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Alfarol Side Effects

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Common Alfarol Side Effects


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

Loss Of Consciousness (5)
Liver Disorder (3)
Rash (3)
Deep Vein Thrombosis (3)
Blood Potassium Decreased (2)
Altered State Of Consciousness (2)
Blood Sodium Increased (2)
Dermatitis (2)
Disseminated Intravascular Coagulation (2)
Hepatitis (2)
Cerebral Haemorrhage (2)
Cardiac Failure (2)
Road Traffic Accident (2)
Pleurisy (2)
Platelet Count Decreased (2)
Pneumonia Pneumococcal (2)
Renal Impairment (2)
Skin Ulcer (2)
Retinal Haemorrhage (2)
Hypocalcaemia (2)

➢ 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.

Alfarol Side Effects Reported to FDA



Alfarol Side Effect Report#8443188-8
Rash
This is a report of a 68-year-old male patient (weight: NA) from Japan, suffering from the following health symptoms/conditions: NA, who was treated with Alfarol (dosage: NA, start time:
Apr 18, 2012), combined with:
  • Nateglinide
  • Rebetol
  • Peginterferon Alfa-2b
  • Locholest
  • Telavic (telaprevir)
and developed a serious reaction and side effect(s): Rash after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Alfarol treatment in male patients, resulting in Rash side effect.
Alfarol Side Effect Report#8406261-6
Liver Disorder, Haemosiderosis, Hepatitis, Fatigue, Periportal Oedema
This report suggests a potential Alfarol Liver Disorder side effect(s) that can have serious consequences. A female patient (weight: NA) from Japan was diagnosed with the following symptoms/conditions: NA and used Alfarol (dosage: 0.5 Ug, Unk) starting
Feb 13, 2009. After starting Alfarol the patient began experiencing various side effects, including: Liver Disorder, Haemosiderosis, Hepatitis, Fatigue, Periportal OedemaAdditional drugs used concurrently:
  • Exjade (1000 Mg, Daily)
  • Fosamax (5 Mg, Unk)
  • Pravastatin Sodium (10 Mg, Unk)
  • Exjade (1000 Mg, Daily)
  • Calblock (16 Mg, Unk)
  • Glakay (45 Mg, Unk)
  • Exjade (500 Mg, Daily)
Although Alfarol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Liver Disorder, may still occur.
Alfarol Side Effect Report#8402153-7
Myocardial Ischaemia
This Myocardial Ischaemia problem was reported by a physician from Japan. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: osteoporosis,peripheral circulatory failure. On
Jul 07, 2009 this consumer started treatment with Alfarol (dosage: 1 Df, Daily). The following drugs were being taken at the same time:
  • Tocopherol /00110502/ (600 Mg, Daily)
  • Buprenorphine
  • Olmesartan Medoxomil (1 Df, Daily)
  • Buprenorphine (5 Mcg, Q1h)
  • Mobic (1 Df, Daily)
  • Lansoprazole (1 Df, Daily)
  • Alendronate Sodium (1 Df, Daily)
  • Buprenorphine
When using Alfarol, the patient experienced the following unwanted symptoms/side effects: Myocardial IschaemiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Myocardial Ischaemia, may become evident only after a product is in use by the general population.
Alfarol Side Effect Report#8347374-7
Loss Of Consciousness, Road Traffic Accident, Dermatitis
This Loss Of Consciousness side effect was reported by a pharmacist from Japan. A male patient (weight:NA) experienced the following symptoms/conditions: renal failure chronic.The patient was prescribed Alfarol (drug dosage: NA), which was initiated on
Mar 09, 2012. Concurrently used drugs:
  • Argamate
  • Mircera
.After starting to take Alfarol the consumer reported adverse symptoms, such as: Loss Of Consciousness, Road Traffic Accident, DermatitisThese side effects may potentially be related to Alfarol. The patient was hospitalized.
Alfarol Side Effect Report#8338403-5
Haemoglobin Decreased, Gastrointestinal Erosion
This is a report of a male patient (weight: NA) from Japan, suffering from the following health symptoms/conditions: NA, who was treated with Alfarol (dosage: NA, start time:
Mar 19, 2012), combined with:
  • Tenormin
  • Omeprazole
  • Epogin S
  • Plavix
  • Atelec
  • Mircera
  • Epogin S
  • Besacolin
and developed a serious reaction and side effect(s): Haemoglobin Decreased, Gastrointestinal Erosion after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Alfarol treatment in male patients, resulting in Haemoglobin Decreased side effect. The patient was hospitalized.
