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Benicar Side Effects

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.

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.

Benicar Side Effects Reported to FDA

The following 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.


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.
Angina Pectoris
This is a report of a 65-year-old male patient (weight: NA) from BR, suffering from the following 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). The consumer presented with:
  • Angina Pectoris
which developed 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.

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. Soon after starting Benicar the patient began experiencing various side effects, including:
  • Colitis
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.

Fall, Thyroid Disorder, Femur Fracture, Pain In Extremity, Oedema Peripheral, Bedridden, Dysstasia, Device Related Infection, Urinary Tract Infection
This Fall, Thyroid Disorder, Femur Fracture, Pain In Extremity, Oedema Peripheral, Bedridden, Dysstasia, Device Related Infection, Urinary Tract Infection 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 commencing 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 Infection
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 fall, may become evident only after a product is in use by the general population.

Urinary Retention, Chest Pain, Fatigue, Abdominal Distension, Pneumonia, Urinary Tract Infection
This is a report of a 77-year-old female patient (weight: NA) from BR. The patient developed the following symptoms/conditions: hypertension and was treated with Benicar (dosage: NA) starting 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)
Soon after that, the consumer experienced the following side effects:
  • Urinary Retention
  • Chest Pain
  • Fatigue
  • Abdominal Distension
  • Pneumonia
  • Urinary Tract Infection
The patient was hospitalized. This opens a possibility that Benicar treatment could cause the above reactions, including urinary retention, and some female subjects may be more susceptible.


Hypertension, Dizziness, Catheter Placement
A 64-year-old female patient (weight: NA) from BR with the following symptoms/conditions: hypertension started Benicar treatment (dosage: 1 In 1 D) on NS. Soon after starting Benicar treatment, the subject experienced various side effects, including:
  • Hypertension
  • Dizziness
  • Catheter Placement
Concurrently used drugs: NA. This finding indicates that some female patients could be more vulnerable to Benicar.

Renal Failure Acute, Dehydration, Colitis Microscopic
A 74-year-old female patient from US (weight: NA) experienced symptoms, such as: hypertension and was treated with Benicar(dosage: 1 Tablet, Qd, Oral). The treatment was initiated on May 30, 2009. After that a consumer reported the following side effect(s):
  • Renal Failure Acute
  • Dehydration
  • Colitis Microscopic
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Benicar efficacy:
  • Clonidine
  • Vitamin D3
  • Calcium Citrate
  • Mirtazapine
  • Omeprazole
  • Nitrostat
  • Docusate
  • Trental
The patient was hospitalized and became disabled.

Dyspnoea, Fatigue
In this report, Benicar was administered for the following condition: blood potassium decreased,blood pressure fluctuation.A 49-year-old female consumer from US (weight: NA) started Benicar treatment (dosage: 1 Pill Twice Daily) on Dec 16, 2013.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Dyspnoea
  • Fatigue
A possible interaction with other drugs could have contributed to this reaction: NA.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Benicar treatment could be related to the listed above side effect(s).

Fall, Finger Amputation, Limb Injury, Sinusitis, Economic Problem, Skin Injury
This is a report of the following Benicar Hct side effect(s):
  • Fall
  • Finger Amputation
  • Limb Injury
  • Sinusitis
  • Economic Problem
  • Skin Injury
A 67-year-old female patient from US (weight: NA) presented with the following condition: hypertension and received a treatment with Benicar Hct (dosage: 40/25mg (qd), Per Oral) starting: NS.The following concurrently used drugs could have generated interactions:
  • Atorvastatin (atorvastatin)
  • Glucosamine (glucosamine)
This report suggests that a Benicar Hct treatment could be associated with the listed above side effect(s).

