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Olmesar Side Effects

Report Olmesar Side Effects

If you experienced any harmful or unwanted effects of Olmesar, please share your experience. This could help to raise awareness about Olmesar side effects, identify uknown risks and inform health professionals and patients taking Olmesar.

Examples: headache, dizziness


The most commonly reported Olmesar side effects are:
Dry Cough (10 reports)
Erectile Disfunction (8 reports)
Low Bp (8 reports)
Severe Palpitations (6 reports)
Dizziness (5 reports)
Fatigue (4 reports)
Dizzyness And Fatigue (3 reports)
Beat Missing (2 reports)
Creatine Level (1 reports)
Dizziness And Fatigue (1 reports)
Hard Breathing (1 reports)
Hedache (1 reports)

If you have experienced a side effect listed above, you can check a box to report it.


View a complete list of Olmesar side effects or compare Olmesar side effects

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 (eg, physician, pharmacist). Your health care provider can provide additional clinical information and complete a copy of the side effect reporting form.

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.

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Olmesar Side Effects Reported to FDA

The following 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.


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.
Hyponatraemia, Dehydration, Hypovolaemia
on May 17, 2013 Female from AU , 64 years of age, weighting 149.9 lb, was treated with Olmesartan Amlodipine. Directly after, patient experienced the unwanted or unexpected Olmesar side effects: hyponatraemia, dehydration, hypovolaemia. Olmesartan Amlodipine dosage: 1 Dose Specified.
Associated medications used:
  • Moduretic (1 Dose Specified)
  • Alprazolam (alprazolam) (alprazolam)
  • Budesonide (budesonide) (budesonide)
  • Fluticasone
  • Paracetamol
  • Salbutamol (salbutamol) (salbutamol)
  • Tiotropium (tiotropium) (tiotropium)
Patient was hospitalized.

Maternal Exposure During Pregnancy, Oligohydramnios
Patient was taking Olmesartan Medoxomil. Patient felt the following Olmesar side effects: maternal exposure during pregnancy, oligohydramnios on Apr 30, 2013 from DE Additional patient health information: Female , 38 years of age, was diagnosed with and. Olmesartan Medoxomil dosage: N/A.

Clonus, Malabsorption
Adverse event was reported on Apr 19, 2013 by a Male taking Olmesartan Medoxomil (Dosage: (20 Mg, 1 In 1 D), Oral) was diagnosed with and. Location: IT , 67 years of age, After Olmesar was administered, patient encountered several Olmesar side effects: clonus, malabsorption.
Multiple concurrent drugs taken:
  • Cardioaspirin (acetylsalicylic Acid) (acetylsalicylic Acid )
  • Pantoprazole (pantoprazole) (pantoprazole)
  • Mesalazine (mesalazine) (mesalazine)
  • Rifaximin (rifaximin) (rifaximin)
Patient was hospitalized.

Cerebrovascular Accident, Nephrolithiasis
on Mar 08, 2013 Female from BR , weighting 180.8 lb, was treated with Olmesartan Medoxomil. Directly after, patient experienced the unwanted or unexpected Olmesar side effects: cerebrovascular accident, nephrolithiasis. Olmesartan Medoxomil dosage: N/A.
Associated medications used:
  • Losartan Potassium W/hctz(hydrochlorothiazide, Losartan Potassium)(hydrochlorothiazide, Losartan Pot
  • Aspirina (acetylsalicylic Acid)(acetylsalicylic Acid)
  • Atenolol (atenolol)(50 Milligram)(atenolol)
  • Hygroton (chlortalidone)(25 Milligram) (chlortalidon8)
  • Tylenol(paracetamol)(paracetamol)



Hypotension
on Feb 11, 2013 Male from IT , 73 years of age, was treated with Olmesartan Medoxomil. Patient felt the following Olmesar side effects: hypotension. Olmesartan Medoxomil dosage: N/A.
Multiple prescriptions taken:
  • Amlodipine
  • Amlodipine
  • Amlodipine
  • Triatec
  • Ivabradine (ivabradine (ivabradine)
Patient was hospitalized.

