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Aprovel Side Effects

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.

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.

Aprovel Side Effects Reported to FDA

The following 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.


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.
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 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). The consumer presented with:
  • Heart Disease Congenital
  • Maternal Exposure During Pregnancy
  • Pulmonary Artery Atresia
which developed 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.

Somnolence, Confusional State, Dysarthria
This report suggests a potential Aprovel Somnolence, Confusional State, Dysarthria 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. Soon after starting Aprovel the patient began experiencing various side effects, including:
  • Somnolence
  • Confusional State
  • Dysarthria
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.

Pancytopenia, Haemoglobin Decreased, Platelet Count Decreased
This Pancytopenia, Haemoglobin Decreased, Platelet Count Decreased 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 commencing Aprovel, the patient experienced the following unwanted symptoms/side effects:
  • Pancytopenia
  • Haemoglobin Decreased
  • Platelet Count Decreased
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 pancytopenia, may become evident only after a product is in use by the general population.

Thrombotic Stroke, Acute Myocardial Infarction, Hypokalaemia, Hyponatraemia
This is a report of a 88-year-old female patient (weight: NA) from CO. The patient developed the following symptoms/conditions: hypertension and was treated with Aprovel (dosage: NA) starting 2010. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Thrombotic Stroke
  • Acute Myocardial Infarction
  • Hypokalaemia
  • Hyponatraemia
The patient was hospitalized. This opens a possibility that Aprovel treatment could cause the above reactions, including thrombotic stroke, and some female subjects may be more susceptible.


Infarction
A 77-year-old female patient (weight: NA) from MX with the following symptoms/conditions: hypertension started Aprovel treatment (dosage: Strength: 150 Mg) on 2005. Soon after starting Aprovel treatment, the subject experienced various side effects, including:
  • Infarction
Concurrently used drugs: NA. This finding indicates that some female patients could be more vulnerable to Aprovel.

Dermatitis Bullous, Tremor, Pyrexia, Blister, Cough, Face Oedema
A 53-year-old patient from MY (weight: NA) experienced symptoms, such as: hypertension and was treated with Aprovel(dosage: NA). The treatment was initiated on NS. After that a consumer reported the following side effect(s):
  • Dermatitis Bullous
  • Tremor
  • Pyrexia
  • Blister
  • Cough
  • Face Oedema
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Aprovel efficacy:
  • Aspirin
  • Hydrochlorothiazide
  • Simvastatin
  • Bisoprolol
  • Isosorbide Mononitrate
  • Amlodipine


Weight Decreased, Type 1 Diabetes Mellitus, Hypercholesterolaemia, Autoimmune Hepatitis, Hepatitis Cholestatic, Sinus Tachycardia, Orthostatic Hypotension
In this report, Aprovel was administered for the following condition: hypertension,atrial fibrillation.A 71-year-old male consumer from FR (weight: NA) started Aprovel treatment (dosage: NA) on 200802.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Weight Decreased
  • Type 1 Diabetes Mellitus
  • Hypercholesterolaemia
  • Autoimmune Hepatitis
  • Hepatitis Cholestatic
  • Sinus Tachycardia
  • Orthostatic Hypotension
A possible interaction with other drugs could have contributed to this reaction:
  • Flecaine
The patient was hospitalized.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Aprovel treatment could be related to the listed above side effect(s).

Hyponatraemia
This is a report of the following Aprovel side effect(s):
  • Hyponatraemia
A 86-year-old female patient from ES (weight: NA) presented with the following condition: hypertension and received a treatment with Aprovel (dosage: NA) starting: 201211.The following concurrently used drugs could have generated interactions:
  • Mirtazapine
The patient was hospitalized.This report suggests that a Aprovel treatment could be associated with the listed above side effect(s).

Macular Oedema, Cataract
This Aprovel report was submitted by a 54-year-old male consumer from TN (weight: NA). The patient was diagnosed with: NA and Aprovel was administered (dosage: NA) starting: NS. The consumer developed a set of symptoms:
  • Macular Oedema
  • Cataract
Other drugs used simultaneously:
  • Amarel
  • Glucophage
  • Vildagliptin
Those unexpected symptoms could be linked to a Aprovel treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Vasculitis
This is a report of a possible correlation between Aprovel use and the following symptoms/side effect(s):
  • Vasculitis
which could contribute to an assessment of Aprovel risk profile.A 82-year-old female consumer from FR (weight: NA) was suffering from NA and was treated with Aprovel (dosage: Strength: 150 Mg) starting NS.Other concurrent medications: NA.

