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Olmesar Side Effects

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Common Olmesar Side Effects


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

Hypotension (67)
Renal Failure Acute (64)
Dehydration (60)
Dizziness (56)
Hyperkalaemia (55)
Diarrhoea (52)
Fall (48)
Blood Pressure Decreased (46)
Malaise (44)
Syncope (44)
Hypoglycaemia (43)
Condition Aggravated (35)
Renal Impairment (35)
Blood Pressure Increased (34)
Dyspnoea (33)
Weight Decreased (30)
Liver Disorder (29)
Platelet Count Decreased (28)
Bradycardia (27)
Headache (26)

➢ 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.

Olmesar Side Effects Reported to FDA



Olmesar Side Effect Report#9914278
Weight Decreased, Diarrhoea, Malabsorption, Colitis Microscopic
This is a report of a 61-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: hypertension, who was treated with Olmesartan (dosage: 20 Mg (20 Mg, Qd), Per Oral, start time: 2008), combined with:
  • Amlodipine (amlodipine) (amlodipine)
  • Budesonide (budesonide) (budesonide)
  • Pravastatin (pravastatin) (pravastatin)
  • Aspirin (acetylsalicylic Acid) (acetylsalicylic Acid)
and developed a serious reaction and side effect(s): Weight Decreased, Diarrhoea, Malabsorption, Colitis Microscopic after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Olmesartan treatment in male patients, resulting in Weight Decreased side effect.
Olmesar Side Effect Report#9913195
Angioedema
This report suggests a potential Olmesartan Angioedema side effect(s) that can have serious consequences. A 80-year-old female patient (weight: NA) from CN was diagnosed with the following symptoms/conditions: hypertension and used Olmesartan (dosage: NA) starting NS. After starting Olmesartan the patient began experiencing various side effects, including: AngioedemaAdditional drugs used concurrently:
  • Urapidil
  • Recombinant Tissue Plasminogen Activator
The patient was hospitalized. Although Olmesartan demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Angioedema, may still occur.
Olmesar Side Effect Report#9880481
Diarrhoea, Hypokalaemia, Renal Failure Acute, Diverticulum, Hepatic Steatosis, Cholelithiasis, Malabsorption, Enteritis, Duodenitis
This Diarrhoea problem was reported by a health professional from DE. A 73-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: hypertension. On
Sep 06, 2013 this consumer started treatment with Olmesartan (dosage: For Years.). The following drugs were being taken at the same time:
  • Valsartan
  • Ramipril
  • Metformin (metformin)
  • Pantoprazol (pantoprazole)
  • Bisoprolol (bisoprolol)
  • Votum Polus (hydrochlorothiazide, Olmesartan Medoxomil)
  • Copifeo (lercanidipine Hydrochloride)
  • Simvastatin (simvastatin)
When using Olmesartan, the patient experienced the following unwanted symptoms/side effects: Diarrhoea, Hypokalaemia, Renal Failure Acute, Diverticulum, Hepatic Steatosis, Cholelithiasis, Malabsorption, Enteritis, DuodenitisThe 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 Diarrhoea, may become evident only after a product is in use by the general population.
Olmesar Side Effect Report#9789757
Bradycardia, Tachycardia, Blood Potassium Increased
This Bradycardia side effect was reported by a consumer or non-health professional from IT. A 89-year-old female patient (weight:NA) experienced the following symptoms/conditions: hypertension.The patient was prescribed Olmesartan Medoxomil (drug dosage: 20 Mg, 1 In 1 D), which was initiated on
Jan 01, 2013. Concurrently used drugs:
  • Spironolactone (25 Mg, 1 In 1 D)
.After starting to take Olmesartan Medoxomil the consumer reported adverse symptoms, such as: Bradycardia, Tachycardia, Blood Potassium IncreasedThese side effects may potentially be related to Olmesartan Medoxomil.
Olmesar Side Effect Report#9750156
Nausea
This is a report of a 72-year-old male patient (weight: NA) from IT, suffering from the following health symptoms/conditions: hypertension,prophylaxis against gastrointestinal ulcer,coronary artery disease, who was treated with Olmesartan (dosage: NA, start time: 2009), combined with:
  • Pantoprazole
