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Benicar Side Effects

PatientsVille

Common Benicar Side Effects


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

Hypotension (124)
Diarrhoea (124)
Dizziness (122)
Blood Pressure Increased (110)
Nausea (99)
Weight Decreased (84)
Dehydration (77)
Headache (76)
Asthenia (72)
Vomiting (71)
Fatigue (62)
Hypertension (55)
Coeliac Disease (54)
Dyspnoea (54)
Oedema Peripheral (49)
Fall (44)
Cerebrovascular Accident (41)
Malaise (35)
Insomnia (34)
Pruritus (33)

➢ 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.

Benicar Side Effects Reported to FDA



Benicar Side Effect Report#9995304
Angina Pectoris
This is a report of a 65-year-old male patient (weight: NA) from BR, suffering from the following health symptoms/conditions: hypertension, who was treated with Benicar (dosage: NA, start time: NS), combined with:
  • Hydralazine (hydralazine) (hydralazine)
and developed a serious reaction and side effect(s): Angina Pectoris after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Benicar treatment in male patients, resulting in Angina Pectoris side effect. The patient was hospitalized.
Benicar Side Effect Report#9986056
Colitis
This report suggests a potential Benicar Colitis side effect(s) that can have serious consequences. A 74-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: cardiac disorder,blood pressure and used Benicar (dosage: NA) starting 201107. After starting Benicar the patient began experiencing various side effects, including: ColitisAdditional drugs used concurrently:
  • Toprol
  • Toprol
  • Aspirin
  • Simvastatin
  • Humira
  • Humira
Although Benicar demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Colitis, may still occur.
Benicar Side Effect Report#9971702
Fall, Thyroid Disorder, Femur Fracture, Pain In Extremity, Oedema Peripheral, Bedridden, Dysstasia, Device Related Infection, Urinary Tract Infection
This Fall problem was reported by a consumer or non-health professional from BR. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: hypertension. On 2013 this consumer started treatment with Benicar Anlo (dosage: 1 In 1 D). The following drugs were being taken at the same time:
  • Citalopram (citalopram) (citalopram)
  • Omeprazole (omeprazole) (omeprazole)
  • Strontion Ranelate
  • Bromazepam (bromazepam) (bromazepam)
When using Benicar Anlo, the patient experienced the following unwanted symptoms/side effects: Fall, Thyroid Disorder, Femur Fracture, Pain In Extremity, Oedema Peripheral, Bedridden, Dysstasia, Device Related Infection, Urinary Tract InfectionThe 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 Fall, may become evident only after a product is in use by the general population.
Benicar Side Effect Report#9970141
Urinary Retention, Chest Pain, Fatigue, Abdominal Distension, Pneumonia, Urinary Tract Infection
This Urinary Retention side effect was reported by a consumer or non-health professional from BR. A 77-year-old female patient (weight:NA) experienced the following symptoms/conditions: hypertension.The patient was prescribed Benicar (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Effient
  • Levothyroxine Sodium (levothyroxine Sodium)
  • Ezetimibe/simvastatin (simvastatin Ezetimibe) (simvastatin, Ezetimibe)
  • Folic Acid (folic Acid) (folic Acid)
  • Pantoprazole (pantoprazole) (pantoprazole)
  • Senna/casia Fistula/tamarindus Indica/coriandrum Sativum/glycerhiza Glabra
  • Bluclizine (buclizine) (buclizine)
.After starting to take Benicar the consumer reported adverse symptoms, such as: Urinary Retention, Chest Pain, Fatigue, Abdominal Distension, Pneumonia, Urinary Tract InfectionThese side effects may potentially be related to Benicar. The patient was hospitalized.
Benicar Side Effect Report#9970029
Hypertension, Dizziness, Catheter Placement
This is a report of a 64-year-old female patient (weight: NA) from BR, suffering from the following health symptoms/conditions: hypertension, who was treated with Benicar (dosage: 1 In 1 D, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Hypertension, Dizziness, Catheter Placement after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Benicar treatment in female patients, resulting in Hypertension side effect.