Alfarol Side Effect Report#8295906-X
Macular Oedema
This report suggests a potential Alfarol Macular Oedema side effect(s) that can have serious consequences. A female patient (weight: NA) from Japan was diagnosed with the following symptoms/conditions: osteoporosis,hypercholesterolaemia,constipation prophylaxis,peripheral sensory neuropathy and used Alfarol (dosage: NA) starting
Oct 14, 2011. After starting Alfarol the patient began experiencing various side effects, including: Macular OedemaAdditional drugs used concurrently:
  • Lipitor
  • Milmag
  • Lyrica
  • Milmag
  • Abraxane
  • Actonel
  • Zometa
  • Abraxane (132 Milligram)
Although Alfarol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Macular Oedema, may still occur.
Alfarol Side Effect Report#8282933-1
Loss Of Consciousness, Road Traffic Accident, Dermatitis
This Loss Of Consciousness problem was reported by a physician from Japan. A male patient (weight: NA) was diagnosed with the following symptoms/conditions: renal failure chronic. On
Mar 09, 2012 this consumer started treatment with Alfarol (dosage: NA). The following drugs were being taken at the same time:
  • Argamate
  • Mircera
When using Alfarol, the patient experienced the following unwanted symptoms/side effects: Loss Of Consciousness, Road Traffic Accident, DermatitisThe 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 Loss Of Consciousness, may become evident only after a product is in use by the general population.
Alfarol Side Effect Report#8216573-7
Blood Parathyroid Hormone Increased, Hypocalcaemia, Hyperphosphataemia
This Blood Parathyroid Hormone Increased side effect was reported by a health professional from Japan. A 2-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Alfarol (drug dosage: 0.5 Mug, Qd), which was initiated on
Sep 08, 2011. Concurrently used drugs:
  • Oxarol (2.5 Mug, 3 Times/wk -15 Time Execution)
  • Renagel (250 Mg, Qd)
  • Renagel (250 Mg, Tid)
  • Calcium Carbonate (1 G, Tid)
  • Cinacalcet Hydrochloride
  • Cinacalcet Hydrochloride
  • Ferrous Citrate
.After starting to take Alfarol the consumer reported adverse symptoms, such as: Blood Parathyroid Hormone Increased, Hypocalcaemia, HyperphosphataemiaThese side effects may potentially be related to Alfarol. The patient was hospitalized.
Alfarol Side Effect Report#8209552-7
Retinal Haemorrhage
This is a report of a 60-year-old female patient (weight: NA) from Japan, suffering from the following health symptoms/conditions: NA, who was treated with Alfarol (dosage: NA, start time:
Feb 13, 2012), combined with:
  • Folic Acid
  • Loxonin
  • Prednisolone
  • Simponi
  • Famotidine
  • Rheumatrex
and developed a serious reaction and side effect(s): Retinal Haemorrhage after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Alfarol treatment in female patients, resulting in Retinal Haemorrhage side effect.
Alfarol Side Effect Report#8201533-2
Blood Sodium Increased, Blood Potassium Increased, Blood Creatinine Increased, Blood Urea Increased, Altered State Of Consciousness, Renal Impairment, Urine Output Decreased, Renal Failure Acute, Muscular Weakness
This report suggests a potential Alfarol Blood Sodium Increased side effect(s) that can have serious consequences. A female patient (weight: NA) from Japan was diagnosed with the following symptoms/conditions: osteoporosis,hypertension,diabetes mellitus,constipation and used Alfarol (dosage: 1mcg Per Day) starting
Jan 17, 2012. After starting Alfarol the patient began experiencing various side effects, including: Blood Sodium Increased, Blood Potassium Increased, Blood Creatinine Increased, Blood Urea Increased, Altered State Of Consciousness, Renal Impairment, Urine Output Decreased, Renal Failure Acute, Muscular WeaknessAdditional drugs used concurrently:
  • Micardis (40mg Per Day)
  • Metformin Hcl
  • Alosenn (1g Per Day)
  • Adona (ac-17) (90mg Per Day)
  • Gabapentin (400mg Per Day)
  • Circuletin (75mg Per Day)
  • Livalo (2mg Per Day)
  • Valtrex (3000mg Per Day)
Although Alfarol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Blood Sodium Increased, may still occur.
Alfarol Side Effect Report#8199440-7
Feeling Abnormal, Feeling Hot, Flushing, Terminal Dribbling, Pain, Hepatitis, Rash, Dizziness, Insomnia