  • Ranexa
  • Clopidogrel /01220701/
  • Metoprolol /00376901/
and developed a serious reaction and side effect(s): Nausea after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Olmesartan treatment in male patients, resulting in Nausea side effect.
Olmesar Side Effect Report#9748068
Malabsorption, Fatigue, Colitis Microscopic
This report suggests a potential Olmesartan Medoxomil Malabsorption side effect(s) that can have serious consequences. A 61-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: hypertension and used Olmesartan Medoxomil (dosage: NA) starting 2008. After starting Olmesartan Medoxomil the patient began experiencing various side effects, including: Malabsorption, Fatigue, Colitis MicroscopicAdditional drugs used concurrently:
  • Amlodipine (amlodipine) (amlodipine)
  • Budesonide (budesonide( (budesonide)
  • Pravastatin (pravastatin) (pravastatin)
  • Aspirin (acetylsalicylic Acid) (acetylsalicylic Acid)
The patient was hospitalized. Although Olmesartan Medoxomil demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Malabsorption, may still occur.
Olmesar Side Effect Report#9746545
Diarrhoea, Malabsorption, Renal Failure Acute, Dialysis, Colitis, Hypotension, Coeliac Disease
This Diarrhoea problem was reported by a physician from US. A 59-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: hypertension. On NS this consumer started treatment with Olmesartan Medoxomil (dosage: NA). The following drugs were being taken at the same time: NA. When using Olmesartan Medoxomil, the patient experienced the following unwanted symptoms/side effects: Diarrhoea, Malabsorption, Renal Failure Acute, Dialysis, Colitis, Hypotension, Coeliac DiseaseThe 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 Diarrhoea, may become evident only after a product is in use by the general population.
Olmesar Side Effect Report#9652094
Headache, Face Oedema, Paraesthesia, Dry Mouth
This Headache side effect was reported by a consumer or non-health professional from IT. A 57-year-old female patient (weight:NA) experienced the following symptoms/conditions: hypertension.The patient was prescribed Olmesartan Medoxomi (drug dosage: 208 Mg,(1 In 1 D), Oral), which was initiated on
Oct 03, 2013. Concurrently used drugs:
  • Indapamide
  • Lusopress
.After starting to take Olmesartan Medoxomi the consumer reported adverse symptoms, such as: Headache, Face Oedema, Paraesthesia, Dry MouthThese side effects may potentially be related to Olmesartan Medoxomi.
Olmesar Side Effect Report#9652023
Somnolence, Disorientation, Fatigue, Dizziness
This is a report of a 64-year-old female patient (weight: NA) from AT, suffering from the following health symptoms/conditions: NA, who was treated with Olmesartan Medoxomil (dosage: NA, start time: 2013), combined with:
  • Lyrica
  • Amlodipine Besilate
  • Simvastatin
  • Paroxat
  • Saroten
  • Seroquel Xr
  • Praxiten Pliva (oxazepam) (oxazepam)
  • Euthyrox
and developed a serious reaction and side effect(s): Somnolence, Disorientation, Fatigue, Dizziness after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Olmesartan Medoxomil treatment in female patients, resulting in Somnolence side effect. The patient was hospitalized.
Olmesar Side Effect Report#9646074
Deep Vein Thrombosis, Arthritis, Blood Chloride Decreased, Blood Cholesterol Increased, Bronchitis, Cholelithiasis, Glaucoma, Neuropathy Peripheral
This report suggests a potential Olmesartan Deep Vein Thrombosis side effect(s) that can have serious consequences. A 36-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: hypertension and used Olmesartan (dosage: NA) starting NS. After starting Olmesartan the patient began experiencing various side effects, including: Deep Vein Thrombosis, Arthritis, Blood Chloride Decreased, Blood Cholesterol Increased, Bronchitis, Cholelithiasis, Glaucoma, Neuropathy PeripheralAdditional drugs used concurrently:
  • Mescolor
  • Chlorphenamine Maleate
  • Endal Hd
  • Zydone
  • Lortab
  • Lorcet-hd
  • Percocet
  • Carbidopa W/levodopa
The patient was hospitalized and became disabled. Although Olmesartan demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Deep Vein Thrombosis, may still occur.
