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Olmesar Side Effects

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.

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.

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.
Weight Decreased, Diarrhoea, Malabsorption, Colitis Microscopic
on Feb 24, 2014 Male from US , 61 years of age, was diagnosed with and was treated with Olmesartan. Directly after, patient experienced the unwanted or unexpected Olmesar side effects: weight decreased, diarrhoea, malabsorption, colitis microscopic. Olmesartan dosage: 20 Mg (20 Mg, Qd), Per Oral.
Associated medications used:
  • Amlodipine (amlodipine) (amlodipine)
  • Budesonide (budesonide) (budesonide)
  • Pravastatin (pravastatin) (pravastatin)
  • Aspirin (acetylsalicylic Acid) (acetylsalicylic Acid)


Angioedema
Patient was taking Olmesartan. Patient felt the following Olmesar side effects: angioedema on Feb 14, 2014 from CN Additional patient health information: Female , 80 years of age, was diagnosed with and. Olmesartan dosage: N/A.
Multiple prescriptions taken:
  • Urapidil
  • Recombinant Tissue Plasminogen Activator
Patient was hospitalized.

Diarrhoea, Hypokalaemia, Renal Failure Acute, Diverticulum, Hepatic Steatosis, Cholelithiasis, Malabsorption, Enteritis, Duodenitis
Adverse event was reported on Feb 05, 2014 by a Female taking Olmesartan (Dosage: For Years.) was diagnosed with and. Location: DE , 73 years of age, weighting 138.9 lb, After Olmesar was administered, patient encountered several Olmesar side effects: diarrhoea, hypokalaemia, renal failure acute, diverticulum, hepatic steatosis, cholelithiasis, malabsorption, enteritis, duodenitis.
Multiple concurrent drugs taken:
  • Valsartan
  • Ramipril
  • Metformin (metformin)
  • Pantoprazol (pantoprazole)
  • Bisoprolol (bisoprolol)
  • Votum Polus (hydrochlorothiazide, Olmesartan Medoxomil)
  • Copifeo (lercanidipine Hydrochloride)
  • Simvastatin (simvastatin)
Patient was hospitalized.

Bradycardia, Tachycardia, Blood Potassium Increased
on Dec 27, 2013 Female from IT , 89 years of age, weighting 125.7 lb, was diagnosed with and was treated with Olmesartan Medoxomil. Directly after, patient experienced the unwanted or unexpected Olmesar side effects: bradycardia, tachycardia, blood potassium increased. Olmesartan Medoxomil dosage: 20 Mg, 1 In 1 D.
Associated medications used:
  • Spironolactone (25 Mg, 1 In 1 D)



Nausea
on Dec 12, 2013 Male from IT , 72 years of age, was diagnosed with and was treated with Olmesartan. Patient felt the following Olmesar side effects: nausea. Olmesartan dosage: N/A.
Multiple prescriptions taken:
  • Pantoprazole
  • Ranexa
  • Clopidogrel /01220701/
  • Metoprolol /00376901/


Malabsorption, Fatigue, Colitis Microscopic
Patient was taking Olmesartan Medoxomil. After Olmesar was administered, patient encountered several Olmesar side effects: malabsorption, fatigue, colitis microscopic on Dec 06, 2013 from US Additional patient health information: Male , 61 years of age, was diagnosed with and. Olmesartan Medoxomil dosage: N/A.
Multiple concurrent drugs taken:
  • Amlodipine (amlodipine) (amlodipine)
  • Budesonide (budesonide( (budesonide)
  • Pravastatin (pravastatin) (pravastatin)
  • Aspirin (acetylsalicylic Acid) (acetylsalicylic Acid)
Patient was hospitalized.

Diarrhoea, Malabsorption, Renal Failure Acute, Dialysis, Colitis, Hypotension, Coeliac Disease
Adverse event was reported on Dec 05, 2013 by a Male taking Olmesartan Medoxomil (Dosage: N/A) was diagnosed with and. Location: US , 59 years of age, Directly after, patient experienced the unwanted or unexpected Olmesar side effects: diarrhoea, malabsorption, renal failure acute, dialysis, colitis, hypotension, coeliac disease. Patient was hospitalized.

Headache, Face Oedema, Paraesthesia, Dry Mouth
on Oct 25, 2013 Female from IT , 57 years of age, weighting 191.8 lb, was diagnosed with and was treated with Olmesartan Medoxomi. Patient felt the following Olmesar side effects: headache, face oedema, paraesthesia, dry mouth. Olmesartan Medoxomi dosage: 208 Mg,(1 In 1 D), Oral.
Multiple prescriptions taken:
  • Indapamide
  • Lusopress


Somnolence, Disorientation, Fatigue, Dizziness
on Oct 25, 2013 Female from AT , 64 years of age, was treated with Olmesartan Medoxomil. After Olmesar was administered, patient encountered several Olmesar side effects: somnolence, disorientation, fatigue, dizziness. Olmesartan Medoxomil dosage: N/A.
Multiple concurrent drugs taken:
  • Lyrica
  • Amlodipine Besilate
  • Simvastatin
  • Paroxat
  • Saroten
  • Seroquel Xr
  • Praxiten Pliva (oxazepam) (oxazepam)
  • Euthyrox
Patient was hospitalized.