This Feeling Abnormal problem was reported by a consumer or non-health professional from Japan. A 78-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Dec 23, 2011 this consumer started treatment with Alfarol (dosage: Unk). The following drugs were being taken at the same time:
  • Hydrochlorothiazide (Unk)
  • Forteo (Unk)
  • Prednisolone (Unk)
  • Depas (Unk)
  • Olmesartan Medoxomil (Unk)
  • Clinoril
  • Rabeprazole Sodium (Unk)
  • Lyrica (Unk)
When using Alfarol, the patient experienced the following unwanted symptoms/side effects: Feeling Abnormal, Feeling Hot, Flushing, Terminal Dribbling, Pain, Hepatitis, Rash, Dizziness, InsomniaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Feeling Abnormal, may become evident only after a product is in use by the general population.
Alfarol Side Effect Report#8175230-6
Hypoaesthesia, Hypocalcaemia, Blood Calcium Decreased, Tetany
This Hypoaesthesia side effect was reported by a health professional from Japan. A 38-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Alfarol (alfacalcidol) (drug dosage: NA), which was initiated on
Apr 06, 2009. Concurrently used drugs:
  • Calciuim (calcium)
  • Actonel (17.5 Mg Once Daily, Oral)
  • Actonel (17.5 Mg Once Daily, Oral)
.After starting to take Alfarol (alfacalcidol) the consumer reported adverse symptoms, such as: Hypoaesthesia, Hypocalcaemia, Blood Calcium Decreased, TetanyThese side effects may potentially be related to Alfarol (alfacalcidol).
Alfarol Side Effect Report#8118759-9
Purulent Discharge, Paralysis, Blood Albumin Decreased, No Therapeutic Response, Osteomyelitis, Facial Pain, Inflammation, Exposed Bone In Jaw, Swelling Face
This is a report of a 84-year-old female patient (weight: NA) from Japan, suffering from the following health symptoms/conditions: NA, who was treated with Alfarol (alfacalcidol) (dosage: NA, start time:
Apr 01, 2010), combined with:
  • Risedronate Sodium (Oral)
  • Ferromia (ferrous Sodiulm Citrate)
  • Etodolac
  • Bufferin
  • Tizanin (tizanidine Hydrochloride)
  • Blopress (candesartan Cilexetil)
  • Diart (azosemide)
  • Tenormin
and developed a serious reaction and side effect(s): Purulent Discharge, Paralysis, Blood Albumin Decreased, No Therapeutic Response, Osteomyelitis, Facial Pain, Inflammation, Exposed Bone In Jaw, Swelling Face after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Alfarol (alfacalcidol) treatment in female patients, resulting in Purulent Discharge side effect. The patient was hospitalized.
Alfarol Side Effect Report#7936706-7
Liver Disorder
This report suggests a potential Alfarol Liver Disorder side effect(s) that can have serious consequences. A female patient (weight: NA) from Japan was diagnosed with the following symptoms/conditions: NA and used Alfarol (dosage: 0.5 Mcg, Qd) starting
Sep 14, 2011. After starting Alfarol the patient began experiencing various side effects, including: Liver DisorderAdditional drugs used concurrently:
  • Cinacalcet Hydrochloride (25 Mg, Qd)
  • Renagel (0.5 G, Tid)
The patient was hospitalized. Although Alfarol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Liver Disorder, may still occur.
Alfarol Side Effect Report#7921348-X
Nephrolithiasis, Hydronephrosis
This Nephrolithiasis problem was reported by a physician from Japan. A male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Sep 04, 2008 this consumer started treatment with Alfarol (dosage: From:peroral Agent, Dosage Is Uncertain). The following drugs were being taken at the same time:
  • Actemra
  • Actemra
  • Adrenal Hormone Preparation (unk Ingredients) (Form: Peroral Agent)
  • Actemra
When using Alfarol, the patient experienced the following unwanted symptoms/side effects: Nephrolithiasis, HydronephrosisThe 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 Nephrolithiasis, may become evident only after a product is in use by the general population.
Alfarol Side Effect Report#7919150-8
Post Procedural Infection, Cholelithiasis
This Post Procedural Infection side effect was reported by a physician from Japan. A female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Alfarol (drug dosage: NA), which was initiated on
Dec 19, 2008. Concurrently used drugs:
  • Amlodipine