Olmesar Side Effect Report#9642061
Premature Rupture Of Membranes, Oligohydramnios, Premature Delivery, Maternal Exposure During Pregnancy
This Premature Rupture Of Membranes problem was reported by a health professional from DE. A 38-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: cerebrovascular accident. On NS this consumer started treatment with Olmesartan (dosage: 5 Mg, Unk). The following drugs were being taken at the same time:
  • Methyldopa
  • Furosemide
When using Olmesartan, the patient experienced the following unwanted symptoms/side effects: Premature Rupture Of Membranes, Oligohydramnios, Premature Delivery, Maternal Exposure During PregnancyAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Premature Rupture Of Membranes, may become evident only after a product is in use by the general population.
Olmesar Side Effect Report#9632214
Diarrhoea, Weight Decreased, Renal Failure
This Diarrhoea side effect was reported by a physician from FR. A 70-year-old female patient (weight:NA) experienced the following symptoms/conditions: hypertension.The patient was prescribed Olmesartan (drug dosage: NA), which was initiated on
May 30, 2011. Concurrently used drugs: NA..After starting to take Olmesartan the consumer reported adverse symptoms, such as: Diarrhoea, Weight Decreased, Renal FailureThese side effects may potentially be related to Olmesartan. The patient was hospitalized.
Olmesar Side Effect Report#9587221
Paralysis
This is a report of a 55-year-old female patient (weight: NA) from IN, suffering from the following health symptoms/conditions: hypertension, who was treated with Olmesartan Medoxomil (dosage: NA, start time: NS), combined with:
  • Carzec (3.125mg Per Day)
and developed a serious reaction and side effect(s): Paralysis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Olmesartan Medoxomil treatment in female patients, resulting in Paralysis side effect. The patient was hospitalized.
Olmesar Side Effect Report#9585788
Pancreatitis Acute, Toxicity To Various Agents
This report suggests a potential Olmesartan Medoxomil, Amlodipine Besilate Pancreatitis Acute side effect(s) that can have serious consequences. A 80-year-old female patient (weight: NA) from DE was diagnosed with the following symptoms/conditions: hypertension and used Olmesartan Medoxomil, Amlodipine Besilate (dosage: NA) starting 2007. After starting Olmesartan Medoxomil, Amlodipine Besilate the patient began experiencing various side effects, including: Pancreatitis Acute, Toxicity To Various AgentsAdditional drugs used concurrently:
  • Aspirin (acetylsalicylic Acid)(100 Milligram)(acetylsalicylic Acid)
  • Hydrochlorothiazide (hydrochlorothiazide)(25 Milligram)(hydrochlorothiazide)
The patient was hospitalized. Although Olmesartan Medoxomil, Amlodipine Besilate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pancreatitis Acute, may still occur.
Olmesar Side Effect Report#9540271
Bradycardia, Syncope
This Bradycardia problem was reported by a consumer or non-health professional from IT. A 78-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: essential hypertension,cardiac failure chronic. On NS this consumer started treatment with Olmesartan Medoxomil/hydrochlorothiazide (dosage: NA). The following drugs were being taken at the same time:
  • Congescor
  • Lanoxin
  • Lasix (furosemide)
When using Olmesartan Medoxomil/hydrochlorothiazide, the patient experienced the following unwanted symptoms/side effects: Bradycardia, SyncopeThe 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 Bradycardia, may become evident only after a product is in use by the general population.
Olmesar Side Effect Report#9528133
Hyponatraemia
This Hyponatraemia side effect was reported by a consumer or non-health professional from GB. A 79-year-old male patient (weight:NA) experienced the following symptoms/conditions: hypertension.The patient was prescribed Olmesartan Medoxomil (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Hydrochlorothiazide
  • Simvastatin (simvastatin) (simvastatin)
  • Sotalol (sotalol) (-sotalol)