Deep Vein Thrombosis, Arthritis, Blood Chloride Decreased, Blood Cholesterol Increased, Bronchitis, Cholelithiasis, Glaucoma, Neuropathy Peripheral
Patient was taking Olmesartan. Directly after, patient experienced the unwanted or unexpected Olmesar side effects: deep vein thrombosis, arthritis, blood chloride decreased, blood cholesterol increased, bronchitis, cholelithiasis, glaucoma, neuropathy peripheral on Nov 29, 2013 from US Additional patient health information: Female , 36 years of age, weighting 160.1 lb, was diagnosed with and. Olmesartan dosage: N/A.
Associated medications used:
  • Mescolor
  • Chlorphenamine Maleate
  • Endal Hd
  • Zydone
  • Lortab
  • Lorcet-hd
  • Percocet
  • Carbidopa W/levodopa
Patient was hospitalized and became disabled.

Premature Rupture Of Membranes, Oligohydramnios, Premature Delivery, Maternal Exposure During Pregnancy
Adverse event was reported on Oct 23, 2013 by a Female taking Olmesartan (Dosage: 5 Mg, Unk) was diagnosed with and. Location: DE , 38 years of age, Patient felt the following Olmesar side effects: premature rupture of membranes, oligohydramnios, premature delivery, maternal exposure during pregnancy.
Multiple prescriptions taken:
  • Methyldopa
  • Furosemide


Diarrhoea, Weight Decreased, Renal Failure
on Oct 29, 2013 Female from FR , 70 years of age, weighting 189.6 lb, was diagnosed with and was treated with Olmesartan. After Olmesar was administered, patient encountered several Olmesar side effects: diarrhoea, weight decreased, renal failure. Olmesartan dosage: N/A. Patient was hospitalized.

Paralysis
on Oct 07, 2013 Female from IN , 55 years of age, was diagnosed with and was treated with Olmesartan Medoxomil. Directly after, patient experienced the unwanted or unexpected Olmesar side effects: paralysis. Olmesartan Medoxomil dosage: N/A.
Associated medications used:
  • Carzec (3.125mg Per Day)
Patient was hospitalized.

Pancreatitis Acute, Toxicity To Various Agents
Patient was taking Olmesartan Medoxomil, Amlodipine Besilate. Patient felt the following Olmesar side effects: pancreatitis acute, toxicity to various agents on Oct 18, 2013 from DE Additional patient health information: Female , 80 years of age, was diagnosed with and. Olmesartan Medoxomil, Amlodipine Besilate dosage: N/A.
Multiple prescriptions taken:
  • Aspirin (acetylsalicylic Acid)(100 Milligram)(acetylsalicylic Acid)
  • Hydrochlorothiazide (hydrochlorothiazide)(25 Milligram)(hydrochlorothiazide)
Patient was hospitalized.

Bradycardia, Syncope
Adverse event was reported on Sep 17, 2013 by a Male taking Olmesartan Medoxomil/hydrochlorothiazide (Dosage: N/A) was diagnosed with and. Location: IT , 78 years of age, After Olmesar was administered, patient encountered several Olmesar side effects: bradycardia, syncope.
Multiple concurrent drugs taken:
  • Congescor
  • Lanoxin
  • Lasix (furosemide)
Patient was hospitalized.

Hyponatraemia
on Sep 13, 2013 Male from GB , 79 years of age, was diagnosed with and was treated with Olmesartan Medoxomil. Directly after, patient experienced the unwanted or unexpected Olmesar side effects: hyponatraemia. Olmesartan Medoxomil dosage: N/A.
Associated medications used:
  • Hydrochlorothiazide
  • Simvastatin (simvastatin) (simvastatin)
  • Sotalol (sotalol) (-sotalol)
Patient was hospitalized.

Eye Irritation, Actinomycotic Pulmonary Infection
on Sep 10, 2013 Female from BE , 58 years of age, weighting 154.3 lb, was diagnosed with and was treated with Olmesartan Medoxomil/hydrochlorothiazide. Patient felt the following Olmesar side effects: eye irritation, actinomycotic pulmonary infection. Olmesartan Medoxomil/hydrochlorothiazide dosage: N/A.