Syncope, Hypotension
Patient was taking Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide. After Olmesar was administered, patient encountered several Olmesar side effects: syncope, hypotension on Feb 13, 2013 from IT Additional patient health information: Female , 86 years of age, . Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide dosage: N/A.
Multiple concurrent drugs taken:
  • Lasix (furosemide) (furosemide)
  • Seroquel
  • Ebixa (memantine Hydrochloride) (memantine Hydrochloride)
Patient was hospitalized.

Alcoholic Seizure
Adverse event was reported on Mar 07, 2013 by a Male taking Olmesartan Medoxomil + Hctz (Dosage: 40/?? Mg (qd), Per Oral) was diagnosed with and. Location: US , 68 years of age, weighting 190.0 lb, Directly after, patient experienced the unwanted or unexpected Olmesar side effects: alcoholic seizure.
Associated medications used:
  • Lithium Carbonate (lithium Carbonate) (lithium Carbonate)
  • Advair (fluticasone Propionate, Salmeterol Xinafoate) (fluticasone Propionate, Salmeterol Xinafoate)
  • Celebrex (celecoxib) (celecoxib)
Patient was hospitalized.

Syncope
on Feb 07, 2013 Female from IT , 41 years of age, was diagnosed with and was treated with Olmesartan Medoxomil. Patient felt the following Olmesar side effects: syncope. Olmesartan Medoxomil dosage: N/A.

Hyponatraemia, Altered State Of Consciousness, Pneumonia, Coma Scale Abnormal
on Feb 20, 2013 Female from FR , 68 years of age, was diagnosed with and was treated with Olmesartan Medoxomil/hydrochlorothiazide. After Olmesar was administered, patient encountered several Olmesar side effects: hyponatraemia, altered state of consciousness, pneumonia, coma scale abnormal. Olmesartan Medoxomil/hydrochlorothiazide dosage: 40/12.5 Mg (1 In 1 D), Oral.
Multiple concurrent drugs taken:
  • Valdoxan
  • Lasilix
  • Temerit (nebivolol) (nebivolol)
  • Diffu K (potassium Chloride) (potassium Chloride)
  • Ixprim (paracetamol, Tramadol Hydrochloride) (paracetamol, Tramadol Hydrochloride)
Patient was hospitalized.

Leukocytoclastic Vasculitis, Diarrhoea, Blood Creatinine Increased, Cytomegalovirus Test Positive, Epstein-barr Virus Test Positive
Patient was taking Olmesartan Medoxomil. Directly after, patient experienced the unwanted or unexpected Olmesar side effects: leukocytoclastic vasculitis, diarrhoea, blood creatinine increased, cytomegalovirus test positive, epstein-barr virus test positive on Jan 28, 2013 from FR Additional patient health information: Female , 85 years of age, was diagnosed with and. Olmesartan Medoxomil dosage: 20 Mg, 1x/day.
Associated medications used:
  • Tahor (10 Mg, 1x/day)
  • Cyclo 3 (1 Df, 2x/day)
  • Lamaline (2 Df, 3x/day)
  • Lisinopril (20 Mg, 1x/day)
  • Zanidip (10 Mg, 1x/day)
Patient was hospitalized.

Thrombocytopenia, Eosinophilia, Hepatitis Cholestatic, Rash, Pyrexia, Hypersensitivity, Megakaryocytes Increased, Lymphocyte Stimulation Test Positive, Idiopathic Thrombocytopenic Purpura
Adverse event was reported on Feb 08, 2013 by a Male taking Olmesartan Medoxomil (Dosage: Unk Mg, Unk) was diagnosed with and. Location: JP , 51 years of age, Patient felt the following Olmesar side effects: thrombocytopenia, eosinophilia, hepatitis cholestatic, rash, pyrexia, hypersensitivity, megakaryocytes increased, lymphocyte stimulation test positive, idiopathic thrombocytopenic purpura.
Multiple prescriptions taken:
  • Amlodipine Besilate (5 Mg, 1x/day)
  • Amlodipine Besilate (10 Mg, 1x/day)
  • Artist (5 Mg, Daily)
  • Bayaspirin (Unk)
  • Protecadin (Unk)
  • Allopurinol (Unk)
  • Corinael (Unk)
  • Wytensin (4 Mg, 1x/day)
Patient was hospitalized.

