o. Days 1-7, Permanently Discontinued.)
  • Mabthera (Permanently Discontinued.)
  • Aspirin
  • Omeprazole
The patient was hospitalized.

Cerebral Ischaemia
In this report, Betahistine Hydrochloride was administered for the following condition: prophylaxis,metastatic renal cell carcinoma,nutritional support.A 81-year-old female consumer from CHINA (weight: NA) started Betahistine Hydrochloride treatment (dosage: 8 Mg, 3x/day) on Dec 29, 2010.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Cerebral Ischaemia
A possible interaction with other drugs could have contributed to this reaction:
  • Axitinib (3 Mg, 2x/day)
  • Vitamin E (268 Mg, 1x/day)
  • Ascorbic Acid (100 Mg, 1x/day)
  • Vitamin B6 (10 Mg, 1x/day)
Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Betahistine Hydrochloride treatment could be related to the listed above side effect(s).

Blood Bilirubin Increased, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Liver Function Test Abnormal, Renal Impairment
This is a report of the following Betahistine Mesilate side effect(s):
  • Blood Bilirubin Increased
  • Alanine Aminotransferase Increased
  • Aspartate Aminotransferase Increased
  • Liver Function Test Abnormal
  • Renal Impairment
A female patient from GERMANY (weight: NA) presented with the following condition: NA and received a treatment with Betahistine Mesilate (dosage: NA) starting: Dec 18, 2011.The following concurrently used drugs could have generated interactions:
  • Xarelto
  • Marcumar
  • Micardis
  • Lercanidipine
  • Heparin
The patient was hospitalized.This report suggests that a Betahistine Mesilate treatment could be associated with the listed above side effect(s).

Malaise, Chest Pain, Dyspepsia, Abdominal Pain Upper, Dizziness, Alopecia, Sleep Disorder, Muscle Spasms, Vision Blurred
This Betahistine report was submitted by a 50-year-old female consumer from NETHERLANDS (weight: NA). The patient was diagnosed with: NA and Betahistine was administered (dosage: NA) starting: Feb 21, 2011. The consumer developed a set of symptoms:
  • Malaise
  • Chest Pain
  • Dyspepsia
  • Abdominal Pain Upper
  • Dizziness
  • Alopecia
  • Sleep Disorder
  • Muscle Spasms
  • Vision Blurred
Other drugs used simultaneously:
  • Alendronate Sodium (1 Tablet Per Dag)
Those unexpected symptoms could be linked to a Betahistine treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Dyspnoea, Labyrinthitis, Oedema Peripheral
This is a report of a possible correlation between Betahistine (betahistine) (betahistine) use and the following symptoms/side effect(s):
  • Dyspnoea
  • Labyrinthitis
  • Oedema Peripheral
which could contribute to an assessment of Betahistine (betahistine) (betahistine) risk profile.A 51-year-old female consumer from BRAZIL (weight: NA) was suffering from NA and was treated with Betahistine (betahistine) (betahistine) (dosage: NA) starting Jan 01, 2011.Other concurrent medications:
  • Benicar Hct (20/12.5 Mg (1 In 1 D), Per Oral)
The patient was hospitalized.

Sinusitis, Feeling Abnormal, Gait Disturbance, Brain Hypoxia, Nervous System Disorder, Cerebrovascular Insufficiency
A 46-year-old female patient from BRAZIL (weight: NA) presented with the following symptoms: cerebrovascular disorder and after a treatment with Betahistine Dihydrochloride (dosage: 1 Df, Daily) experienced the following side effect(s):
  • Sinusitis
  • Feeling Abnormal
  • Gait Disturbance
  • Brain Hypoxia
  • Nervous System Disorder
  • Cerebrovascular Insufficiency
The treatment was started on NS. Betahistine Dihydrochloride was used in combination with the following drugs:
  • Trileptal (300 Mg, Bid)
  • Antidepressants (Unk Ukn, Unk)
  • Hydrochlorothiazide (1 Df, Daily)
  • Enalapril Maleate (1 Df, Daily)
This report could alert potential Betahistine Dihydrochloride consumers.

Leukoencephalopathy
In this report, a 77-year-old female patient from BELGIUM (weight: NA) was affected by a possible Betahistine side effect.The patient was diagnosed with NA. After a treatment with Betahistine (dosage: NA, start date: Feb 15, 2001), the patient experienced the following side effect(s):
  • Leukoencephalopathy
The following simultaneously used drugs could have led to this reaction:
  • Methotrexate
  • Acetaminophen
  • Orencia (Last Admin: 15nov11.)
  • Strumazol
The findings here stress that side effects should be taken into consideration when evaluating a Betahistine treatment.

Transitional Cell Carcinoma
This is a report of a female patient from BELGIUM (weight: NA), who used Betahistine (dosage: NA) for a treatment of oesophagitis. After starting a treatment on Oct 11, 2011, the patient experienced the following side effect(s):
  • Transitional Cell Carcinoma
The following drugs could possibly have interacted with the Betahistine treatment
  • Levothyroxine Sodium
  • Michol
  • Pantoprazole
  • Revlimid (20 Milligram)
Taken together, these observations suggest that a Betahistine treatment could be related to side effect(s), such as Transitional Cell Carcinoma.