Benicar Side Effect Report#9969621
Renal Failure Acute, Dehydration, Colitis Microscopic
This report suggests a potential Benicar Renal Failure Acute side effect(s) that can have serious consequences. A 74-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: hypertension and used Benicar (dosage: 1 Tablet, Qd, Oral) starting
May 30, 2009. After starting Benicar the patient began experiencing various side effects, including: Renal Failure Acute, Dehydration, Colitis MicroscopicAdditional drugs used concurrently:
  • Clonidine
  • Vitamin D3
  • Calcium Citrate
  • Mirtazapine
  • Omeprazole
  • Nitrostat
  • Docusate
  • Trental
The patient was hospitalized and became disabled. Although Benicar demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Renal Failure Acute, may still occur.
Benicar Side Effect Report#9922440
Dyspnoea, Fatigue
This Dyspnoea problem was reported by a consumer or non-health professional from US. A 49-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: blood potassium decreased,blood pressure fluctuation. On
Dec 16, 2013 this consumer started treatment with Benicar (dosage: 1 Pill Twice Daily). The following drugs were being taken at the same time: NA. When using Benicar, the patient experienced the following unwanted symptoms/side effects: Dyspnoea, FatigueAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Dyspnoea, may become evident only after a product is in use by the general population.
Benicar Side Effect Report#9913512
Fall, Finger Amputation, Limb Injury, Sinusitis, Economic Problem, Skin Injury, Limb Injury
This Fall side effect was reported by a consumer or non-health professional from US. A 67-year-old female patient (weight:NA) experienced the following symptoms/conditions: hypertension.The patient was prescribed Benicar Hct (drug dosage: 40/25mg (qd), Per Oral), which was initiated on NS. Concurrently used drugs:
  • Atorvastatin (atorvastatin)
  • Glucosamine (glucosamine)
.After starting to take Benicar Hct the consumer reported adverse symptoms, such as: Fall, Finger Amputation, Limb Injury, Sinusitis, Economic Problem, Skin Injury, Limb InjuryThese side effects may potentially be related to Benicar Hct.
Benicar Side Effect Report#9912688
Asthenia, Anxiety, Cachexia, Dysphagia, Abnormal Behaviour, Tremor, Transient Ischaemic Attack, Eye Movement Disorder
This is a report of a female patient (weight: NA) from BR, suffering from the following health symptoms/conditions: hypertension, who was treated with Benicar (dosage: NA, start time: 2011), combined with:
  • Amlodipine (amlodipine) (amlodipine)
  • Cilostazol (cilostazol) (cilostazol)
  • Glimepiride (glimepiride) (glimepiride)
  • Vitaminc (ascorbic Acid) (ascorbic Acid)
  • Olanzapine (olanzapine) (olanzapine)
and developed a serious reaction and side effect(s): Asthenia, Anxiety, Cachexia, Dysphagia, Abnormal Behaviour, Tremor, Transient Ischaemic Attack, Eye Movement Disorder after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Benicar treatment in female patients, resulting in Asthenia side effect. The patient was hospitalized.
Benicar Side Effect Report#9905249
Intervertebral Disc Protrusion, Weight Decreased, Abdominal Pain Upper, Blood Pressure Increased, Condition Aggravated
This report suggests a potential Benicar (olmesartan Medoxomil) (tablet) (olmesartan Medoxomil) Intervertebral Disc Protrusion side effect(s) that can have serious consequences. A 52-year-old female patient (weight: NA) from BR was diagnosed with the following symptoms/conditions: hypertension and used Benicar (olmesartan Medoxomil) (tablet) (olmesartan Medoxomil) (dosage: 20 Mg, 1 In 1 D) starting
Jan 13, 2010. After starting Benicar (olmesartan Medoxomil) (tablet) (olmesartan Medoxomil) the patient began experiencing various side effects, including: Intervertebral Disc Protrusion, Weight Decreased, Abdominal Pain Upper, Blood Pressure Increased, Condition AggravatedAdditional drugs used concurrently:
  • Omeprazole
  • Omega