Asthenia, Anxiety, Cachexia, Dysphagia, Abnormal Behaviour, Tremor, Transient Ischaemic Attack, Eye Movement Disorder
This Benicar report was submitted by a female consumer from BR (weight: NA). The patient was diagnosed with: hypertension and Benicar was administered (dosage: NA) starting: 2011. The consumer developed a set of symptoms:
  • Asthenia
  • Anxiety
  • Cachexia
  • Dysphagia
  • Abnormal Behaviour
  • Tremor
  • Transient Ischaemic Attack
  • Eye Movement Disorder
Other drugs used simultaneously:
  • Amlodipine (amlodipine) (amlodipine)
  • Cilostazol (cilostazol) (cilostazol)
  • Glimepiride (glimepiride) (glimepiride)
  • Vitaminc (ascorbic Acid) (ascorbic Acid)
  • Olanzapine (olanzapine) (olanzapine)
The patient was hospitalized.Those unexpected symptoms could be linked to a Benicar treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Intervertebral Disc Protrusion, Weight Decreased, Abdominal Pain Upper, Blood Pressure Increased, Condition Aggravated
This is a report of a possible correlation between Benicar (olmesartan Medoxomil) (tablet) (olmesartan Medoxomil) use and the following symptoms/side effect(s):
  • Intervertebral Disc Protrusion
  • Weight Decreased
  • Abdominal Pain Upper
  • Blood Pressure Increased
  • Condition Aggravated
which could contribute to an assessment of Benicar (olmesartan Medoxomil) (tablet) (olmesartan Medoxomil) risk profile.A 52-year-old female consumer from BR (weight: NA) was suffering from hypertension and was treated with Benicar (olmesartan Medoxomil) (tablet) (olmesartan Medoxomil) (dosage: 20 Mg, 1 In 1 D) starting Jan 13, 2010.Other concurrent medications:
  • Omeprazole
  • Omega
The patient was hospitalized.

Dizziness, Orthostatic Hypotension, Balance Disorder, Vision Blurred, Muscle Spasms, Hypercholesterolaemia, Influenza, Sinusitis, Aggression
A 57-year-old female patient from BR (weight: NA) presented with the following symptoms: hypertension,sinusitis and after a treatment with Benicar (olmesartan Medoxomil) (tablet) (olmesartan Medoxomil) (dosage: NA) experienced the following side effect(s):
  • Dizziness
  • Orthostatic Hypotension
  • Balance Disorder
  • Vision Blurred
  • Muscle Spasms
  • Hypercholesterolaemia
  • Influenza
  • Sinusitis
  • Aggression
The treatment was started on 201305. Benicar (olmesartan Medoxomil) (tablet) (olmesartan Medoxomil) was used in combination with the following drugs:
  • Prednisolone (prednisolone)
  • Benicar Hct (hydrochlorothiazide, Olmesartan Medoxomil) (tablet) (hydrochlorothiazide, Olmesartan Me
  • Moxifloxacin
  • Levothyroxine Sodium (levothyroxine Sodium)
  • Paroxetine (paroxetine)
  • Ezetimibe (ezetimibe)
The patient was hospitalized.This report could alert potential Benicar (olmesartan Medoxomil) (tablet) (olmesartan Medoxomil) consumers.

Weight Decreased, Coeliac Disease, Dehydration, Blood Pressure Increased, Impaired Work Ability, Nephrolithiasis, Gout, Transient Ischaemic Attack, Cerebrovascular Accident
In this report, a 66-year-old male patient from US (weight: NA) was affected by a possible Benicar side effect.The patient was diagnosed with hypertension. After a treatment with Benicar (dosage: 1 Pill Per Day Once Daily Taken By Mouth, start date: Jun 30, 2006), the patient experienced the following side effect(s):
  • Weight Decreased
  • Coeliac Disease
  • Dehydration
  • Blood Pressure Increased
  • Impaired Work Ability
  • Nephrolithiasis
  • Gout
  • Transient Ischaemic Attack
  • Cerebrovascular Accident
The following simultaneously used drugs could have led to this reaction: NA.The patient was hospitalized.The findings here stress that side effects should be taken into consideration when evaluating a Benicar treatment.

Breast Cancer, Tachycardia, Blood Cholesterol Abnormal
This is a report of a 69-year-old female patient from BR (weight: NA), who used Benicar Hct (dosage: 1 Dosage Forms (1 Dosage Forms, Qd), Per Oral) for a treatment of hypertension,arrhythmia,blood pressure,breast cancer,blood cholesterol. After starting a treatment on 2012, the patient experienced the following side effect(s):
  • Breast Cancer
  • Tachycardia
  • Blood Cholesterol Abnormal
The following drugs could possibly have interacted with the Benicar Hct treatment
  • Atenolol (atenolol) (atenolol)
  • Atenolol (atenolol) (atenolol)
  • Festone (1 Dosage Forms (1 Dosage Forms, Qd)?)
  • Crestor
The patient was hospitalized.Taken together, these observations suggest that a Benicar Hct treatment could be related to side effect(s), such as Breast Cancer, Tachycardia, Blood Cholesterol Abnormal.