.After starting to take Olmesartan Medoxomil the consumer reported adverse symptoms, such as: HyponatraemiaThese side effects may potentially be related to Olmesartan Medoxomil. The patient was hospitalized.
Olmesar Side Effect Report#9519090
Eye Irritation, Actinomycotic Pulmonary Infection
This is a report of a 58-year-old female patient (weight: NA) from BE, suffering from the following health symptoms/conditions: hypertension, who was treated with Olmesartan Medoxomil/hydrochlorothiazide (dosage: NA, start time: 2010), combined with: NA. and developed a serious reaction and side effect(s): Eye Irritation, Actinomycotic Pulmonary Infection after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Olmesartan Medoxomil/hydrochlorothiazide treatment in female patients, resulting in Eye Irritation side effect.
Olmesar Side Effect Report#9491986
Pseudolymphoma
This report suggests a potential Olmesartan Medoxomil Pseudolymphoma side effect(s) that can have serious consequences. A 51-year-old male patient (weight: NA) from IT was diagnosed with the following symptoms/conditions: hypertension and used Olmesartan Medoxomil (dosage: NA) starting 201210. After starting Olmesartan Medoxomil the patient began experiencing various side effects, including: PseudolymphomaAdditional drugs used concurrently:
  • Nebilet
  • Protium (pantoprazole Sodium) (pantoprazole Sodium)
Although Olmesartan Medoxomil demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pseudolymphoma, may still occur.
Olmesar Side Effect Report#9487089
Eyelid Operation, Blood Pressure Increased, Procedural Complication
This Eyelid Operation 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 201104 this consumer started treatment with Olmesartan Medoxomil (dosage: NA). The following drugs were being taken at the same time:
  • Norvasc
  • Diamicron Mr (gliclazide) (5 Milligram) (gliclazide)
  • Pantoprazole (pantoprazole) (pantoprazole)
When using Olmesartan Medoxomil, the patient experienced the following unwanted symptoms/side effects: Eyelid Operation, Blood Pressure Increased, Procedural ComplicationThe 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 Eyelid Operation, may become evident only after a product is in use by the general population.
Olmesar Side Effect Report#9470471
Hyponatraemia, Syncope
This Hyponatraemia side effect was reported by a health professional from IT. A 84-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Olmesartan Medoxomil (olmesartan Medoxomil) (tablet) (olmesartan Medoxomil) (drug dosage: (1 Dosage Forms, 1 In 1 D)), which was initiated on
Jul 01, 2012. Concurrently used drugs:
  • Amlodipine Besilate (amlodipine Besilate) (tablet) (amlodipine Besilate) ((1 Dosage Forms, 1 In 1 D))
  • Riopan
  • Ascriptin
  • Pantoprazole
  • Indomethacin
.After starting to take Olmesartan Medoxomil (olmesartan Medoxomil) (tablet) (olmesartan Medoxomil) the consumer reported adverse symptoms, such as: Hyponatraemia, SyncopeThese side effects may potentially be related to Olmesartan Medoxomil (olmesartan Medoxomil) (tablet) (olmesartan Medoxomil).
Olmesar Side Effect Report#9448063
Diarrhoea, Blood Albumin Decreased, Dehydration, Weight Decreased, Cachexia
This is a report of a 62-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Olmesartan (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Diarrhoea, Blood Albumin Decreased, Dehydration, Weight Decreased, Cachexia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Olmesartan treatment in male patients, resulting in Diarrhoea side effect. The patient was hospitalized.
Olmesar Side Effect Report#9410698
Diarrhoea, Abdominal Distension, Orthostatic Hypotension, Azotaemia, Dehydration
This report suggests a potential Olmesartan (olmesartan) (tablet) (olmesartan) Diarrhoea side effect(s) that can have serious consequences. A 64-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: hypertension and used Olmesartan (olmesartan) (tablet) (olmesartan) (dosage: NA) starting NS. After starting Olmesartan (olmesartan) (tablet) (olmesartan) the patient began experiencing various side effects, including: Diarrhoea, Abdominal Distension, Orthostatic Hypotension, Azotaemia, DehydrationAdditional drugs used concurrently: NA.The patient was hospitalized. Although Olmesartan (olmesartan) (tablet) (olmesartan) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Diarrhoea, may still occur.