Encephalitis, Leukoencephalopathy
This encephalitis side effect was reported by a consumer or non-health professional from BELGIUM. A 77-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA. The patient was prescribed Betahistine (dosage: NA), which was started on Jan 01, 2000. Concurrently used drugs:
  • Orencia (Last Admin: 15nov11.)
  • Methotrexate
  • Strumazol
  • Acetaminophen
When starting to take Betahistine the consumer reported the following symptoms:
  • Encephalitis
  • Leukoencephalopathy
These side effects may potentially be related to Betahistine.

Large Intestine Perforation, Hepatic Congestion, Infectious Peritonitis, Platelet Count Increased, Constipation, Pain, Neutrophil Count Increased, Large Intestinal Obstruction
This is a Betahistine side effect report of a female patient (weight:NA) from UNITED KINGDOM, suffering from the following symptoms/conditions: NA, who was treated with Betahistine (dosage:1 Ukn, Tid, start time: Dec 08, 2003), combined with:
  • Metoclopramide (10 Mg, Tid)
  • Hyoscine Hydrobromide (150 Mg, Daily)
  • Nizatidine (150 Mg, At Night)
  • Clozaril (300 Mg, Bid)
  • Acetaminophen And Codeine Phosphate (2 Ukn, Tid)
, and developed a serious reaction and a large intestine perforation side effect. The patient presented with:
  • Large Intestine Perforation
  • Hepatic Congestion
  • Infectious Peritonitis
  • Platelet Count Increased
  • Constipation
  • Pain
  • Neutrophil Count Increased
  • Large Intestinal Obstruction
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Betahistine treatment in female patients suffering from NA, resulting in large intestine perforation.

Uveitis
This report suggests a potential Betahistine Dihydrochloride uveitis side effect(s) that can have serious consequences. A 77-year-old male patient from AUSTRALIA (weight:NA) was diagnosed with the following health condition(s): meniere's disease,hypertension and used Betahistine Dihydrochloride (dosage: 30 Ml, Unk) starting Jun 15, 2010. Soon after starting Betahistine Dihydrochloride the patient began experiencing various side effects, including:
  • Uveitis
Drugs used concurrently:
  • Ramipril (5 Mg, Unk)
  • Metoprolol Tartrate (100 Mg, Unk)
  • Denosumab (60 Mg, Q6mo)
  • Stemetil (5 Mg, Unk)
  • Lipitor (20 Mg, Unk)
  • Cefaclor
  • Aspirin (100 Mg, Unk)
  • Goserelin Acetate (10.8 Mg, Unk)
The patient was hospitalized. Although Betahistine Dihydrochloride demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as uveitis, may still occur.

Psoriasis
This psoriasis problem was reported by a pharmacist from FRANCE. A 54-year-old male patient (weight: NA) was diagnosed with the following medical condition(s): NA.On Jan 01, 2009 a consumer started treatment with Betahistine (dosage: NA). The following drugs/medications were being taken at the same time:
  • Hyzaar
When commencing Betahistine, the patient experienced the following unwanted symptoms /side effects:
  • Psoriasis
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 psoriasis, may become evident only after a product is in use by the general population.

Muscular Weakness, Malaise, Headache, Myalgia
This is a Betahistine side effect report of a 57-year-old female patient (weight: NA) from UNITED KINGDOM. The patient developed the following symptoms/conditions: NA and was treated with Betahistine (dosage: Unk) starting Oct 14, 2011. Concurrently used drugs:
  • Sodium Docusate (Unk)
  • Prochlorperazine (Unk)
  • Acetaminophen (Unk)
  • Prednisolone (20 Mg, Unk)
  • Albuterol Sulfate Autohaler (Unk)
  • Warfarin Sodium (Unk)
  • Fluticasone Propionate/salmeterol (Unk)
  • Senna (Unk)
Soon after that, the consumer experienced the following of symptoms:
  • Muscular Weakness
  • Malaise
  • Headache
  • Myalgia
The patient was hospitalized. This opens a possibility that Betahistine could cause muscular weakness and that some female patients may be more susceptible.

Liver Function Test Abnormal, Cholestasis, Myositis
A 83-year-old female patient (weight: NA) from UNITED KINGDOM with the following symptoms: NA started Betahistine treatment (dosage: NA) on Apr 01, 2011. Soon after starting Betahistine treatment, the consumer experienced several side effects, including:
  • Liver Function Test Abnormal
  • Cholestasis
  • Myositis
. Concurrently used drugs:
  • Nitroglycerin
  • Felodipine
  • Doxycycline
  • Doxycycline
  • Bumetanide
  • Clopidogrel
  • Fluoxetine
  • Isosorbide Mononitrate
The patient was hospitalized. This finding indicates that some patients can be more vulnerable to developing Betahistine side effects, such as liver function test abnormal.

