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Benicar Side Effects

Report Benicar Side Effects

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

Examples: headache, dizziness


The most commonly reported Benicar side effects are:
Muscle Pain (117 reports)
Afternoon Sleepiness (74 reports)
Tired All The Time (59 reports)
Cough (53 reports)
Hair Thinning (47 reports)
Mild Diarrhea (31 reports)
Afternoon Sleepiness, Mild Diarrhea (17 reports)
Gaing Weigh (13 reports)
Tired (12 reports)

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


To view a complete list of submitted side effects, please follow the link Benicar side effects . You can also compare Benicar side effects or view FDA reports.

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).
The 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 identified a causal relationship between the drug and the listed risk.

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Surgery
on Dec 18, 2013 Male from BR , 63 years of age, weighting 149.9 lb, was diagnosed with and was treated with Benicar. Directly after, patient experienced the unwanted or unexpected Benicar side effects: surgery. Benicar dosage: N/A.
Associated medications used: Patient was hospitalized.

Malabsorption, Dehydration, Renal Failure Acute
Patient was taking Benicar. Patient felt the following Benicar side effects: malabsorption, dehydration, renal failure acute on Dec 03, 2013 from US Additional patient health information: Female , 63 years of age, was diagnosed with and. Benicar dosage: 30 Mg (20mg In Am And Half Of 20mg Tablet At Pm),per Oral. Patient was hospitalized.

Erysipelas
Adverse event was reported on Nov 27, 2013 by a Female taking Benicar Anlo (Dosage: N/A) was diagnosed with and. Location: BR , 90 years of age, After Benicar was administered, patient encountered several Benicar side effects: erysipelas. Patient was hospitalized.

Choking, Vomiting, Dyspnoea, Throat Tightness, Nasal Septum Deviation
on Nov 26, 2013 Female from BR , weighting 138.9 lb, was diagnosed with and was treated with Benicar Hct. Directly after, patient experienced the unwanted or unexpected Benicar side effects: choking, vomiting, dyspnoea, throat tightness, nasal septum deviation. Benicar Hct dosage: 20/12.5 Mg ( 1 In 1 D), Per Oral.


Diarrhoea, Urine Output Decreased
on Nov 05, 2013 Female from US , 67 years of age, was diagnosed with and was treated with Benicar. Patient felt the following Benicar side effects: diarrhoea, urine output decreased. Benicar dosage: One Once Daily.

Weight Decreased, Diarrhoea
Patient was taking Benicar. After Benicar was administered, patient encountered several Benicar side effects: weight decreased, diarrhoea on Oct 30, 2013 from US Additional patient health information: Female , 70 years of age, weighting 110.0 lb, was diagnosed with and. Benicar dosage: 40 Mg, 1 Pill, Once Per Day, By Mouth.
Multiple concurrent drugs taken:
  • Synthoid
  • Cloridine
  • Bystolic
  • Folgard
  • Crestor
  • Multivitamin
  • Occuvite
Patient was hospitalized.

Malaise, Fatigue, Headache, Back Pain, Ear Infection, Hiatus Hernia, Post Procedural Complication, Myocardial Oedema, Sinusitis
Adverse event was reported on Feb 19, 2014 by a Female taking Benicar (Dosage: N/A) was diagnosed with and. Location: US , 62 years of age, weighting 145.0 lb, Directly after, patient experienced the unwanted or unexpected Benicar side effects: malaise, fatigue, headache, back pain, ear infection, hiatus hernia, post procedural complication, myocardial oedema, sinusitis.

Hypoaesthesia Oral, Hypersensitivity, Feeling Abnormal, Knee Arthroplasty
on Dec 12, 2013 Female from US , 60 years of age, weighting 137.0 lb, was diagnosed with and was treated with Benicar. Patient felt the following Benicar side effects: hypoaesthesia oral, hypersensitivity, feeling abnormal, knee arthroplasty. Benicar dosage: N/A.
Multiple prescriptions taken: Patient was hospitalized.

Road Traffic Accident, Cervical Vertebral Fracture, Spinal Disorder, Injury
on Oct 23, 2013 Male from US , 75 years of age, weighting 175.0 lb, was diagnosed with and was treated with Benicar. After Benicar was administered, patient encountered several Benicar side effects: road traffic accident, cervical vertebral fracture, spinal disorder, injury. Benicar dosage: N/A. Patient was hospitalized.

