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Betahistine Side Effects

PatientsVille

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.

Betahistine Side Effects Reported to FDA



Betahistine Side Effect Report#8902863
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 health 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): Aortic Aneurysm, Gastrointestinal Haemorrhage, Peptic Ulcer, Type 2 Diabetes Mellitus 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.
Betahistine Side Effect Report#8463007-3
Nasal Cavity Packing, Epistaxis
This report suggests a potential Betahistine Nasal Cavity Packing 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. After starting Betahistine the patient began experiencing various side effects, including: Nasal Cavity Packing, EpistaxisAdditional 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.
Betahistine Side Effect Report#8418426-8
Irritability, Dizziness, Disorientation, Speech Disorder, Vertigo, Confusional State
This Irritability 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 using Betahistine Hydrochloride, the patient experienced the following unwanted symptoms/side effects: Irritability, Dizziness, Disorientation, Speech Disorder, Vertigo, Confusional StateAlthough 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.
Betahistine Side Effect Report#8402281-6
Convulsion, Drop Attacks
This Convulsion side effect was reported by a physician from United Kingdom. A 67-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Betahistine (drug dosage: NA), which was initiated on
Apr 26, 2012. Concurrently used drugs:
  • Atorvastatin Calcium
  • Calcichew D3
  • Lamotrigine
  • Fluticasone Propionate/salmeterol
  • Citalopram Hydrobromide
  • Acetaminophen
  • Omeprazole
  • Aspirin
.After starting to take Betahistine the consumer reported adverse symptoms, such as: Convulsion, Drop AttacksThese side effects may potentially be related to Betahistine.
Betahistine Side Effect Report#8399807-8
Self-injurious Ideation, Violence-related Symptom, Thinking Abnormal
This is a report of a 47-year-old female patient (weight: NA) from United Kingdom, suffering from the following health symptoms/conditions: NA, who was treated with Betahistine (dosage: NA, start time:
Jan 05, 2012), combined with:
  • Gaviscon
  • Lansoprazole
  • Pregabalin
  • Cetirizine
  • Tramadol Hcl
  • Candesartan Cilexetil
  • Acetaminophen And Codeine Phosphate
  • Acetaminophen
and developed a serious reaction and side effect(s): Self-injurious Ideation, Violence-related Symptom, Thinking Abnormal after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Betahistine treatment in female patients, resulting in Self-injurious Ideation side effect.
Betahistine Side Effect Report#8347432-7
Syncope, Vomiting, Loss Of Consciousness, Dizziness
This report suggests a potential Betahistine Syncope side effect(s) that can have serious consequences. A female patient (weight: NA) from United Kingdom was diagnosed with the following symptoms/conditions: NA and used Betahistine (dosage: Prior To 2006) starting
Dec 04, 2009. After starting Betahistine the patient began experiencing various side effects, including: Syncope, Vomiting, Loss Of Consciousness, DizzinessAdditional drugs used concurrently:
  • 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. Although Betahistine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Syncope, may still occur.
Betahistine Side Effect Report#8247377-7
Cerebral Ischaemia
This Cerebral Ischaemia problem was reported by a physician from China. A 81-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: prophylaxis,metastatic renal cell carcinoma,nutritional support. On
Dec 29, 2010 this consumer started treatment with Betahistine Hydrochloride (dosage: 8 Mg, 3x/day). The following drugs were being taken at the same time:
  • Axitinib (3 Mg, 2x/day)
  • Vitamin E (268 Mg, 1x/day)
  • Ascorbic Acid (100 Mg, 1x/day)
  • Vitamin B6 (10 Mg, 1x/day)
When using Betahistine Hydrochloride, the patient experienced the following unwanted symptoms/side effects: Cerebral IschaemiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Cerebral Ischaemia, may become evident only after a product is in use by the general population.
Betahistine Side Effect Report#8244576-5
Blood Bilirubin Increased, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Liver Function Test Abnormal, Renal Impairment
This Blood Bilirubin Increased side effect was reported by a physician from Germany. A female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Betahistine Mesilate (drug dosage: NA), which was initiated on
Dec 18, 2011. Concurrently used drugs:
  • Xarelto
  • Marcumar
  • Micardis
  • Lercanidipine
  • Heparin
.After starting to take Betahistine Mesilate the consumer reported adverse symptoms, such as: Blood Bilirubin Increased, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Liver Function Test Abnormal, Renal ImpairmentThese side effects may potentially be related to Betahistine Mesilate. The patient was hospitalized.
Betahistine Side Effect Report#8193208-3
Malaise, Chest Pain, Dyspepsia, Abdominal Pain Upper, Dizziness, Alopecia, Sleep Disorder, Muscle Spasms, Vision Blurred
This is a report of a 50-year-old female patient (weight: NA) from Netherlands, suffering from the following health symptoms/conditions: NA, who was treated with Betahistine (dosage: NA, start time:
Feb 21, 2011), combined with:
  • Alendronate Sodium (1 Tablet Per Dag)