Decreased Appetite, Balance Disorder, Movement Disorder, Fall, Hyponatraemia, Hypokalaemia, Asthenia
This decreased appetite side effect was reported by a health professional from FRANCE. A 85-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Betahistine Dihydrochloride (dosage: NA), which was started on NS. Concurrently used drugs:
  • Previscan
  • Alendronic Acid
  • Nicardipine Hcl
  • Diacerein
  • Amiodarone Hcl
  • Forlax
  • Stresam
  • Indapamide
.When starting to take Betahistine Dihydrochloride the consumer reported symptoms, such as:
  • Decreased Appetite
  • Balance Disorder
  • Movement Disorder
  • Fall
  • Hyponatraemia
  • Hypokalaemia
  • Asthenia
These side effects may potentially be related to Betahistine Dihydrochloride. The patient was hospitalized.

Anaemia Megaloblastic, Vitamin B12 Deficiency
This is a report of a 85-year-old female patient (weight: NA) from PORTUGAL, suffering from the following symptoms/conditions: NA, who was treated with Betahistine (dosage: Unk, start time: Mar 14, 2011), combined with:
  • Relmus (Unk)
  • Zurim (Unk)
  • Trausan (100 Mg, Unk)
  • Monoket (20 Mg, Unk)
  • Aspirin (Unk)
  • Tolvon (30 Mg, Unk)
  • Indapamide (Unk)
  • Ascorbic Acid/hesperidin Methyl Chalcone/ruscus Aculeatus (Unk)
and developed a serious reaction and side effect(s). The consumer presented with:
  • Anaemia Megaloblastic
  • Vitamin B12 Deficiency
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Betahistine treatment in female patients, resulting in anaemia megaloblastic side effect. The patient was hospitalized and became disabled.

Myositis, Liver Function Test Abnormal, Cholestasis
This report suggests a potential Betahistine Myositis, Liver Function Test Abnormal, Cholestasis side effect(s) that can have serious consequences. A 83-year-old female patient (weight: NA) from UNITED KINGDOM was diagnosed with the following symptoms/conditions: NA and used Betahistine (dosage: NA) starting Jun 27, 2011. Soon after starting Betahistine the patient began experiencing various side effects, including:
  • Myositis
  • Liver Function Test Abnormal
  • Cholestasis
Drugs used concurrently:
  • Omeprazole
  • Doxycycline
  • Fluoxetine
  • Isosorbide Mononitrate
  • Lactulose
  • Acetaminophen
  • Atorvastatin
  • Ramipril
The patient was hospitalized. Although Betahistine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as myositis, may still occur.

Cholestasis, Myositis, Blood Creatine Phosphokinase Increased, Liver Function Test Abnormal
This Cholestasis, Myositis, Blood Creatine Phosphokinase Increased, Liver Function Test Abnormal problem was reported by a health professional from UNITED KINGDOM. A 83-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On Apr 01, 2011 this consumer started treatment with Betahistine Hydrochloride (dosage: NA). The following drugs were being taken at the same time:
  • Bumetanide
  • Clopidogrel
  • Isosorbide Mononitrate
  • Omeprazole
  • Felodipine
  • Lactulose
  • Glyceryl Trinitrate
  • Doxycycline Hyclate (200 Mg, Single)
When commencing Betahistine Hydrochloride, the patient experienced the following unwanted symptoms/side effects:
  • Cholestasis
  • Myositis
  • Blood Creatine Phosphokinase Increased
  • Liver Function Test Abnormal
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 cholestasis, may become evident only after a product is in use by the general population.

Brain Herniation
This is a report of a male patient (weight: NA) from GERMANY. The patient developed the following symptoms/conditions: NA and was treated with Betahistine (dosage: NA) starting Aug 08, 2005. Concurrently used drugs:
  • Omeprazole
  • Amlodipine
  • Tasigna (400 Mg, Bid)
  • Prednisone
  • Enalapril Maleate
  • Hydrochlorothiazde Tab
  • Magnesium
Soon after that, the consumer experienced the following side effects:
  • Brain Herniation
The patient was hospitalized. This opens a possibility that Betahistine treatment could cause the above reactions, including brain herniation, and some male subjects may be more susceptible.

Stomatitis
A 67-year-old female patient (weight: NA) from GERMANY with the following symptoms/conditions: hypertension,osteoporosis,rheumatoid arthritis started Betahistine treatment (dosage: 24 Mg, Unk) on Jan 01, 2009. Soon after starting Betahistine treatment, the subject experienced various side effects, including:
  • Stomatitis
Concurrently used drugs:
  • Vitamin A (800 Iu, Unk)
  • Methotrexate (7.5 Mg, Unk)
  • Flunarizine (5 Mg, Unk)
  • Prednisolone (2.5 Mg, Unk)
  • Calcium Carbonate (1000 Mg, Unk)
  • Metoprolol Succinate (47.5 Mg, Unk)
  • Enbrel (50 Mg, Qwk)
  • Prednisolone (12.5 Mg, Unk)
This finding indicates that some female patients could be more vulnerable to Betahistine.

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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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    Side Effects reported to FDA: 29

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    Reported deaths: 2

    Reported hospitalizations: 10

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