Tendonitis
A 62-year-old female patient from FR (weight: NA) presented with the following symptoms: hypertension and after a treatment with Aprovel (dosage: NA) experienced the following side effect(s):
  • Tendonitis
The treatment was started on 201304. Aprovel was used in combination with the following drugs: NA.This report could alert potential Aprovel consumers.

Hypertension, Type 2 Diabetes Mellitus
In this report, a 64-year-old female patient from MX (weight: NA) was affected by a possible Aprovel side effect.The patient was diagnosed with hypertension,osteoarthritis. After a treatment with Aprovel (dosage: NA, start date: 2007), the patient experienced the following side effect(s):
  • Hypertension
  • Type 2 Diabetes Mellitus
The following simultaneously used drugs could have led to this reaction:
  • Arcoxia (Strength: 90 Mg)
The findings here stress that side effects should be taken into consideration when evaluating a Aprovel treatment.

Acidosis Hyperchloraemic, Hyperkalaemia
This is a report of a 66-year-old female patient from IT (weight: NA), who used Aprovel (dosage: NA) for a treatment of hypertension. After starting a treatment on Sep 03, 2013, the patient experienced the following side effect(s):
  • Acidosis Hyperchloraemic
  • Hyperkalaemia
The following drugs could possibly have interacted with the Aprovel treatment
  • Kanrenol
  • Asa
  • Metformin Hydrochloride
  • Solosa
  • Competact (2 Posological Unit)
  • Totalip
  • Lyrica
The patient was hospitalized.Taken together, these observations suggest that a Aprovel treatment could be related to side effect(s), such as Acidosis Hyperchloraemic, Hyperkalaemia.

Pancreatitis Acute, Abdominal Pain, Diarrhoea
This pancreatitis acute side effect was reported by a health professional from FR. A 73-year-old male patient (weight:NA) experienced the following symptoms/conditions: hypertension,type 2 diabetes mellitus. The patient was prescribed Aprovel (dosage: NA), which was started on 2004. Concurrently used drugs:
  • Velmetia
  • Fludex
  • Detensiel
  • Previscan
  • Crestor
  • Amarel
When starting to take Aprovel the consumer reported the following symptoms:
  • Pancreatitis Acute
  • Abdominal Pain
  • Diarrhoea
The patient was hospitalized. These side effects may potentially be related to Aprovel.

Hypertension
This is a Aprovel side effect report of a 73-year-old male patient (weight:NA) from US, suffering from the following symptoms/conditions: hypertension, who was treated with Aprovel (dosage:Aprovel 150mg, start time: NS), combined with: NA., and developed a serious reaction and a hypertension side effect. The patient presented with:
  • Hypertension
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Aprovel treatment in male patients suffering from hypertension, resulting in hypertension.

Hyponatraemia, Hepatitis, Renal Failure Acute
This report suggests a potential Aprovel hyponatraemia side effect(s) that can have serious consequences. A 48-year-old male patient from FR (weight:NA) was diagnosed with the following health condition(s): hypertension and used Aprovel (dosage: NA) starting Jun 27, 2013. Soon after starting Aprovel the patient began experiencing various side effects, including:
  • Hyponatraemia
  • Hepatitis
  • Renal Failure Acute
Drugs used concurrently:
  • Lasilix
  • Zyloric
  • Ketum
  • Cordarone
  • Cardensiel
  • Previscan
  • Vitamin K
The patient was hospitalized. Although Aprovel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as hyponatraemia, may still occur.

Depression, Hyponatraemia, Blood Osmolarity Decreased, Malaise
This depression problem was reported by a health professional from FR. A 79-year-old male patient (weight: NA) was diagnosed with the following medical condition(s): hypertension.On Jul 18, 2013 a consumer started treatment with Aprovel (dosage: In Morning). The following drugs/medications were being taken at the same time:
  • 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
When commencing Aprovel, the patient experienced the following unwanted symptoms /side effects:
  • Depression
  • Hyponatraemia
  • Blood Osmolarity Decreased
  • Malaise
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 depression, may become evident only after a product is in use by the general population.