The patient was hospitalized. Although Benicar (olmesartan Medoxomil) (tablet) (olmesartan Medoxomil) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Intervertebral Disc Protrusion, may still occur.
Benicar Side Effect Report#9880809
Dizziness, Orthostatic Hypotension, Balance Disorder, Vision Blurred, Muscle Spasms, Hypercholesterolaemia, Influenza, Sinusitis, Aggression
This Dizziness problem was reported by a consumer or non-health professional from BR. A 57-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: hypertension,sinusitis. On 201305 this consumer started treatment with Benicar (olmesartan Medoxomil) (tablet) (olmesartan Medoxomil) (dosage: NA). The following drugs were being taken at the same time:
  • Prednisolone (prednisolone)
  • Benicar Hct (hydrochlorothiazide, Olmesartan Medoxomil) (tablet) (hydrochlorothiazide, Olmesartan Me
  • Moxifloxacin
  • Levothyroxine Sodium (levothyroxine Sodium)
  • Paroxetine (paroxetine)
  • Ezetimibe (ezetimibe)
When using Benicar (olmesartan Medoxomil) (tablet) (olmesartan Medoxomil), the patient experienced the following unwanted symptoms/side effects: Dizziness, Orthostatic Hypotension, Balance Disorder, Vision Blurred, Muscle Spasms, Hypercholesterolaemia, Influenza, Sinusitis, AggressionThe 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 Dizziness, may become evident only after a product is in use by the general population.
Benicar Side Effect Report#9866841
Weight Decreased, Coeliac Disease, Dehydration, Blood Pressure Increased, Impaired Work Ability, Nephrolithiasis, Gout, Transient Ischaemic Attack, Cerebrovascular Accident
This Weight Decreased side effect was reported by a consumer or non-health professional from US. A 66-year-old male patient (weight:NA) experienced the following symptoms/conditions: hypertension.The patient was prescribed Benicar (drug dosage: 1 Pill Per Day Once Daily Taken By Mouth), which was initiated on
Jun 30, 2006. Concurrently used drugs: NA..After starting to take Benicar the consumer reported adverse symptoms, such as: Weight Decreased, Coeliac Disease, Dehydration, Blood Pressure Increased, Impaired Work Ability, Nephrolithiasis, Gout, Transient Ischaemic Attack, Cerebrovascular AccidentThese side effects may potentially be related to Benicar. The patient was hospitalized.
Benicar Side Effect Report#9859133
Breast Cancer, Tachycardia, Blood Cholesterol Abnormal
This is a report of a 69-year-old female patient (weight: NA) from BR, suffering from the following health symptoms/conditions: hypertension,arrhythmia,blood pressure,breast cancer,blood cholesterol, who was treated with Benicar Hct (dosage: 1 Dosage Forms (1 Dosage Forms, Qd), Per Oral, start time: 2012), combined with:
  • Atenolol (atenolol) (atenolol)
  • Atenolol (atenolol) (atenolol)
  • Festone (1 Dosage Forms (1 Dosage Forms, Qd)?)
  • Crestor
and developed a serious reaction and side effect(s): Breast Cancer, Tachycardia, Blood Cholesterol Abnormal after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Benicar Hct treatment in female patients, resulting in Breast Cancer side effect. The patient was hospitalized.
Benicar Side Effect Report#9856901
Myocardial Infarction, Unevaluable Event
This report suggests a potential Benicar Myocardial Infarction side effect(s) that can have serious consequences. A 68-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: hypertension and used Benicar (dosage: NA) starting NS. After starting Benicar the patient began experiencing various side effects, including: Myocardial Infarction, Unevaluable EventAdditional drugs used concurrently:
  • Crestor (rosuvastatin) (rosuvastatin)
Although Benicar demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Myocardial Infarction, may still occur.
Benicar Side Effect Report#9852342
Haemorrhage
This Haemorrhage problem was reported by a consumer or non-health professional from US. A 47-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: hypertension. On NS this consumer started treatment with Benicar (dosage: NA). The following drugs were being taken at the same time: NA. When using Benicar, the patient experienced the following unwanted symptoms/side effects: HaemorrhageAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Haemorrhage, may become evident only after a product is in use by the general population.
