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Aprovel Side Effects

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Common Aprovel Side Effects


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

Renal Failure Acute (48)
Hyponatraemia (40)
Fall (31)
Hyperkalaemia (27)
Diarrhoea (23)
Renal Failure (22)
Confusional State (21)
Anaemia (18)
Hypotension (17)
Blood Creatine Phosphokinase Increased (17)
Asthenia (16)
Dehydration (16)
Nausea (16)
Vomiting (14)
Hypertension (12)
Dizziness (11)
Orthostatic Hypotension (11)
Dyspnoea (11)
Myalgia (11)
Thrombocytopenia (10)

➢ 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.

Aprovel Side Effects Reported to FDA



Aprovel Side Effect Report#9989316
Heart Disease Congenital, Maternal Exposure During Pregnancy, Pulmonary Artery Atresia
This is a report of a female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Aprovel (dosage: NA, start time:
Dec 19, 2009), combined with:
  • Sirolimus
  • Cellcept
  • Prograf
  • Imurel
  • Sectral
  • Omeprazole
  • Cortancyl
  • Aspegic
and developed a serious reaction and side effect(s): Heart Disease Congenital, Maternal Exposure During Pregnancy, Pulmonary Artery Atresia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Aprovel treatment in female patients, resulting in Heart Disease Congenital side effect. The patient was hospitalized.
Aprovel Side Effect Report#9961394
Somnolence, Confusional State, Dysarthria
This report suggests a potential Aprovel Somnolence side effect(s) that can have serious consequences. A 71-year-old male patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: NA and used Aprovel (dosage: Strength: 150mg) starting NS. After starting Aprovel the patient began experiencing various side effects, including: Somnolence, Confusional State, DysarthriaAdditional drugs used concurrently:
  • Zebinix
  • Previscan
  • Allopurinol
  • Kardegic
  • Colchimax
  • Lasilix
  • Tahor
The patient was hospitalized. Although Aprovel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Somnolence, may still occur.
Aprovel Side Effect Report#9867333
Pancytopenia, Haemoglobin Decreased, Platelet Count Decreased
This Pancytopenia problem was reported by a health professional from FR. A 64-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Aprovel (dosage: NA). The following drugs were being taken at the same time:
  • Gliclazide
  • Tahor
  • Janumet
  • Pariet
When using Aprovel, the patient experienced the following unwanted symptoms/side effects: Pancytopenia, Haemoglobin Decreased, Platelet Count DecreasedThe 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 Pancytopenia, may become evident only after a product is in use by the general population.
Aprovel Side Effect Report#9838128
Thrombotic Stroke, Acute Myocardial Infarction, Hypokalaemia, Hyponatraemia
This Thrombotic Stroke side effect was reported by a consumer or non-health professional from CO. A 88-year-old female patient (weight:NA) experienced the following symptoms/conditions: hypertension.The patient was prescribed Aprovel (drug dosage: NA), which was initiated on 2010. Concurrently used drugs: NA..After starting to take Aprovel the consumer reported adverse symptoms, such as: Thrombotic Stroke, Acute Myocardial Infarction, Hypokalaemia, HyponatraemiaThese side effects may potentially be related to Aprovel. The patient was hospitalized.
Aprovel Side Effect Report#9822047
Infarction
This is a report of a 77-year-old female patient (weight: NA) from MX, suffering from the following health symptoms/conditions: hypertension, who was treated with Aprovel (dosage: Strength: 150 Mg, start time: 2005), combined with: NA. and developed a serious reaction and side effect(s): Infarction after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Aprovel treatment in female patients, resulting in Infarction side effect.
Aprovel Side Effect Report#9752517
Dermatitis Bullous, Tremor, Pyrexia, Blister, Cough, Face Oedema
This report suggests a potential Aprovel Dermatitis Bullous side effect(s) that can have serious consequences. A 53-year-old patient (weight: NA) from MY was diagnosed with the following symptoms/conditions: hypertension and used Aprovel (dosage: NA) starting NS. After starting Aprovel the patient began experiencing various side effects, including: Dermatitis Bullous, Tremor, Pyrexia, Blister, Cough, Face OedemaAdditional drugs used concurrently:
  • Aspirin
  • Hydrochlorothiazide
  • Simvastatin
  • Bisoprolol
  • Isosorbide Mononitrate
  • Amlodipine