Pruritus, Ageusia, Parosmia
Patient was taking Benicar. Directly after, patient experienced the unwanted or unexpected Benicar side effects: pruritus, ageusia, parosmia on Oct 22, 2013 from US Additional patient health information: Female , 77 years of age, weighting 198.0 lb, was diagnosed with and. Benicar dosage: 40mg, 1 Pill A Day, 1 Mouth.
Associated medications used:
  • Amlodipine
  • Besylate 10mg
  • Pravastatin 40 Mg
  • Hydrochlorot 12.5 Mg
  • Carvedilol 6.25mg
  • Aspirin 81 Mg
  • Protetine


Diarrhoea, Malabsorption, Abdominal Distension, Eructation, Blood Thyroid Stimulating Hormone Increased, Hiatus Hernia, Uterine Disorder, Aspartate Aminotransferase Increased
Adverse event was reported on Oct 18, 2013 by a Female taking Benicar (Dosage: N/A) was diagnosed with and. Location: US , 76 years of age, Patient felt the following Benicar side effects: diarrhoea, malabsorption, abdominal distension, eructation, blood thyroid stimulating hormone increased, hiatus hernia, uterine disorder, aspartate aminotransferase increased.
Multiple prescriptions taken:
  • Benicar Hct (40/25 Mg)
  • Levemir (insulin Detemir)
  • Novolog (insulin Aspart)
  • Aromasin(exemestane)
  • Ergocalciferol(ergocalciferol
  • Persantine(dipyridamol)
  • Protonix
  • Synthroid(levothyroxine Sodium)


Cholecystectomy, Hypotension, Syncope
on Oct 16, 2013 Male from BR , 60 years of age, was diagnosed with and was treated with Benicar Anlo. After Benicar was administered, patient encountered several Benicar side effects: cholecystectomy, hypotension, syncope. Benicar Anlo dosage: N/A. Patient was hospitalized.

Arthralgia, Back Pain, Diarrhoea, Therapeutic Response Decreased
on Oct 30, 2013 Female from US , 71 years of age, was treated with Benicar Hct. Directly after, patient experienced the unwanted or unexpected Benicar side effects: arthralgia, back pain, diarrhoea, therapeutic response decreased. Benicar Hct dosage: 40-12.5 Mg, Per Oral.
Associated medications used:
  • Dilaudid
  • Baclofen
  • Vitamin C (Per Oral)
  • Bupivacaine
  • Clonidine
  • Desyrel (Nightly (100 Mg, 1 In 1 D) , Per Oral)
  • Mirapex (1.5 Mg (0.5 Mg, 3 In 1 D) Per Oral)
  • Synthroid , Levothroid (Every Morning Before Breakfast (75 Mcg, 1 In 1 D) Per Oral)


Arthralgia, Back Pain, Diarrhoea, Therapeutic Response Decreased, Bursitis
Patient was taking Benicar Hct. Patient felt the following Benicar side effects: arthralgia, back pain, diarrhoea, therapeutic response decreased, bursitis on Oct 30, 2013 from US Additional patient health information: Female , 71 years of age, . Benicar Hct dosage: 40 Mg/12.5 Mgdaily.
Multiple prescriptions taken:
  • Colestid (1 G, 2x/day)
  • Bupivacaine (2.998 Mg, Daily)
  • Desyrel (100 Mg, Nightly)
  • Dilaudid (5.996 Mg)
  • Dilaudid (8 Mg, As Needed)
  • Baclofen (59.96 Ug, Daily)
  • Vitamin C (1000 Mg, Daily)
  • Clonidine (29.98 Ug, Daily)


Diarrhoea, Nausea, Vomiting, Malnutrition, Electrolyte Imbalance, Gastrointestinal Disorder, Malabsorption
Adverse event was reported on Oct 15, 2013 by a Male taking Benicar Hct (Dosage: N/A) was diagnosed with and. Location: US , 59 years of age, weighting 237.0 lb, After Benicar was administered, patient encountered several Benicar side effects: diarrhoea, nausea, vomiting, malnutrition, electrolyte imbalance, gastrointestinal disorder, malabsorption.
Multiple concurrent drugs taken: Patient was hospitalized.

Pain, Movement Disorder, Groin Pain
on Nov 04, 2013 Female from US , 81 years of age, weighting 142.0 lb, was diagnosed with and was treated with Benicar. Directly after, patient experienced the unwanted or unexpected Benicar side effects: pain, movement disorder, groin pain. Benicar dosage: Pm.
Associated medications used:
  • Benicar Hct
  • Metoprolol (metoprolol)
  • Amlodipine (amlodipine)
  • Clopidogrel (clopidogrel)
Patient was hospitalized.