Pseudolymphoma
Patient was taking Olmesartan Medoxomil. After Olmesar was administered, patient encountered several Olmesar side effects: pseudolymphoma on Feb 18, 2014 from IT Additional patient health information: Male , 51 years of age, was diagnosed with and. Olmesartan Medoxomil dosage: N/A.
Multiple concurrent drugs taken:
  • Nebilet
  • Protium (pantoprazole Sodium) (pantoprazole Sodium)


Eyelid Operation, Blood Pressure Increased, Procedural Complication
Adverse event was reported on Aug 23, 2013 by a Female taking Olmesartan Medoxomil (Dosage: N/A) was diagnosed with and. Location: BR , weighting 160.9 lb, Directly after, patient experienced the unwanted or unexpected Olmesar side effects: eyelid operation, blood pressure increased, procedural complication.
Associated medications used:
  • Norvasc
  • Diamicron Mr (gliclazide) (5 Milligram) (gliclazide)
  • Pantoprazole (pantoprazole) (pantoprazole)
Patient was hospitalized.

Hyponatraemia, Syncope
on Oct 02, 2013 Male from IT , 84 years of age, was treated with Olmesartan Medoxomil (olmesartan Medoxomil) (tablet) (olmesartan Medoxomil). Patient felt the following Olmesar side effects: hyponatraemia, syncope. Olmesartan Medoxomil (olmesartan Medoxomil) (tablet) (olmesartan Medoxomil) dosage: (1 Dosage Forms, 1 In 1 D).
Multiple prescriptions taken:
  • Amlodipine Besilate (amlodipine Besilate) (tablet) (amlodipine Besilate) ((1 Dosage Forms, 1 In 1 D))
  • Riopan
  • Ascriptin
  • Pantoprazole
  • Indomethacin


Diarrhoea, Blood Albumin Decreased, Dehydration, Weight Decreased, Cachexia
on Aug 07, 2013 Male from US , 62 years of age, weighting 147.3 lb, was treated with Olmesartan. After Olmesar was administered, patient encountered several Olmesar side effects: diarrhoea, blood albumin decreased, dehydration, weight decreased, cachexia. Olmesartan dosage: N/A. Patient was hospitalized.

Diarrhoea, Abdominal Distension, Orthostatic Hypotension, Azotaemia, Dehydration
Patient was taking Olmesartan (olmesartan) (tablet) (olmesartan). Directly after, patient experienced the unwanted or unexpected Olmesar side effects: diarrhoea, abdominal distension, orthostatic hypotension, azotaemia, dehydration on Apr 24, 2013 from US Additional patient health information: Male , 64 years of age, was diagnosed with and. Olmesartan (olmesartan) (tablet) (olmesartan) dosage: N/A. Patient was hospitalized.

Diarrhoea, Nausea, Vomiting, Abdominal Tenderness, Oedema Peripheral, Protein Total Decreased, Blood Albumin Decreased, Hypophagia, Malabsorption
Adverse event was reported on Aug 29, 2013 by a Female taking Olmesartan Medoxomil (Dosage: N/A) was diagnosed with and. Location: US , 57 years of age, Patient felt the following Olmesar side effects: diarrhoea, nausea, vomiting, abdominal tenderness, oedema peripheral, protein total decreased, blood albumin decreased, hypophagia, malabsorption.
Multiple prescriptions taken:
  • Amlodipine (amlodipine) (amlodipine)
  • Bisoprolol (bisoprolol) (bisoprolol)
  • Hydrochlorothiazide (hydrochlorothiazide) (hydrochlorothiazide)
  • Omeprazole (omeprazole) (omeprazole)
Patient was hospitalized.

Sinus Headache
on Jul 05, 2013 Male from GB , 79 years of age, was diagnosed with and was treated with Olmesartan. After Olmesar was administered, patient encountered several Olmesar side effects: sinus headache. Olmesartan dosage: N/A.
Multiple concurrent drugs taken:
  • Amoxicillin
  • Ramipril
  • Timoptol-la (timolol Maleate) (timolol Maleate)


Malabsorption, Haemoglobin Decreased, Blood Potassium Decreased, Blood Calcium Decreased, Blood Magnesium Decreased, Hypoalbuminaemia, Vitamin D Deficiency, Intestinal Villi Atrophy, Gastrointestinal Inflammation
on Jun 18, 2013 Male from IT , 75 years of age, was treated with Olmesartan (olmesartan) (tablet) (olmesartan). Directly after, patient experienced the unwanted or unexpected Olmesar side effects: malabsorption, haemoglobin decreased, blood potassium decreased, blood calcium decreased, blood magnesium decreased, hypoalbuminaemia, vitamin d deficiency, intestinal villi atrophy, gastrointestinal inflammation. Olmesartan (olmesartan) (tablet) (olmesartan) dosage: 40 Mg (40 Mg, 1 In 1 D), Oral. Patient was hospitalized.

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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
    Not Effective

    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