Although Aprovel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Dermatitis Bullous, may still occur.
Aprovel Side Effect Report#9723596
Weight Decreased, Type 1 Diabetes Mellitus, Hypercholesterolaemia, Autoimmune Hepatitis, Hepatitis Cholestatic, Sinus Tachycardia, Orthostatic Hypotension
This Weight Decreased problem was reported by a physician from FR. A 71-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: hypertension,atrial fibrillation. On 200802 this consumer started treatment with Aprovel (dosage: NA). The following drugs were being taken at the same time:
  • Flecaine
When using Aprovel, the patient experienced the following unwanted symptoms/side effects: Weight Decreased, Type 1 Diabetes Mellitus, Hypercholesterolaemia, Autoimmune Hepatitis, Hepatitis Cholestatic, Sinus Tachycardia, Orthostatic HypotensionThe 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 Weight Decreased, may become evident only after a product is in use by the general population.
Aprovel Side Effect Report#9716747
Hyponatraemia
This Hyponatraemia side effect was reported by a physician from ES. A 86-year-old female patient (weight:NA) experienced the following symptoms/conditions: hypertension.The patient was prescribed Aprovel (drug dosage: NA), which was initiated on 201211. Concurrently used drugs:
  • Mirtazapine
.After starting to take Aprovel the consumer reported adverse symptoms, such as: HyponatraemiaThese side effects may potentially be related to Aprovel. The patient was hospitalized.
Aprovel Side Effect Report#9701655
Macular Oedema, Cataract
This is a report of a 54-year-old male patient (weight: NA) from TN, suffering from the following health symptoms/conditions: NA, who was treated with Aprovel (dosage: NA, start time: NS), combined with:
  • Amarel
  • Glucophage
  • Vildagliptin
and developed a serious reaction and side effect(s): Macular Oedema, Cataract after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Aprovel treatment in male patients, resulting in Macular Oedema side effect.
Aprovel Side Effect Report#9693156
Vasculitis
This report suggests a potential Aprovel Vasculitis side effect(s) that can have serious consequences. A 82-year-old female patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: NA and used Aprovel (dosage: Strength: 150 Mg) starting NS. After starting Aprovel the patient began experiencing various side effects, including: VasculitisAdditional drugs used concurrently: NA. Although Aprovel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Vasculitis, may still occur.
Aprovel Side Effect Report#9688370
Tendonitis
This Tendonitis problem was reported by a health professional from FR. A 62-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: hypertension. On 201304 this consumer started treatment with Aprovel (dosage: NA). The following drugs were being taken at the same time: NA. When using Aprovel, the patient experienced the following unwanted symptoms/side effects: TendonitisAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Tendonitis, may become evident only after a product is in use by the general population.
Aprovel Side Effect Report#9664122
Hypertension, Type 2 Diabetes Mellitus
This Hypertension side effect was reported by a consumer or non-health professional from MX. A 64-year-old female patient (weight:NA) experienced the following symptoms/conditions: hypertension,osteoarthritis.The patient was prescribed Aprovel (drug dosage: NA), which was initiated on 2007. Concurrently used drugs:
  • Arcoxia (Strength: 90 Mg)
.After starting to take Aprovel the consumer reported adverse symptoms, such as: Hypertension, Type 2 Diabetes MellitusThese side effects may potentially be related to Aprovel.
Aprovel Side Effect Report#9660179
Acidosis Hyperchloraemic, Hyperkalaemia
This is a report of a 66-year-old female patient (weight: NA) from IT, suffering from the following health symptoms/conditions: hypertension, who was treated with Aprovel (dosage: NA, start time:
Sep 03, 2013), combined with:
  • Kanrenol
  • Asa
  • Metformin Hydrochloride
  • Solosa
  • Competact (2 Posological Unit)
  • Totalip
  • Lyrica
and developed a serious reaction and side effect(s): Acidosis Hyperchloraemic, Hyperkalaemia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Aprovel treatment in female patients, resulting in Acidosis Hyperchloraemic side effect. The patient was hospitalized.
Aprovel Side Effect Report#9607931
Pancreatitis Acute, Abdominal Pain, Diarrhoea