and developed a serious reaction and side effect(s): Malaise, Chest Pain, Dyspepsia, Abdominal Pain Upper, Dizziness, Alopecia, Sleep Disorder, Muscle Spasms, Vision Blurred after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Betahistine treatment in female patients, resulting in Malaise side effect.
Betahistine Side Effect Report#8156094-3
Dyspnoea, Labyrinthitis, Oedema Peripheral
This report suggests a potential Betahistine (betahistine) (betahistine) Dyspnoea side effect(s) that can have serious consequences. A 51-year-old female patient (weight: NA) from Brazil was diagnosed with the following symptoms/conditions: NA and used Betahistine (betahistine) (betahistine) (dosage: NA) starting
Jan 01, 2011. After starting Betahistine (betahistine) (betahistine) the patient began experiencing various side effects, including: Dyspnoea, Labyrinthitis, Oedema PeripheralAdditional drugs used concurrently:
  • Benicar Hct (20/12.5 Mg (1 In 1 D), Per Oral)
The patient was hospitalized. Although Betahistine (betahistine) (betahistine) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Dyspnoea, may still occur.
Betahistine Side Effect Report#8123557-6
Sinusitis, Feeling Abnormal, Gait Disturbance, Brain Hypoxia, Nervous System Disorder, Cerebrovascular Insufficiency
This Sinusitis problem was reported by a consumer or non-health professional from Brazil. A 46-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: cerebrovascular disorder. On NS this consumer started treatment with Betahistine Dihydrochloride (dosage: 1 Df, Daily). The following drugs were being taken at the same time:
  • Trileptal (300 Mg, Bid)
  • Antidepressants (Unk Ukn, Unk)
  • Hydrochlorothiazide (1 Df, Daily)
  • Enalapril Maleate (1 Df, Daily)
When using Betahistine Dihydrochloride, the patient experienced the following unwanted symptoms/side effects: Sinusitis, Feeling Abnormal, Gait Disturbance, Brain Hypoxia, Nervous System Disorder, Cerebrovascular InsufficiencyAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Sinusitis, may become evident only after a product is in use by the general population.
Betahistine Side Effect Report#8069212-2
Leukoencephalopathy
This Leukoencephalopathy 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 (drug dosage: NA), which was initiated on
Feb 15, 2001. Concurrently used drugs:
  • Methotrexate
  • Acetaminophen
  • Orencia (Last Admin: 15nov11.)
  • Strumazol
.After starting to take Betahistine the consumer reported adverse symptoms, such as: LeukoencephalopathyThese side effects may potentially be related to Betahistine.
Betahistine Side Effect Report#8055094-1
Transitional Cell Carcinoma
This is a report of a female patient (weight: NA) from Belgium, suffering from the following health symptoms/conditions: oesophagitis, who was treated with Betahistine (dosage: NA, start time:
Oct 11, 2011), combined with:
  • Levothyroxine Sodium
  • Michol
  • Pantoprazole
  • Revlimid (20 Milligram)
and developed a serious reaction and side effect(s): Transitional Cell Carcinoma after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Betahistine treatment in female patients, resulting in Transitional Cell Carcinoma side effect.
Betahistine Side Effect Report#8054165-3
Encephalitis, Leukoencephalopathy
This report suggests a potential Betahistine Encephalitis side effect(s) that can have serious consequences. A 77-year-old female patient (weight: NA) from Belgium was diagnosed with the following symptoms/conditions: NA and used Betahistine (dosage: NA) starting
Jan 01, 2000. After starting Betahistine the patient began experiencing various side effects, including: Encephalitis, LeukoencephalopathyAdditional drugs used concurrently:
  • Orencia (Last Admin: 15nov11.)
  • Methotrexate
  • Strumazol
  • Acetaminophen
Although Betahistine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Encephalitis, may still occur.
Betahistine Side Effect Report#8030246-5
Large Intestine Perforation, Hepatic Congestion, Infectious Peritonitis, Platelet Count Increased, Constipation, Pain, Neutrophil Count Increased, Large Intestinal Obstruction
This Large Intestine Perforation problem was reported by a physician from United Kingdom. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Dec 08, 2003 this consumer started treatment with Betahistine (dosage: 1 Ukn, Tid). The following drugs were being taken at the same time:
  • 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)
When using Betahistine, the patient experienced the following unwanted symptoms/side effects: Large Intestine Perforation, Hepatic Congestion, Infectious Peritonitis, Platelet Count Increased, Constipation, Pain, Neutrophil Count Increased, Large Intestinal ObstructionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Large Intestine Perforation, may become evident only after a product is in use by the general population.
Betahistine Side Effect Report#7993585-X
Uveitis
This Uveitis side effect was reported by a physician from Australia. A 77-year-old male patient (weight:NA) experienced the following symptoms/conditions: meniere's disease,hypertension.The patient was prescribed Betahistine Dihydrochloride (drug dosage: 30 Ml, Unk), which was initiated on
Jun 15, 2010. Concurrently used drugs:
  • 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)
.After starting to take Betahistine Dihydrochloride the consumer reported adverse symptoms, such as: UveitisThese side effects may potentially be related to Betahistine Dihydrochloride. The patient was hospitalized.
Betahistine Side Effect Report#7935387-6
Psoriasis
This is a report of a 54-year-old male patient (weight: NA) from France, suffering from the following health symptoms/conditions: NA, who was treated with Betahistine (dosage: NA, start time:
Jan 01, 2009), combined with:
  • Hyzaar
and developed a serious reaction and side effect(s): Psoriasis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Betahistine treatment in male patients, resulting in Psoriasis side effect. The patient was hospitalized.
Betahistine Side Effect Report#7918827-8
Muscular Weakness, Malaise, Headache, Myalgia
This report suggests a potential Betahistine Muscular Weakness side effect(s) that can have serious consequences. A 57-year-old female patient (weight: NA) from United Kingdom was diagnosed with the following symptoms/conditions: NA and used Betahistine (dosage: Unk) starting
Oct 14, 2011. After starting Betahistine the patient began experiencing various side effects, including: Muscular Weakness, Malaise, Headache, MyalgiaAdditional drugs used concurrently:
  • Sodium Docusate (Unk)
  • Prochlorperazine (Unk)
  • Acetaminophen (Unk)
  • Prednisolone (20 Mg, Unk)
  • Albuterol Sulfate Autohaler (Unk)
  • Warfarin Sodium (Unk)
  • Fluticasone Propionate/salmeterol (Unk)
  • Senna (Unk)
The patient was hospitalized. Although Betahistine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Muscular Weakness, may still occur.
Betahistine Side Effect Report#7699871-5
Liver Function Test Abnormal, Cholestasis, Myositis
This 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 (dosage: NA). The following drugs were being taken at the same time:
  • Nitroglycerin
  • Felodipine
  • Doxycycline
  • Doxycycline
  • Bumetanide
  • Clopidogrel
  • Fluoxetine
  • Isosorbide Mononitrate
When using Betahistine, the patient experienced the following unwanted symptoms/side effects: Liver Function Test Abnormal, Cholestasis, MyositisThe 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 Liver Function Test Abnormal, may become evident only after a product is in use by the general population.
Betahistine Side Effect Report#7655465-9
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 (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Previscan
  • Alendronic Acid
  • Nicardipine Hcl
  • Diacerein
  • Amiodarone Hcl
  • Forlax
  • Stresam
  • Indapamide
.After starting to take Betahistine Dihydrochloride the consumer reported adverse symptoms, such as: Decreased Appetite, Balance Disorder, Movement Disorder, Fall, Hyponatraemia, Hypokalaemia, AstheniaThese side effects may potentially be related to Betahistine Dihydrochloride. The patient was hospitalized.
Betahistine Side Effect Report#7650752-2
Anaemia Megaloblastic, Vitamin B12 Deficiency
This is a report of a 85-year-old female patient (weight: NA) from Portugal, suffering from the following health 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): Anaemia Megaloblastic, Vitamin B12 Deficiency 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.
Betahistine Side Effect Report#7639843-X
Myositis, Liver Function Test Abnormal, Cholestasis
This report suggests a potential Betahistine Myositis 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. After starting Betahistine the patient began experiencing various side effects, including: Myositis, Liver Function Test Abnormal, CholestasisAdditional 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.
Betahistine Side Effect Report#7620885-5
Cholestasis, Myositis, Blood Creatine Phosphokinase Increased, Liver Function Test Abnormal
This Cholestasis 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 using Betahistine Hydrochloride, the patient experienced the following unwanted symptoms/side effects: Cholestasis, Myositis, Blood Creatine Phosphokinase Increased, Liver Function Test AbnormalThe 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.
Betahistine Side Effect Report#7503325-6
Brain Herniation
This Brain Herniation side effect was reported by a physician from Germany. A male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Betahistine (drug dosage: NA), which was initiated on
Aug 08, 2005. Concurrently used drugs:
  • Omeprazole
  • Amlodipine
  • Tasigna (400 Mg, Bid)
  • Prednisone
  • Enalapril Maleate
  • Hydrochlorothiazde Tab
  • Magnesium
.After starting to take Betahistine the consumer reported adverse symptoms, such as: Brain HerniationThese side effects may potentially be related to Betahistine. The patient was hospitalized.
Betahistine Side Effect Report#7497761-4
Stomatitis
This is a report of a 67-year-old female patient (weight: NA) from Germany, suffering from the following health symptoms/conditions: hypertension,osteoporosis,rheumatoid arthritis, who was treated with Betahistine (dosage: 24 Mg, Unk, start time:
Jan 01, 2009), combined with:
  • 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)
and developed a serious reaction and side effect(s): Stomatitis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Betahistine treatment in female patients, resulting in Stomatitis side effect.


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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.

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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:

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  • 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.

    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.

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    More About Betahistine

    Side Effects reported to FDA: 29

    Betahistine safety alerts: No

    Reported deaths: 2

    Reported hospitalizations: 10

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