Myocardial Infarction, Unevaluable Event
This myocardial infarction side effect was reported by a physician from US. A 68-year-old male patient (weight:NA) experienced the following symptoms/conditions: hypertension. The patient was prescribed Benicar (dosage: NA), which was started on NS. Concurrently used drugs:
  • Crestor (rosuvastatin) (rosuvastatin)
When starting to take Benicar the consumer reported the following symptoms:
  • Myocardial Infarction
  • Unevaluable Event
These side effects may potentially be related to Benicar.

Haemorrhage
This is a Benicar side effect report of a 47-year-old male patient (weight:NA) from US, suffering from the following symptoms/conditions: hypertension, who was treated with Benicar (dosage:NA, start time: NS), combined with: NA., and developed a serious reaction and a haemorrhage side effect. The patient presented with:
  • Haemorrhage
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Benicar treatment in male patients suffering from hypertension, resulting in haemorrhage.

Nasopharyngitis, Oedema, Oedema Peripheral, Thrombosis, Tendonitis, Pain, Chest Pain, Pyrexia
This report suggests a potential Benicar Anlo (olmesartan Medoxomil, Amlodipine Besilate) (tablet) (olmesartan Medoxomil, Amlodipine) nasopharyngitis side effect(s) that can have serious consequences. A female patient from BR (weight:NA) was diagnosed with the following health condition(s): hypertension and used Benicar Anlo (olmesartan Medoxomil, Amlodipine Besilate) (tablet) (olmesartan Medoxomil, Amlodipine) (dosage: 80/10 Mg (1 In 1 D, Per Oral) starting 2013. Soon after starting Benicar Anlo (olmesartan Medoxomil, Amlodipine Besilate) (tablet) (olmesartan Medoxomil, Amlodipine) the patient began experiencing various side effects, including:
  • Nasopharyngitis
  • Oedema
  • Oedema Peripheral
  • Thrombosis
  • Tendonitis
  • Pain
  • Chest Pain
  • Pyrexia
Drugs used concurrently:
  • Tacrolimus (tacrolimus) (tacrolimus)
  • Mycophenolate (mycophenolate Mofetil) (mycophenolate Mofetil)
  • Ferrous Sulphate (ferrous Sulfate) (ferrous Sulfate)
  • Vitamin B1/vitamin B2/vitaminb3/vitamin B6/vitamin B5
The patient was hospitalized. Although Benicar Anlo (olmesartan Medoxomil, Amlodipine Besilate) (tablet) (olmesartan Medoxomil, Amlodipine) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as nasopharyngitis, may still occur.

Blood Pressure Increased, Fear Of Disease, Influenza, Arthralgia, Fatigue, Tremor, Stress, Blood Cortisol Decreased, Weight Decreased
This blood pressure increased problem was reported by a health professional from BR. A 68-year-old female patient (weight: NA) was diagnosed with the following medical condition(s): hypertension.On 201308 a consumer started treatment with Benicar Hct (dosage: NA). The following drugs/medications were being taken at the same time:
  • Rosuvastatin (rosuvastatin)
  • Fenofibrate (fenofibrate)
  • Formoterol Fumarate/budesonide (formoterol Fumarate, Budesonide)
  • Bupropion Hydrochloride
  • Clonazepam (clonazepam)
  • Acetylsalicylic Acid (acetylsalicylic Acid)
  • Anti-inflammatory For Pain Knee
When commencing Benicar Hct, the patient experienced the following unwanted symptoms /side effects:
  • Blood Pressure Increased
  • Fear Of Disease
  • Influenza
  • Arthralgia
  • Fatigue
  • Tremor
  • Stress
  • Blood Cortisol Decreased
  • Weight Decreased
Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as blood pressure increased, may become evident only after a product is in use by the general population.

Fatigue, Nausea, Abdominal Distension, Decreased Appetite, Gastroenteritis Viral, Vomiting, Diarrhoea, Hypotension, Lactose Intolerance
This is a Benicar side effect report of a 78-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: hypertension and was treated with Benicar (dosage: NA) starting Jan 17, 2013. Concurrently used drugs: NA. Soon after that, the consumer experienced the following of symptoms:
  • Fatigue
  • Nausea
  • Abdominal Distension
  • Decreased Appetite
  • Gastroenteritis Viral
  • Vomiting
  • Diarrhoea
  • Hypotension
  • Lactose Intolerance
The patient was hospitalized and became disabled. This opens a possibility that Benicar could cause fatigue and that some female patients may be more susceptible.