This report suggests a potential Aprovel Pancreatitis Acute side effect(s) that can have serious consequences. A 73-year-old male patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: hypertension,type 2 diabetes mellitus and used Aprovel (dosage: NA) starting 2004. After starting Aprovel the patient began experiencing various side effects, including: Pancreatitis Acute, Abdominal Pain, DiarrhoeaAdditional drugs used concurrently:
  • Velmetia
  • Fludex
  • Detensiel
  • Previscan
  • Crestor
  • Amarel
The patient was hospitalized. Although Aprovel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pancreatitis Acute, may still occur.
Aprovel Side Effect Report#9514176
Hypertension
This Hypertension problem was reported by a consumer or non-health professional from US. A 73-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: hypertension. On NS this consumer started treatment with Aprovel (dosage: Aprovel 150mg). The following drugs were being taken at the same time: NA. When using Aprovel, the patient experienced the following unwanted symptoms/side effects: HypertensionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hypertension, may become evident only after a product is in use by the general population.
Aprovel Side Effect Report#9472898
Hyponatraemia, Hepatitis, Renal Failure Acute
This Hyponatraemia side effect was reported by a consumer or non-health professional from FR. A 48-year-old male patient (weight:NA) experienced the following symptoms/conditions: hypertension.The patient was prescribed Aprovel (drug dosage: NA), which was initiated on
Jun 27, 2013. Concurrently used drugs:
  • Lasilix
  • Zyloric
  • Ketum
  • Cordarone
  • Cardensiel
  • Previscan
  • Vitamin K
.After starting to take Aprovel the consumer reported adverse symptoms, such as: Hyponatraemia, Hepatitis, Renal Failure AcuteThese side effects may potentially be related to Aprovel. The patient was hospitalized.
Aprovel Side Effect Report#9458194
Depression, Hyponatraemia, Blood Osmolarity Decreased, Malaise
This is a report of a 79-year-old male patient (weight: NA) from FR, suffering from the following health symptoms/conditions: hypertension, who was treated with Aprovel (dosage: In Morning, start time:
Jul 18, 2013), combined with:
  • Coaprovel
  • Haldol (Strength: 2mg/ml?dose:4-10 Drops In Evening)
  • Haldol (Strength: 2mg/ml?dose:4-10 Drops In Evening)
  • Laroxyl
  • Forlax
  • Xanax
  • Paracetamol
  • Imovane
and developed a serious reaction and side effect(s): Depression, Hyponatraemia, Blood Osmolarity Decreased, Malaise after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Aprovel treatment in male patients, resulting in Depression side effect. The patient was hospitalized.
Aprovel Side Effect Report#9425171
Dizziness, Nausea
This report suggests a potential Aprovel Dizziness side effect(s) that can have serious consequences. A 68-year-old male patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: hypertension,cerebrovascular accident and used Aprovel (dosage: NA) starting
Jun 10, 2013. After starting Aprovel the patient began experiencing various side effects, including: Dizziness, NauseaAdditional drugs used concurrently: NA. Although Aprovel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Dizziness, may still occur.
Aprovel Side Effect Report#9410593
Fall
This Fall problem was reported by a consumer or non-health professional from FR. A 94-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Mar 28, 2013 this consumer started treatment with Aprovel Film-coated Tabs 150 Mg (dosage: NA). The following drugs were being taken at the same time:
  • Alprazolam (Scored Tablet)
  • Doliprane (500 Mg Tabs)
  • Imovane (Film-coated Scored Tablet)
  • Mianserin (Film-coated Scored Tablet)
  • Lasilix Faible
  • Gelox
  • Lansoyl
  • Transipeg
When using Aprovel Film-coated Tabs 150 Mg, the patient experienced the following unwanted symptoms/side effects: FallAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Fall, may become evident only after a product is in use by the general population.
Aprovel Side Effect Report#9408053
Umbilical Hernia
This Umbilical Hernia side effect was reported by a consumer or non-health professional from CH. A female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Aprovel (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Aprovel the consumer reported adverse symptoms, such as: Umbilical HerniaThese side effects may potentially be related to Aprovel.
Aprovel Side Effect Report#9403701
Carotid Artery Stenosis, Cerebrovascular Accident, Dizziness
