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Olmesar Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 1056 

Dyspnoea, Ventricular Extrasystoles (8410862-9)
on May 31, 2012 Male from JAPAN , weighting 119.0 lb, was treated with Olmesartan Medoxomil. Directly after, patient experienced the unwanted or unexpected Olmesar side effects: dyspnoea, ventricular extrasystoles. Olmesartan Medoxomil dosage: 20 Mg, Qd.
Associated medications used:
  • Tanatril
  • Onbrez (150 Ug, Unk)


Shock, Haemodynamic Instability, Diarrhoea, Arthritis Bacterial, Renal Failure Acute, Hypotension (8403555-5)
Patient was taking Olmesartan Medoxomil. Patient felt the following Olmesar side effects: shock, haemodynamic instability, diarrhoea, arthritis bacterial, renal failure acute, hypotension on May 22, 2012 from FRANCE Additional patient health information: Male , 96 years of age, . Olmesartan Medoxomil dosage: 10 Mg, Daily.
Multiple prescriptions taken:
  • Avodart (Unk)
  • Bisoprolol Fumarate (1.25 Mg, Unk)
  • Tramadol Hcl (Unk)
  • Alfuzosin Hcl (Unk)
  • Oxacillin (Unk)
  • Lovenox (Unk)
  • Gentamicin (Unk)
  • Lasix (20 Mg, Unk)
Patient was hospitalized.

Chest Pain, Respiratory Disorder (8403504-X)
Adverse event was reported on May 28, 2012 by a Female taking Olmesartan Medoxomil And Hydrochlorothizide (Dosage: [olmesartan Medoxomil 20mg] / [hydrochlorothiazide 12.5mg] (one Tablet), 1x/day) was diagnosed with
  • hypertension
and. Location: BRAZIL , 88 years of age, After Olmesar was administered, patient encountered several Olmesar side effects: chest pain, respiratory disorder.
Multiple concurrent drugs taken:
  • Formoterol Fumarate
  • Isosorbide Mononitrate
  • Bufferin (Unk)
  • Norvasc (Unk)
  • Lasix
  • Sustrate (Unk)
Patient was hospitalized.

Bacteraemia, Pneumonia, Cellulitis (8402112-4)
on May 14, 2012 Female from JAPAN , 46 years of age, weighting 174.2 lb, was treated with Olmesartan Medoxomil. Directly after, patient experienced the unwanted or unexpected Olmesar side effects: bacteraemia, pneumonia, cellulitis. Olmesartan Medoxomil dosage: N/A.
Associated medications used:
  • Norvasc
  • Rebetol (600 Mg;qd;po)
  • Loxoprofen
  • Urso 250
  • Marzulene-s
  • Abilify
  • Interferon (3 Miu;qd;iv)
  • Rohypnol
Patient was hospitalized.


Pulmonary Embolism (8398719-3)
on May 24, 2012 Male from GERMANY , weighting 165.3 lb, was treated with Olmesartan Medoxomil. Patient felt the following Olmesar side effects: pulmonary embolism. Olmesartan Medoxomil dosage: 20 Mg, Unk.
Multiple prescriptions taken:
  • Fluvastatin Sodium (40 Mg, Unk)
  • Vismodegib And Vismodegib (150 Mg, Qd)
  • Vismodegib And Vismodegib (150 Mg, Qd)
Patient was hospitalized.

Blood Creatine Phosphokinase Increased, Rhabdomyolysis (8388410-1)
Patient was taking Olmesartan Medoxomil. After Olmesar was administered, patient encountered several Olmesar side effects: blood creatine phosphokinase increased, rhabdomyolysis on May 16, 2012 from GERMANY Additional patient health information: Male , 95 years of age, . Olmesartan Medoxomil dosage: N/A.
Multiple concurrent drugs taken:
  • Memantine Hcl (10 Mg)
  • Memantine Hcl (5 Mg)
Patient was hospitalized.

Renal Impairment (8386303-7)
Adverse event was reported on May 16, 2012 by a Male taking Olmesartan Medoxomil (Dosage: N/A) . Location: JAPAN , 67 years of age, Directly after, patient experienced the unwanted or unexpected Olmesar side effects: renal impairment.
Associated medications used:
  • Rebetol
  • Rebetol
  • Adalat Cc
  • Telavic (telaprevir)
  • Peg-intron
  • Telavic (telaprevir)
  • Rebetol
  • Telavic (telaprevir)


Malaise (8384523-9)
on May 16, 2012 Female from JAPAN , 59 years of age, was treated with Olmesartan Medoxomil. Patient felt the following Olmesar side effects: malaise. Olmesartan Medoxomil dosage: N/A.
Multiple prescriptions taken:
  • Rebetol
  • Telavic (telaprevir)
  • Rebetol
  • Peginterferon Alfa-2b
  • Telavic (telaprevir)
  • Peginterferon Alfa-2b
Patient was hospitalized.