Shock, Heart Rate Increased, Mean Arterial Pressure Decreased, Deep Vein Thrombosis, Suicide Attempt
on Jan 23, 2013 Female from TR , 34 years of age, was diagnosed with and was treated with Olmesartan. After Olmesar was administered, patient encountered several Olmesar side effects: shock, heart rate increased, mean arterial pressure decreased, deep vein thrombosis, suicide attempt. Olmesartan dosage: N/A.
Multiple concurrent drugs taken:
  • Amlodipine
Patient was hospitalized.

Coeliac Disease, Nausea, Vomiting, Diarrhoea, Gastrointestinal Disorder
on Jan 23, 2013 Female from US , 74 years of age, weighting 136.4 lb, was diagnosed with and was treated with Olmesartan Medoximil 40mg Daiichi Sankyo. Directly after, patient experienced the unwanted or unexpected Olmesar side effects: coeliac disease, nausea, vomiting, diarrhoea, gastrointestinal disorder. Olmesartan Medoximil 40mg Daiichi Sankyo dosage: N/A. Patient was hospitalized.

Intentional Overdose, Toxicity To Various Agents, Shock
Patient was taking Olmesartan Medoxomil. Patient felt the following Olmesar side effects: intentional overdose, toxicity to various agents, shock on Jan 18, 2013 from TR Additional patient health information: Female , 34 years of age, . Olmesartan Medoxomil dosage: 1400 Mg, Single.
Multiple prescriptions taken:
  • Amlodipine Besilate (200 Mg, Single)
Patient was hospitalized.

Hyperkalaemia, Bradycardia, Atrial Fibrillation, Dilatation Atrial, Aortic Arteriosclerosis, Aortic Valve Incompetence, Tricuspid Valve Incompetence
Adverse event was reported on Dec 04, 2012 by a Female taking Olmesartan Medoxomil (Dosage: N/A) was diagnosed with and. Location: ES , child 8 years of age, After Olmesar was administered, patient encountered several Olmesar side effects: hyperkalaemia, bradycardia, atrial fibrillation, dilatation atrial, aortic arteriosclerosis, aortic valve incompetence, tricuspid valve incompetence.
Multiple concurrent drugs taken:
  • Aldactone
  • Amlodipine Besilate (amlodipine Besilate) (amlodipine Besilate)
  • Lercanidipine Hydrochloride (lercanidipine Hyrochloride)
  • Euthyrox (levothyroxoine Sodium) (levothyroxine Sodium)
  • Novomix (insulin Aspart) (insulin Aspart)
Patient was hospitalized.

Malabsorption, Diarrhoea, Sepsis, Pneumatosis Intestinalis
on Dec 26, 2012 Female from JP , 78 years of age, was diagnosed with and was treated with Olmesartan Medoxomil. Directly after, patient experienced the unwanted or unexpected Olmesar side effects: malabsorption, diarrhoea, sepsis, pneumatosis intestinalis. Olmesartan Medoxomil dosage: 20 Mg, 1x/day.
Associated medications used:
  • Norvasc (5 Mg, 1x/day)
  • Norvasc Od (5 Mg, 1x/day)
  • Rinderon (2 Mg, Unk)


Abortion, Exposure During Pregnancy
on Nov 09, 2012 Female from CH , 38 years of age, was diagnosed with and was treated with Olmesartan. Patient felt the following Olmesar side effects: abortion, exposure during pregnancy. Olmesartan dosage: N/A.

Blood Potassium Increased, Blood Sodium Decreased, Loss Of Consciousness, Renal Failure Acute, Bradyphrenia
Patient was taking Olmesartan Medoxomil. After Olmesar was administered, patient encountered several Olmesar side effects: blood potassium increased, blood sodium decreased, loss of consciousness, renal failure acute, bradyphrenia on Nov 06, 2012 from IT Additional patient health information: Female , 89 years of age, was diagnosed with and. Olmesartan Medoxomil dosage: N/A.
Multiple concurrent drugs taken:
  • Lasix (furosemide) ((25 Mg,2 In 1 D))
  • Lasix (furosemide) ((25 Mg,1 In 1 D))
  • Simvastatina (simvastatin)
  • Aranesp (darbepoetin Alfa)
  • Pantorc (pantoprazole Sodium)
  • Stilnox (zolpidem Tartrate)
  • Cardura (doxazosin Mesilate)
  • Tiklid (ticlopidine Hydrochloride)
Patient was hospitalized.