  • Rhythmy (Single Use)
  • Diazepam (Single Use)
  • Actemra
  • Zantac
  • Morphine Hcl Elixir
  • Motilium
  • Ketoprofen
.After starting to take Alfarol the consumer reported adverse symptoms, such as: Post Procedural Infection, CholelithiasisThese side effects may potentially be related to Alfarol. The patient was hospitalized.
Alfarol Side Effect Report#7913328-5
Liver Disorder
This is a report of a 59-year-old female patient (weight: NA) from Japan, suffering from the following health symptoms/conditions: NA, who was treated with Alfarol (dosage: Uncertainty, start time:
Aug 01, 2011), combined with:
  • Cinacalcet Hydrochloride (Unk)
  • Renagel (Uncertainty)
and developed a serious reaction and side effect(s): Liver Disorder after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Alfarol treatment in female patients, resulting in Liver Disorder side effect. The patient was hospitalized.
Alfarol Side Effect Report#7789564-8
Lymph Node Tuberculosis
This report suggests a potential Alfarol Lymph Node Tuberculosis side effect(s) that can have serious consequences. A 31-year-old male patient (weight: NA) from Japan was diagnosed with the following symptoms/conditions: prophylaxis,ankylosing spondylitis and used Alfarol (dosage: 0.25 Rg Daily) starting
Feb 03, 2011. After starting Alfarol the patient began experiencing various side effects, including: Lymph Node TuberculosisAdditional drugs used concurrently:
  • Remicade
  • Isoniazid (100df)
  • Isoniazid (200df)
  • Calcium Carbonate
  • Isoniazid (50df)
  • Tamiflu
  • Isoniazid (300df)
  • Pydoxal
The patient was hospitalized. Although Alfarol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Lymph Node Tuberculosis, may still occur.
Alfarol Side Effect Report#7759789-6
Arrhythmia
This Arrhythmia problem was reported by a health professional from Japan. A 40-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: osteoporosis,gastritis,iron deficiency anaemia,cardiac failure,idiopathic thrombocytopenic purpura,thrombocytopenia. On
Dec 03, 2010 this consumer started treatment with Alfarol (dosage: 0.25 Mug, Qd). The following drugs were being taken at the same time:
  • Lansoprazole (30 Mg, Prn)
  • Ferrous Citrate (50 Mg, Qd)
  • Carvedilol (2.5 Mg, Bid)
  • Romiplostim (8 Mug/kg, Qwk)
  • Prednisolone (5 Mg, Qd)
  • Tambocor (50 Mg, Bid)
  • Pimenol (50 Mg, Bid)
When using Alfarol, the patient experienced the following unwanted symptoms/side effects: ArrhythmiaThe 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 Arrhythmia, may become evident only after a product is in use by the general population.
Alfarol Side Effect Report#7743002-X
Skin Ulcer, Pneumonia Pneumococcal, Pleurisy, Loss Of Consciousness
This Skin Ulcer side effect was reported by a health professional from Japan. A female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Alfarol (drug dosage: NA), which was initiated on
Dec 22, 2010. Concurrently used drugs:
  • Loxonin
  • Risedronate Sodium
  • Azulfidine
  • Prednisolone
  • Solu-medrol (Start Date And End Date: 29 March 2011)
  • Solu-medrol (Start Date And End Date: 31 March 2011)
  • Juvela (Form: Peroral Agent)
  • Solu-medrol (Start Date And End Date: 30 March 2011)
.After starting to take Alfarol the consumer reported adverse symptoms, such as: Skin Ulcer, Pneumonia Pneumococcal, Pleurisy, Loss Of ConsciousnessThese side effects may potentially be related to Alfarol. The patient was hospitalized.
Alfarol Side Effect Report#7737294-0
Altered State Of Consciousness, Hyponatraemia, Vomiting, Dyskinesia, Headache
This is a report of a 68-year-old female patient (weight: NA) from Japan, suffering from the following health symptoms/conditions: osteoporosis, who was treated with Alfarol (dosage: NA, start time:
Aug 05, 2011), combined with:
  • Succinylcholine Chloride Inj
  • Atarax
  • Evista
  • Tsumura Daikentyuto
  • Diprivan
  • Potassium Chloride
  • Pantosin
  • Soft Santear
and developed a serious reaction and side effect(s): Altered State Of Consciousness, Hyponatraemia, Vomiting, Dyskinesia, Headache after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Alfarol treatment in female patients, resulting in Altered State Of Consciousness side effect. The patient was hospitalized.
Alfarol Side Effect Report#7734649-5