Anaemia, Myelodysplastic Syndrome, Platelet Count Decreased (8370971-X)
on May 09, 2012 Female from JAPAN , 72 years of age, was treated with Olmesartan Medoxomil. After Olmesar was administered, patient encountered several Olmesar side effects: anaemia, myelodysplastic syndrome, platelet count decreased. Olmesartan Medoxomil dosage: N/A.
Multiple concurrent drugs taken:
  • Norvasc
  • Basen
  • Januvia
Patient was hospitalized.

Weight Increased, Pain, Anaemia, Renal Failure Chronic, Scrotal Swelling (8368890-8)
Patient was taking Olmesartan Medoxomil. Directly after, patient experienced the unwanted or unexpected Olmesar side effects: weight increased, pain, anaemia, renal failure chronic, scrotal swelling on May 01, 2012 from JAPAN Additional patient health information: Male , 73 years of age, weighting 145.5 lb, . Olmesartan Medoxomil dosage: N/A.
Associated medications used:
  • Atelec (cilnidipine)
  • Calblock (azelnidipine)
  • Argatroban (10 Mg Milligram(s), Daily Dose, Intracavernous)
  • Lipitor
  • Pletal (100 Mg Milligram(s), Bid, Oral)
  • Furosemide
  • Lansoprazole
  • Zetia
Patient was hospitalized.

Sick Sinus Syndrome, Hyperkalaemia (8368251-1)
Adverse event was reported on May 08, 2012 by a Female taking Olmesartan Medoxomil (Dosage: N/A) . Location: JAPAN , 87 years of age, Patient felt the following Olmesar side effects: sick sinus syndrome, hyperkalaemia.
Multiple prescriptions taken:
  • Cozaar
  • Gasmotin
  • Remodellin
  • Amlodipine Besylate
  • Rabeprazole Sodium
Patient was hospitalized.

Cardiac Disorder (8367544-1)
on May 15, 2012 Male from BRAZIL , 67 years of age, was diagnosed with
  • hypertension
and was treated with Olmesartan Medoxomil And Hydrochlorothizide. After Olmesar was administered, patient encountered several Olmesar side effects: cardiac disorder. Olmesartan Medoxomil And Hydrochlorothizide dosage: [olmesartan Medoxomil 40mg] / [hydrochlorothiazide 12.5mg] (one Tablet), Daily.
Multiple concurrent drugs taken:
  • Norvasc (5 Mg, 1x/day)
  • Isosorbide Mononitrate (Unk)
Patient was hospitalized.

Shock (8366074-0)
on May 09, 2012 Male from JAPAN , weighting 116.8 lb, was treated with Olmesartan Medoxomil. Directly after, patient experienced the unwanted or unexpected Olmesar side effects: shock. Olmesartan Medoxomil dosage: 20 Mg, Qd.
Associated medications used:
  • Plavix (75 Mg, Qd)
  • Cymbalta (30 Mg, Qd)
  • Kalimate (5 G, Qd)
  • Magnesium Oxide (1 G, Tid)
  • Zetia (10 Mg, Qd)
  • Pletal (100 Mg, Bid)
  • Dezolam (0.5 Mg, Tid)
  • Epel (50 Mg, Tid)


Haemoglobin Decreased, Fall, Haematoma (8350946-7)
Patient was taking Olmesartan Medoxomil. Patient felt the following Olmesar side effects: haemoglobin decreased, fall, haematoma on May 02, 2012 from ITALY Additional patient health information: Male , 77 years of age, . Olmesartan Medoxomil dosage: N/A.
Multiple prescriptions taken:
  • Simvastatin
  • Levothyroxine Sodium
  • Metformin Hcl
  • Rabeprazole Sodium
  • Coumadin (Interrupted On 16apr2012)
Patient was hospitalized.

Hyperuricaemia, Pancreatitis, Rash (8349143-0)
Adverse event was reported on Apr 30, 2012 by a Male taking Olmesartan Medoxomil (Dosage: N/A) . Location: JAPAN , 49 years of age, After Olmesar was administered, patient encountered several Olmesar side effects: hyperuricaemia, pancreatitis, rash.
Multiple concurrent drugs taken:
  • Rebetol
  • Peg-intron
  • Telavic (telaprevir)
  • Rebetol
  • Norvasc
  • Rebetol
  • Rebetol
Patient was hospitalized.

Decreased Appetite, Vomiting, Haemoglobin Decreased (8348119-7)
on Apr 24, 2012 Female from JAPAN , 65 years of age, was treated with Olmesartan Medoxomil. Directly after, patient experienced the unwanted or unexpected Olmesar side effects: decreased appetite, vomiting, haemoglobin decreased. Olmesartan Medoxomil dosage: N/A.
Associated medications used:
  • Telavic (telaprevir)
  • Lansoprazole
  • Peginterferon Alfa-2a
  • Lendem
  • Ribavirin
  • Ribavirin
  • Urso 250
Patient was hospitalized.