Rash, Pruritus, Lichen Planus
Adverse event was reported on Oct 16, 2012 by a Female taking Olmesartan Medoxomil, Amlodipine Besilate (Dosage: N/A) was diagnosed with and. Location: IT , 59 years of age, Directly after, patient experienced the unwanted or unexpected Olmesar side effects: rash, pruritus, lichen planus.
Associated medications used:
  • Sedoxil (mexazolam) (mexazolam)
  • Candesartan (candesartan) (candesartan)


Urticaria, Product Substitution Issue
on Oct 15, 2012 Female from GB , 60 years of age, weighting 165.3 lb, was treated with Olmesartan Medoxomil. Patient felt the following Olmesar side effects: urticaria, product substitution issue. Olmesartan Medoxomil dosage: N/A.
Multiple prescriptions taken:
  • Letrozole
  • Aveeno
  • Itraconazole


Back Pain, Treatment Noncompliance, Convulsion, Syncope
on Oct 02, 2012 Male from MX , 62 years of age, was diagnosed with and was treated with Olmesartan Medoxomil. After Olmesar was administered, patient encountered several Olmesar side effects: back pain, treatment noncompliance, convulsion, syncope. Olmesartan Medoxomil dosage: N/A. Patient was hospitalized.

Mycosis Fungoides
Patient was taking Olmesartan. Directly after, patient experienced the unwanted or unexpected Olmesar side effects: mycosis fungoides on Sep 27, 2012 from GB Additional patient health information: Male , 70 years of age, weighting 198.4 lb, . Olmesartan dosage: N/A.
Associated medications used:
  • Aspirin
  • Atenolol
  • Rosuvastatin


Hypotension, Blood Potassium Increased, Blood Urea Increased, Blood Creatinine Increased
Adverse event was reported on Sep 26, 2012 by a Female taking Olmesartan Medoxomil, Amlodipine Besilate (Dosage: 20/5 Mg, Oral) was diagnosed with and. Location: IT , 78 years of age, Patient felt the following Olmesar side effects: hypotension, blood potassium increased, blood urea increased, blood creatinine increased.
Multiple prescriptions taken:
  • Doxazosin Mesylate
  • Tenormin
  • Lasix
  • Aldactone
  • Simvastatin
  • Cardioaspirin (acetylsalicylic Acid) (acetylsalicylic Acid)
  • Fosavance (colecalciferol, Alendronate Sodium) (colecalciferol, Alendronate Sodium)
  • Calcio (calcium Carbonate) (calcium Carbonate)
Patient was hospitalized.

Decreased Appetite, Anuria, Renal Failure Acute, Vomiting
on Sep 12, 2012 Female from ES , 61 years of age, was treated with Olmesartan Medoxomil. After Olmesar was administered, patient encountered several Olmesar side effects: decreased appetite, anuria, renal failure acute, vomiting. Olmesartan Medoxomil dosage: N/A.
Multiple concurrent drugs taken:
  • Janumet
Patient was hospitalized.

Alanine Aminotransferase Increased
on Sep 10, 2013 Male from JP , 40 years of age, weighting 167.6 lb, was diagnosed with and was treated with Olmesartan. Directly after, patient experienced the unwanted or unexpected Olmesar side effects: alanine aminotransferase increased. Olmesartan dosage: 20 Mg, Unk.

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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


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  • 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 Olmesar Side Effects

    Did You Have a Olmesar Side Effect?

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    Yes, Moderate
    Yes, Minor
    No

    How Effective is Olmesar for You?

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

    Alternative OLMESAR Names:BENICAR BENICAR HCT TRIBENZOR

    Active Ingredient: AMLODIPIN HYDROCHLO OLMESARTA

    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