This is a report of a 68-year-old male patient (weight: NA) from FR, suffering from the following health symptoms/conditions: hypertension, who was treated with Aprovel Film-coated Tabs (dosage: Aprovel 150mg And Aprovel 300 Mg., start time: NS), combined with:
  • Tahor
  • Inexium
  • Stagid
and developed a serious reaction and side effect(s): Carotid Artery Stenosis, Cerebrovascular Accident, Dizziness after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Aprovel Film-coated Tabs treatment in male patients, resulting in Carotid Artery Stenosis side effect. The patient was hospitalized.
Aprovel Side Effect Report#9386484
Hyperkalaemia, Renal Failure Acute, Dehydration, Anaemia, Femur Fracture
This report suggests a potential Aprovel Tabs 150 Mg Hyperkalaemia side effect(s) that can have serious consequences. A 79-year-old female patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: hypertension and used Aprovel Tabs 150 Mg (dosage: NA) starting
Apr 09, 2013. After starting Aprovel Tabs 150 Mg the patient began experiencing various side effects, including: Hyperkalaemia, Renal Failure Acute, Dehydration, Anaemia, Femur FractureAdditional drugs used concurrently:
  • Coaprovel Tabs 150mg/12.5mg
  • Dalteparin Sodium (Anti Xa/0.2ml)
  • Tranxene (Hard Capsule)
  • Voltarene Emulgel (1df=1% Gel)
  • Amycor (1df=1% Cream)
  • Smecta
  • Sectral
  • Paracetamol
The patient was hospitalized. Although Aprovel Tabs 150 Mg demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hyperkalaemia, may still occur.
Aprovel Side Effect Report#9375382
Anaemia
This Anaemia problem was reported by a consumer or non-health professional from FR. A 40-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On 1983 this consumer started treatment with Aprovel Tabs 300 Mg (dosage: NA). The following drugs were being taken at the same time:
  • Kardegic (Powder For Oral Solution In Sachets)
  • Crestor (Tablet)
  • Levemir (Solution For Injection In Prefilled Pen (insulin Detemir))
  • Novorapid (1 Df : 10 U/ml. Solution For Injection In Prefilled Pen (insulin Asparte).)
When using Aprovel Tabs 300 Mg, the patient experienced the following unwanted symptoms/side effects: AnaemiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Anaemia, may become evident only after a product is in use by the general population.
Aprovel Side Effect Report#9370329
Renal Failure Acute, Diabetes Mellitus Inadequate Control, Bone Marrow Failure
This Renal Failure Acute side effect was reported by a consumer or non-health professional from FR. A 64-year-old male patient (weight:NA) experienced the following symptoms/conditions: hypertension.The patient was prescribed Aprovel Tabs 150 Mg (drug dosage: NA), which was initiated on
Dec 13, 2011. Concurrently used drugs:
  • Coaprovel (1df: Irbesartan 150 Mg + Hydrochlorothiazide 12.5 Mg)
  • Kidrolase
  • Methotrexate
  • Dexamethasone Acetate
.After starting to take Aprovel Tabs 150 Mg the consumer reported adverse symptoms, such as: Renal Failure Acute, Diabetes Mellitus Inadequate Control, Bone Marrow FailureThese side effects may potentially be related to Aprovel Tabs 150 Mg. The patient was hospitalized.
Aprovel Side Effect Report#9336979
Loss Of Consciousness, Wound, Fall, Orthostatic Hypotension, Malaise
This is a report of a 80-year-old female patient (weight: NA) from FR, suffering from the following health symptoms/conditions: hypertension,depression, who was treated with Aprovel Tabs 75 Mg (dosage: NA, start time: NS), combined with:
  • Laroxyl (Laroxyl 40 Mg/ml Oral Solution)
  • Seresta
and developed a serious reaction and side effect(s): Loss Of Consciousness, Wound, Fall, Orthostatic Hypotension, Malaise after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Aprovel Tabs 75 Mg treatment in female patients, resulting in Loss Of Consciousness side effect. The patient was hospitalized.


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The appearance of Aprovel 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 Aprovel Side Effects for Women?

Women Side EffectsReports
Hyponatraemia 28
Fall 23
Renal Failure Acute 19
Hyperkalaemia 18
Confusional State 17
Diarrhoea 15
Renal Failure 12
Blood Creatine Phosphokinase Increased 11
Anaemia 10
Dehydration 10

What are common Aprovel Side Effects for Men?

Men Side EffectsReports
Renal Failure Acute 29
Asthenia 14
Hyponatraemia 12
Renal Failure 10
Hyperkalaemia 9
Anaemia 8
Diarrhoea 8
Fall 8
Nausea 8
Dizziness 7

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.

    Aprovel 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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