Benicar Side Effect Report#9849883
Nasopharyngitis, Oedema, Oedema Peripheral, Thrombosis, Tendonitis, Pain, Chest Pain, Nasopharyngitis, Pyrexia
This Nasopharyngitis side effect was reported by a consumer or non-health professional from BR. A female patient (weight:NA) experienced the following symptoms/conditions: hypertension.The patient was prescribed Benicar Anlo (olmesartan Medoxomil, Amlodipine Besilate) (tablet) (olmesartan Medoxomil, Amlodipine) (drug dosage: 80/10 Mg (1 In 1 D, Per Oral), which was initiated on 2013. Concurrently used drugs:
  • Tacrolimus (tacrolimus) (tacrolimus)
  • Mycophenolate (mycophenolate Mofetil) (mycophenolate Mofetil)
  • Ferrous Sulphate (ferrous Sulfate) (ferrous Sulfate)
  • Vitamin B1/vitamin B2/vitaminb3/vitamin B6/vitamin B5
.After starting to take Benicar Anlo (olmesartan Medoxomil, Amlodipine Besilate) (tablet) (olmesartan Medoxomil, Amlodipine) the consumer reported adverse symptoms, such as: Nasopharyngitis, Oedema, Oedema Peripheral, Thrombosis, Tendonitis, Pain, Chest Pain, Nasopharyngitis, PyrexiaThese side effects may potentially be related to Benicar Anlo (olmesartan Medoxomil, Amlodipine Besilate) (tablet) (olmesartan Medoxomil, Amlodipine). The patient was hospitalized.
Benicar Side Effect Report#9846543
Blood Pressure Increased, Fear Of Disease, Influenza, Arthralgia, Fatigue, Tremor, Stress, Blood Cortisol Decreased, Weight Decreased
This is a report of a 68-year-old female patient (weight: NA) from BR, suffering from the following health symptoms/conditions: hypertension, who was treated with Benicar Hct (dosage: NA, start time: 201308), combined with:
  • Rosuvastatin (rosuvastatin)
  • Fenofibrate (fenofibrate)
  • Formoterol Fumarate/budesonide (formoterol Fumarate, Budesonide)
  • Bupropion Hydrochloride
  • Clonazepam (clonazepam)
  • Acetylsalicylic Acid (acetylsalicylic Acid)
  • Anti-inflammatory For Pain Knee
and developed a serious reaction and side effect(s): Blood Pressure Increased, Fear Of Disease, Influenza, Arthralgia, Fatigue, Tremor, Stress, Blood Cortisol Decreased, Weight Decreased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Benicar Hct treatment in female patients, resulting in Blood Pressure Increased side effect.
Benicar Side Effect Report#9844988
Fatigue, Nausea, Abdominal Distension, Decreased Appetite, Gastroenteritis Viral, Vomiting, Diarrhoea, Hypotension, Lactose Intolerance
This report suggests a potential Benicar Fatigue side effect(s) that can have serious consequences. A 78-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: hypertension and used Benicar (dosage: NA) starting
Jan 17, 2013. After starting Benicar the patient began experiencing various side effects, including: Fatigue, Nausea, Abdominal Distension, Decreased Appetite, Gastroenteritis Viral, Vomiting, Diarrhoea, Hypotension, Lactose IntoleranceAdditional drugs used concurrently: NA.The patient was hospitalized and became disabled. Although Benicar demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Fatigue, may still occur.
Benicar Side Effect Report#9838618
Obesity, Blood Glucose Increased, Paraesthesia, Abdominal Pain Upper, Weight Decreased, Aortic Disorder, Pancreatic Neoplasm, Pallor, Pain In Extremity
This Obesity problem was reported by a consumer or non-health professional from BR. A patient (weight: NA) was diagnosed with the following symptoms/conditions: hypertension,abdominal pain upper. On 201311 this consumer started treatment with Benicar (dosage: 40 Mg (1 In 1 D), Per Oral). The following drugs were being taken at the same time:
  • Morphine
  • Lanzoprazole
  • Aluminum Hydroxide (aluminum Hydroxide) (aluminum Hydroxide)
  • Medicines For Small Fatty Deposits In Less Than 30% Of The Brai
When using Benicar, the patient experienced the following unwanted symptoms/side effects: Obesity, Blood Glucose Increased, Paraesthesia, Abdominal Pain Upper, Weight Decreased, Aortic Disorder, Pancreatic Neoplasm, Pallor, Pain In ExtremityThe 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 Obesity, may become evident only after a product is in use by the general population.