Myocardial Infarction, Muscular Weakness (8347896-9)
on Apr 27, 2012 Male from CHINA , 86 years of age, was treated with Olmesartan Medoxomil. Patient felt the following Olmesar side effects: myocardial infarction, muscular weakness. Olmesartan Medoxomil dosage: N/A.
Multiple prescriptions taken:
  • Alprostadil
  • Lasoprazole
  • Nebivolol
  • Livalo (2 Mg;qx;po, 4 Mg;1x;po)
  • Livalo (2 Mg;qx;po, 4 Mg;1x;po)
  • Lvgebilei


Albumin Urine Present, Blood Potassium Increased (8344198-1)
Patient was taking Olmesartan Medoxomil. After Olmesar was administered, patient encountered several Olmesar side effects: albumin urine present, blood potassium increased on Apr 27, 2012 from JAPAN Additional patient health information: Female , 78 years of age, . Olmesartan Medoxomil dosage: 10 Mg.
Multiple concurrent drugs taken:
  • Amlodipine (5 Mg)
  • Rezaltas Combination (1 Df)
  • Doxazosin Mesylate (4 Mg)
  • Doxazosin Mesylate (0.5 Mg)
  • Rasilez (150 Mg)
  • Calblock (8 Mg)
  • Bisoprolol Fumarate (2.5 Mg)


Cardiac Failure, Hyperglycaemia, Myocardial Infarction (8338250-4)
Adverse event was reported on Apr 26, 2012 by a Male taking Olmesartan Medoxomil (Dosage: N/A) . Location: JAPAN , 68 years of age, Directly after, patient experienced the unwanted or unexpected Olmesar side effects: cardiac failure, hyperglycaemia, myocardial infarction.
Associated medications used:
  • Amaryl
  • Levemir
  • Januvia
  • Amaryl
Patient was hospitalized.

Neutropenia (8337018-2)
on Apr 24, 2012 Male from SPAIN , 88 years of age, was diagnosed with
  • hypertension
and was treated with Olmesartan Medoxomil. Patient felt the following Olmesar side effects: neutropenia. Olmesartan Medoxomil dosage: 40 Mg (40 Mg, 1 In 1 D), Oral.

Blood Pressure Decreased, Blood Urea Increased (8336964-3)
on Apr 25, 2012 Male from JAPAN , 79 years of age, weighting 153.4 lb, was diagnosed with
  • hypertension
and was treated with Olmesartan Medoxomil. After Olmesar was administered, patient encountered several Olmesar side effects: blood pressure decreased, blood urea increased. Olmesartan Medoxomil dosage: 20 Mg (20 Mg, 1 In 1 D),per Oral, 10 Mg (10 Mg,l In 1 D),per Oral.

Oedema Peripheral, Urinary Tract Infection, Pain In Extremity, Disease Recurrence, Pericarditis (8336963-1)
Patient was taking Olmesartan Medoxomil. Directly after, patient experienced the unwanted or unexpected Olmesar side effects: oedema peripheral, urinary tract infection, pain in extremity, disease recurrence, pericarditis on Apr 23, 2012 from GERMANY Additional patient health information: Female , 65 years of age, was diagnosed with
  • hypertension
and. Olmesartan Medoxomil dosage: ,oral.
Associated medications used:
  • Iodine (iodine) (iodine)
Patient was hospitalized.

Eye Disorder (8330084-X)
Adverse event was reported on Apr 25, 2012 by a Female taking Olmesartan Medoxomil (Dosage: 20 Mg (one Tablet), 1x/day) was diagnosed with
  • hypertension
  • blood cholesterol increased
  • glaucoma
and. Location: BRAZIL , 79 years of age, Patient felt the following Olmesar side effects: eye disorder.
Multiple prescriptions taken:
  • Lipitor (40 Mg (one Tablet), 1x/day)
  • Xalatan (3 Ug (one Drop In Each Eye), 1x/day)


Stent Placement, Cardiovascular Disorder (8317247-4)
on Apr 17, 2012 Female from UNITED STATES , weighting 130.0 lb, was diagnosed with
  • hypertension
and was treated with Olmesartan Medoxomil. After Olmesar was administered, patient encountered several Olmesar side effects: stent placement, cardiovascular disorder. Olmesartan Medoxomil dosage: 20 Mg, Unk.
Multiple concurrent drugs taken:
  • Oxycontin (80 Mg, Bid)


Pulmonary Embolism (8315624-9)
on Apr 12, 2012 Male from GERMANY , weighting 165.3 lb, was treated with Olmesartan Medoxomil. Directly after, patient experienced the unwanted or unexpected Olmesar side effects: pulmonary embolism. Olmesartan Medoxomil dosage: 20 Mg, Unk.
Associated medications used:
  • Fluvastatin Sodium (40 Mg, Unk)
  • Vismodegib And Vismodegib (150 Mg, Qd)
  • Vismodegib And Vismodegib (150 Mg, Qd)
Patient was hospitalized.

Showing 1-25 of 1056 

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It is very important to keep track of all side effects and discuss them with your doctor. If you think you may have a medical emergency, call your doctor or 911 immediately.

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

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 Information

Alternative OLMESAR Names:BENICAR BENICAR HCT TRIBENZOR

Active Ingredient: AMLODIPIN HYDROCHLO OLMESARTA

More About Olmesar

Side Effects reported to FDA: 1056. View Olmesar Adverse Reports

Olmesar safety alerts: 2013 2010

Reported deaths: 64

Reported hospitalizations: 544

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]

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