Obesity, Blood Glucose Increased, Paraesthesia, Abdominal Pain Upper, Weight Decreased, Aortic Disorder, Pancreatic Neoplasm, Pallor, Pain In Extremity
A patient (weight: NA) from BR with the following symptoms: hypertension,abdominal pain upper started Benicar treatment (dosage: 40 Mg (1 In 1 D), Per Oral) on 201311. Soon after starting Benicar treatment, the consumer experienced several side effects, including:
  • Obesity
  • Blood Glucose Increased
  • Paraesthesia
  • Abdominal Pain Upper
  • Weight Decreased
  • Aortic Disorder
  • Pancreatic Neoplasm
  • Pallor
  • Pain In Extremity
. Concurrently used drugs:
  • Morphine
  • Lanzoprazole
  • Aluminum Hydroxide (aluminum Hydroxide) (aluminum Hydroxide)
  • Medicines For Small Fatty Deposits In Less Than 30% Of The Brai
The patient was hospitalized. This finding indicates that some patients can be more vulnerable to developing Benicar side effects, such as obesity.

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 (dosage: Once Daily), which was started on NS. Concurrently used drugs: NA..When starting to take Benicar the consumer reported symptoms, such as:
  • Diarrhoea
  • Weight Decreased
  • Intestinal Villi Atrophy
These side effects may potentially be related to Benicar.

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 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). The consumer presented with:
  • Skin Ulcer
  • Peripheral Vascular Disorder
  • Toe Amputation
which developed 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.

Osteoarthritis, Knee Operation
This report suggests a potential Benicar Hct Osteoarthritis, Knee Operation 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. Soon after starting Benicar Hct the patient began experiencing various side effects, including:
  • Osteoarthritis
  • Knee Operation
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.

Pruritus, Angioedema, Glucose Tolerance Impaired, Peripheral Vascular Disorder, Nervous System Disorder, Oedema Peripheral, Diverticulitis, Hyperglycaemia
This Pruritus, Angioedema, Glucose Tolerance Impaired, Peripheral Vascular Disorder, Nervous System Disorder, Oedema Peripheral, Diverticulitis, Hyperglycaemia 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 commencing Benicar, the patient experienced the following unwanted symptoms/side effects:
  • Pruritus
  • Angioedema
  • Glucose Tolerance Impaired
  • Peripheral Vascular Disorder
  • Nervous System Disorder
  • Oedema Peripheral
  • Diverticulitis
  • Hyperglycaemia
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 pruritus, may become evident only after a product is in use by the general population.

Pyrexia, Sleep Apnoea Syndrome, Thyroid Neoplasm, Blood Pressure Increased
This is a report of a 71-year-old male patient (weight: NA) from US. The patient developed the following symptoms/conditions: hypertension and was treated with Benicar (dosage: NA) starting NS. Concurrently used drugs:
  • Vitamin D (ergocalciferol)
  • Multivitamin (ascorbic Acid, Pyridoxine Hydrochloride, Thiamine Hydrochloride, Colecalciferol, Retin
Soon after that, the consumer experienced the following side effects:
  • Pyrexia
  • Sleep Apnoea Syndrome
  • Thyroid Neoplasm
  • Blood Pressure Increased
This opens a possibility that Benicar treatment could cause the above reactions, including pyrexia, and some male subjects may be more susceptible.

Gastrointestinal Disorder, Diarrhoea, Inflammatory Bowel Disease
A 70-year-old male patient (weight: NA) from US with the following symptoms/conditions: hypertension started Benicar treatment (dosage: NA) on NS. Soon after starting Benicar treatment, the subject experienced various side effects, including:
  • Gastrointestinal Disorder
  • Diarrhoea
  • Inflammatory Bowel Disease
Concurrently used drugs: NA. This finding indicates that some male patients could be more vulnerable to Benicar.

1 of 56 



Top 10 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

Top 10 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

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.


    Discuss Benicar Side Effects

    Did You Have a Benicar Side Effect?

    Yes, Severe
    Yes, Moderate
    Yes, Minor
    No

    How Effective is Benicar for You?

    Exceeded Expectations
    Effective
    Somewhat Effective
    Not Effective

    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