Benicar Side Effect Report#9821406
Diarrhoea, Weight Decreased, Intestinal Villi Atrophy
This Diarrhoea side effect was reported by a consumer or non-health professional from US. A 80-year-old female patient (weight:NA) experienced the following symptoms/conditions: hypertension.The patient was prescribed Benicar (drug dosage: Once Daily), which was initiated on NS. Concurrently used drugs: NA..After starting to take Benicar the consumer reported adverse symptoms, such as: Diarrhoea, Weight Decreased, Intestinal Villi AtrophyThese side effects may potentially be related to Benicar.
Benicar Side Effect Report#9815772
Skin Ulcer, Peripheral Vascular Disorder, Toe Amputation
This is a report of a 76-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: hypertension, who was treated with Benicar (dosage: NA, start time: NS), combined with:
  • Benicar Hct (hydrochlorothiazide, Olmesartan Medoxomil) (tablet) (hydrochlorothiazide, Olmesartan Me
and developed a serious reaction and side effect(s): Skin Ulcer, Peripheral Vascular Disorder, Toe Amputation after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Benicar treatment in male patients, resulting in Skin Ulcer side effect. The patient was hospitalized.
Benicar Side Effect Report#9789703
Osteoarthritis, Knee Operation
This report suggests a potential Benicar Hct Osteoarthritis side effect(s) that can have serious consequences. A female patient (weight: NA) from BR was diagnosed with the following symptoms/conditions: hypertension and used Benicar Hct (dosage: 20/12.5 Mg (1 In 1 D), Per Oral) starting 2005. After starting Benicar Hct the patient began experiencing various side effects, including: Osteoarthritis, Knee OperationAdditional drugs used concurrently:
  • Pantoprazole
  • Evothyroxine Sodium (levothyroxine Sodium)
  • Loratadine
  • Domperidone
The patient was hospitalized. Although Benicar Hct demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Osteoarthritis, may still occur.
Benicar Side Effect Report#9786274
Pruritus, Angioedema, Glucose Tolerance Impaired, Peripheral Vascular Disorder, Nervous System Disorder, Oedema Peripheral, Diverticulitis, Hyperglycaemia
This Pruritus problem was reported by a consumer or non-health professional from BR. A male patient (weight: NA) was diagnosed with the following symptoms/conditions: hypertension,feeling hot. On 2012 this consumer started treatment with Benicar (dosage: NA). The following drugs were being taken at the same time:
  • Medicine
When using Benicar, the patient experienced the following unwanted symptoms/side effects: Pruritus, Angioedema, Glucose Tolerance Impaired, Peripheral Vascular Disorder, Nervous System Disorder, Oedema Peripheral, Diverticulitis, HyperglycaemiaThe 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 Pruritus, may become evident only after a product is in use by the general population.
Benicar Side Effect Report#9767827
Pyrexia, Sleep Apnoea Syndrome, Thyroid Neoplasm, Blood Pressure Increased
This Pyrexia side effect was reported by a consumer or non-health professional from US. A 71-year-old male patient (weight:NA) experienced the following symptoms/conditions: hypertension.The patient was prescribed Benicar (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Vitamin D (ergocalciferol)
  • Multivitamin (ascorbic Acid, Pyridoxine Hydrochloride, Thiamine Hydrochloride, Colecalciferol, Retin
.After starting to take Benicar the consumer reported adverse symptoms, such as: Pyrexia, Sleep Apnoea Syndrome, Thyroid Neoplasm, Blood Pressure IncreasedThese side effects may potentially be related to Benicar.
Benicar Side Effect Report#9747687
Gastrointestinal Disorder, Diarrhoea, Inflammatory Bowel Disease
This is a report of a 70-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: hypertension, who was treated with Benicar (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Gastrointestinal Disorder, Diarrhoea, Inflammatory Bowel Disease after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Benicar treatment in male patients, resulting in Gastrointestinal Disorder side effect.