Femur Fracture
This report suggests a potential Alfarol Femur Fracture side effect(s) that can have serious consequences. A 76-year-old female patient (weight: NA) from Japan was diagnosed with the following symptoms/conditions: osteoporosis and used Alfarol (dosage: NA) starting
Jan 01, 2006. After starting Alfarol the patient began experiencing various side effects, including: Femur FractureAdditional drugs used concurrently:
  • Pyridoxal Phosphate
  • Kenton (vitamin E Nicotinate)
  • Prednisolone
  • Mecobalamin
  • Fosamax
  • Metalcaptase
  • Dorner
  • Lipitor
The patient was hospitalized. Although Alfarol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Femur Fracture, may still occur.
Alfarol Side Effect Report#7693886-9
Cerebral Haemorrhage
This Cerebral Haemorrhage problem was reported by a physician from Japan. A 61-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jul 22, 2011 this consumer started treatment with Alfarol (dosage: 0.25 Mg). The following drugs were being taken at the same time:
  • Rabeprazole Sodium (10 Mg)
  • Exforge
  • Lasix (40 Mg)
  • Fosrenol (1500 Mg)
  • Calcium Compounds And Preparations (2000 Mg)
  • Tranexamic Acid (2250 Mg)
  • Pradaxa (220 Mg)
  • Doxazosin Mesylate (2 Mg)
When using Alfarol, the patient experienced the following unwanted symptoms/side effects: Cerebral HaemorrhageAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Cerebral Haemorrhage, may become evident only after a product is in use by the general population.
Alfarol Side Effect Report#7690306-5
Aspartate Aminotransferase Increased, Blood Potassium Decreased, Condition Aggravated, Cardiac Failure, Blood Bilirubin Increased, Hepatic Function Abnormal, Blood Sodium Increased, Alanine Aminotransferase Increased
This Aspartate Aminotransferase Increased side effect was reported by a physician from Japan. A 73-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Alfarol (alfacalcidol) (drug dosage: NA), which was initiated on
Apr 28, 2011. Concurrently used drugs:
  • Cetapril (alacepril)
  • Allopurinol
  • Acardi (pimobendan)
  • Mexitil
  • Aldactone
  • Amaryl
  • Zantac
  • Prednisolone (prednisolone Sodium Phosphate)
.After starting to take Alfarol (alfacalcidol) the consumer reported adverse symptoms, such as: Aspartate Aminotransferase Increased, Blood Potassium Decreased, Condition Aggravated, Cardiac Failure, Blood Bilirubin Increased, Hepatic Function Abnormal, Blood Sodium Increased, Alanine Aminotransferase IncreasedThese side effects may potentially be related to Alfarol (alfacalcidol).
Alfarol Side Effect Report#7679827-9
Acute Disseminated Encephalomyelitis, Urinary Tract Infection, Lumbar Spinal Stenosis, Disseminated Intravascular Coagulation, Blood Phosphorus Decreased, Platelet Count Decreased, Temperature Intolerance, Blood Potassium Decreased, Tinnitus
This is a report of a 70-year-old female patient (weight: NA) from Japan, suffering from the following health symptoms/conditions: NA, who was treated with Alfarol (dosage: Unk, start time:
Dec 20, 2006), combined with:
  • Fosamax (Unk)
  • Aspara-ca (Unk)
  • Prelone (Unk)
  • Prograf (Unk)
  • Prograf (Unk)
  • Enbrel (50 Mg, Qwk)
  • Rheumatrex (Unk)
  • Loxonin (Unk)
and developed a serious reaction and side effect(s): Acute Disseminated Encephalomyelitis, Urinary Tract Infection, Lumbar Spinal Stenosis, Disseminated Intravascular Coagulation, Blood Phosphorus Decreased, Platelet Count Decreased, Temperature Intolerance, Blood Potassium Decreased, Tinnitus after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Alfarol treatment in female patients, resulting in Acute Disseminated Encephalomyelitis side effect. The patient was hospitalized.

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The appearance of Alfarol 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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  • 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.

    Alfarol 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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    Side Effects reported to FDA: 44

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    Reported deaths: 6

    Reported hospitalizations: 26

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