Olmesar Side Effect Report#9404393
Diarrhoea, Nausea, Vomiting, Abdominal Tenderness, Oedema Peripheral, Protein Total Decreased, Blood Albumin Decreased, Hypophagia, Malabsorption
This Diarrhoea problem was reported by a physician from US. A 57-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: hypertension. On NS this consumer started treatment with Olmesartan Medoxomil (dosage: NA). The following drugs were being taken at the same time:
  • Amlodipine (amlodipine) (amlodipine)
  • Bisoprolol (bisoprolol) (bisoprolol)
  • Hydrochlorothiazide (hydrochlorothiazide) (hydrochlorothiazide)
  • Omeprazole (omeprazole) (omeprazole)
When using Olmesartan Medoxomil, the patient experienced the following unwanted symptoms/side effects: Diarrhoea, Nausea, Vomiting, Abdominal Tenderness, Oedema Peripheral, Protein Total Decreased, Blood Albumin Decreased, Hypophagia, MalabsorptionThe 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 Diarrhoea, may become evident only after a product is in use by the general population.
Olmesar Side Effect Report#9393704
Sinus Headache
This Sinus Headache side effect was reported by a health professional from GB. A 79-year-old male patient (weight:NA) experienced the following symptoms/conditions: hypertension.The patient was prescribed Olmesartan (drug dosage: NA), which was initiated on
May 13, 2013. Concurrently used drugs:
  • Amoxicillin
  • Ramipril
  • Timoptol-la (timolol Maleate) (timolol Maleate)
.After starting to take Olmesartan the consumer reported adverse symptoms, such as: Sinus HeadacheThese side effects may potentially be related to Olmesartan.
Olmesar Side Effect Report#9363877
Malabsorption, Haemoglobin Decreased, Blood Potassium Decreased, Blood Calcium Decreased, Blood Magnesium Decreased, Hypoalbuminaemia, Vitamin D Deficiency, Intestinal Villi Atrophy, Gastrointestinal Inflammation
This is a report of a 75-year-old male patient (weight: NA) from IT, suffering from the following health symptoms/conditions: NA, who was treated with Olmesartan (olmesartan) (tablet) (olmesartan) (dosage: 40 Mg (40 Mg, 1 In 1 D), Oral, start time: 2009), combined with: NA. and developed a serious reaction and side effect(s): Malabsorption, Haemoglobin Decreased, Blood Potassium Decreased, Blood Calcium Decreased, Blood Magnesium Decreased, Hypoalbuminaemia, Vitamin D Deficiency, Intestinal Villi Atrophy, Gastrointestinal Inflammation after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Olmesartan (olmesartan) (tablet) (olmesartan) treatment in male patients, resulting in Malabsorption side effect. The patient was hospitalized.


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The appearance of Olmesar 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 Olmesar Side Effects for Women?

Women Side EffectsReports
Dizziness 38
Dehydration 32
Fall 30
Hyperkalaemia 29
Renal Failure Acute 29
Hypotension 28
Malaise 27
Blood Pressure Increased 23
Diarrhoea 23
Syncope 20

What are common Olmesar Side Effects for Men?

Men Side EffectsReports
Hypotension 39
Renal Failure Acute 35
Blood Pressure Decreased 29
Diarrhoea 29
Dehydration 28
Renal Impairment 28
Hyperkalaemia 26
Hypoglycaemia 25
Syncope 24
Condition Aggravated 22

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.

    Olmesar 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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    Discuss Olmesar Side Effects

    Did You Have a Olmesar Side Effect?

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    Yes, Moderate
    Yes, Minor
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    How Effective is Olmesar for You?

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

    More About Olmesar

    Side Effects reported to FDA: 1140

    Olmesar safety alerts: 2014 2013 2010

    Reported deaths: 73

    Reported hospitalizations: 613

    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 Olmesar clinical trials