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The appearance of Benicar 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.


What are common Benicar Side Effects for Women?

Women Side EffectsReports
Diarrhoea 81
Hypotension 77
Blood Pressure Increased 71
Nausea 69
Dizziness 62
Headache 55
Asthenia 49
Vomiting 48
Fatigue 45
Dehydration 43

What are common Benicar Side Effects for Men?

Men Side EffectsReports
Dizziness 60
Hypotension 46
Weight Decreased 43
Diarrhoea 42
Blood Pressure Increased 39
Dehydration 34
Nausea 29
Asthenia 22
Vomiting 22
Syncope 21

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.

    Benicar 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.

    Discuss Benicar Side Effects

    Did You Have a Benicar Side Effect?

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    How Effective is Benicar for You?

    Exceeded Expectations
    Effective
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    Benicar Safety Alerts, Active Ingredients, Usage Information

    NDC35356-216
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameBenicar
    Nameolmesartan medoxomil
    Dosage FormTABLET, FILM COATED
    RouteORAL
    On market since20120222
    LabelerLake Erie Medical & Surgical Supply DBA Quality Care Products LLC
    Active Ingredient(s)OLMESARTAN MEDOXOMIL
    Strength(s)40
    Unit(s)mg/1
    Pharma ClassAngiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]

    Benicar Dosage, Warnings, Usage.

    Side Effects reported to FDA: 1395

    Benicar safety alerts: 2010

    Reported deaths: 35

    Reported hospitalizations: 435

    Benicar (olmesartan): Ongoing Safety Review

    [UPDATED 04/14/2011] After reviewing the results of the ROADMAP and ORIENT trials, FDA has determined that the benefits of Benicar continue to outweigh its potential risks when used for the treatment of patients with high blood pressure according to the drug label. Benicar is not recommended as a treatment to delay or prevent protein in the urine (microalbuminuria) in diabetic patients.

    Patients should consult their healthcare professional if they have any questions or concerns about taking Benicar.

    Daiichi Sankyo, the makers of Benicar, have agreed to work with the FDA to perform additional studies, as well as conduct additional analyses of completed clinical studies, to obtain more complete information about the cardiovascular risks or benefits of Benicar in various clinical settings. FDA will update the public when new information is available.

     

    Audience: Cardiology, Internal Medicine

    [Posted 06/11/2010]

    ISSUE: FDA is evaluating data from two clinical trials in which patients with type 2 diabetes taking the blood pressure medication, Benicar (olmesartan), an angiotensin II receptor blocker, had a higher rate of death from a cardiovascular cause compared to patients taking a placebo. FDA's review is ongoing and the Agency has not concluded that Benicar increases the risk of death. FDA currently believes that the benefits of Benicar in patients with high blood pressure continue to outweigh its potential risks.

    BACKGROUND: The Agency plans to review the primary data from the two studies of concern, ROADMAP and ORIENT, and is considering additional ways to assess the cardiovascular effects of Benicar. ROADMAP and ORIENT are both long-term clinical trials. In both trials, patients with type 2 diabetes were given either Benicar or placebo to determine if treatment with Benicar would slow the progression of kidney disease. An unexpected finding observed in both trials was a greater number of deaths from a cardiovascular cause (heart attack, sudden death, or stroke) in the Benicar-treated patients compared to placebo.

    RECOMMENDATION: Follow the recommendations in the drug label when prescribing Benicar. Additional Information for Patients, for Healthcare Professionals and a Data Summary are provided in the Drug Safety Communication below. Additional information about ROADMAP and ORIENT can be found at clinicaltrials.gov.

    Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

    • Online: www.fda.gov/MedWatch/report.htm
    • Phone: 1-800-332-1088
    • Mail: return the postage-paid FDA form 3500, which may be downloaded from the MedWatch "Download Forms" page, to address on the pre-addressed form
    • Fax: 1-800-FDA-0178

     

    [04/14/2011 - Drug Safety Communication - FDA] 
    [06/11/2010 - Drug Safety Communication - FDA]

    Latest Benicar clinical trials