Dizziness, Nausea
This is a Aprovel side effect report of a 68-year-old male patient (weight: NA) from FR. The patient developed the following symptoms/conditions: hypertension,cerebrovascular accident and was treated with Aprovel (dosage: NA) starting Jun 10, 2013. Concurrently used drugs: NA. Soon after that, the consumer experienced the following of symptoms:
  • Dizziness
  • Nausea
This opens a possibility that Aprovel could cause dizziness and that some male patients may be more susceptible.

Fall
A 94-year-old female patient (weight: NA) from FR with the following symptoms: NA started Aprovel Film-coated Tabs 150 Mg treatment (dosage: NA) on Mar 28, 2013. Soon after starting Aprovel Film-coated Tabs 150 Mg treatment, the consumer experienced several side effects, including:
  • Fall
. Concurrently used drugs:
  • Alprazolam (Scored Tablet)
  • Doliprane (500 Mg Tabs)
  • Imovane (Film-coated Scored Tablet)
  • Mianserin (Film-coated Scored Tablet)
  • Lasilix Faible
  • Gelox
  • Lansoyl
  • Transipeg
This finding indicates that some patients can be more vulnerable to developing Aprovel Film-coated Tabs 150 Mg side effects, such as fall.

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 (dosage: NA), which was started on NS. Concurrently used drugs: NA..When starting to take Aprovel the consumer reported symptoms, such as:
  • Umbilical Hernia
These side effects may potentially be related to Aprovel.

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 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). The consumer presented with:
  • Carotid Artery Stenosis
  • Cerebrovascular Accident
  • Dizziness
which developed 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.

Hyperkalaemia, Renal Failure Acute, Dehydration, Anaemia, Femur Fracture
This report suggests a potential Aprovel Tabs 150 Mg Hyperkalaemia, Renal Failure Acute, Dehydration, Anaemia, Femur Fracture 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. Soon after starting Aprovel Tabs 150 Mg the patient began experiencing various side effects, including:
  • Hyperkalaemia
  • Renal Failure Acute
  • Dehydration
  • Anaemia
  • Femur Fracture
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.

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 commencing Aprovel Tabs 300 Mg, the patient experienced the following unwanted symptoms/side effects:
  • Anaemia
Although 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.

Renal Failure Acute, Diabetes Mellitus Inadequate Control, Bone Marrow Failure
This is a report of a 64-year-old male patient (weight: NA) from FR. The patient developed the following symptoms/conditions: hypertension and was treated with Aprovel Tabs 150 Mg (dosage: NA) starting Dec 13, 2011. Concurrently used drugs:
  • Coaprovel (1df: Irbesartan 150 Mg + Hydrochlorothiazide 12.5 Mg)
  • Kidrolase
  • Methotrexate
  • Dexamethasone Acetate
Soon after that, the consumer experienced the following side effects:
  • Renal Failure Acute
  • Diabetes Mellitus Inadequate Control
  • Bone Marrow Failure
The patient was hospitalized. This opens a possibility that Aprovel Tabs 150 Mg treatment could cause the above reactions, including renal failure acute, and some male subjects may be more susceptible.

Loss Of Consciousness, Wound, Fall, Orthostatic Hypotension, Malaise
A 80-year-old female patient (weight: NA) from FR with the following symptoms/conditions: hypertension,depression started Aprovel Tabs 75 Mg treatment (dosage: NA) on NS. Soon after starting Aprovel Tabs 75 Mg treatment, the subject experienced various side effects, including:
  • Loss Of Consciousness
  • Wound
  • Fall
  • Orthostatic Hypotension
  • Malaise
Concurrently used drugs:
  • Laroxyl (Laroxyl 40 Mg/ml Oral Solution)
  • Seresta
The patient was hospitalized. This finding indicates that some female patients could be more vulnerable to Aprovel Tabs 75 Mg.

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Top 10 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

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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