Diarrhoea, No Therapeutic Response, Hypotension, Hypovolaemia, Syncope, Anaemia, Pancreatitis Acute, Hyponatraemia
on Oct 08, 2013 Female from US , 70 years of age, weighting 112.2 lb, was diagnosed with and was treated with Benicar. Patient felt the following Benicar side effects: diarrhoea, no therapeutic response, hypotension, hypovolaemia, syncope, anaemia, pancreatitis acute, hyponatraemia. Benicar dosage: Benicar Daily. Patient was hospitalized.

Syncope, Arrhythmia
Patient was taking Benicar (olmesartan Medoxomil) (tablet) (olmesartan Medoxomil). After Benicar was administered, patient encountered several Benicar side effects: syncope, arrhythmia on Oct 08, 2013 from BR Additional patient health information: Male , 74 years of age, weighting 147.7 lb, was diagnosed with and. Benicar (olmesartan Medoxomil) (tablet) (olmesartan Medoxomil) dosage: 40 Mg (40 Mg, 1 In 1 D), Per Oral.
Multiple concurrent drugs taken: Patient was hospitalized.

Cataract Operation, Blood Pressure Increased, Yellow Skin, Local Swelling, Erythema, Feeling Hot
Adverse event was reported on Oct 08, 2013 by a Female taking Benicar (Dosage: N/A) was diagnosed with and. Location: US , 78 years of age, weighting 89.99 lb, Directly after, patient experienced the unwanted or unexpected Benicar side effects: cataract operation, blood pressure increased, yellow skin, local swelling, erythema, feeling hot.
Associated medications used:
  • Celebrex (2 Dosage Forms (1 Dosage Forms, Bid))
  • Prednisone
  • Bystolic
  • Cipro (ciprofloxacin) (ciprofloxacin)


Coeliac Disease
on Oct 08, 2013 Female from US , 61 years of age, weighting 190.0 lb, was diagnosed with and was treated with Benicar. Patient felt the following Benicar side effects: coeliac disease. Benicar dosage: 1 Pill, Once Daily, Taken By Mouth.

Diarrhoea, No Therapeutic Response, Hypotension, Hypovolaemia, Syncope, Anaemia, Pancreatitis Acute, Electrolyte Imbalance, Hyponatraemia
on Oct 03, 2013 Female from US , 70 years of age, weighting 112.2 lb, was diagnosed with and was treated with Benicar. After Benicar was administered, patient encountered several Benicar side effects: diarrhoea, no therapeutic response, hypotension, hypovolaemia, syncope, anaemia, pancreatitis acute, electrolyte imbalance, hyponatraemia. Benicar dosage: N/A. Patient was hospitalized.

Colitis, Coeliac Disease, Weight Decreased, Asthenia, Syncope
Patient was taking Benicar. Directly after, patient experienced the unwanted or unexpected Benicar side effects: colitis, coeliac disease, weight decreased, asthenia, syncope on Oct 01, 2013 from US Additional patient health information: Male , 79 years of age, weighting 206.0 lb, was diagnosed with and. Benicar dosage: N/A. Patient was hospitalized and became disabled.

Abdominal Pain Upper, Nausea, Hypertension, Diarrhoea, Fatigue, Back Pain, Swelling, Gastrointestinal Disorder
Adverse event was reported on Oct 01, 2013 by a Female taking Benicar (Dosage: 1 Tablet) was diagnosed with and. Location: US , 57 years of age, weighting 197.0 lb, Patient felt the following Benicar side effects: abdominal pain upper, nausea, hypertension, diarrhoea, fatigue, back pain, swelling, gastrointestinal disorder. Patient was hospitalized.

Stevens-johnson Syndrome, Hypoaesthesia, Blood Pressure Increased, Temperature Intolerance, Pain In Extremity
on Aug 06, 2012 Female from US , 47 years of age, weighting 165.0 lb, was diagnosed with and was treated with Benicar Hct (hydrochlorothiazide, Olmesartan Medoxomil ) (tablet) (hydrochlorothiazide, Olmesartan M. After Benicar was administered, patient encountered several Benicar side effects: stevens-johnson syndrome, hypoaesthesia, blood pressure increased, temperature intolerance, pain in extremity. Benicar Hct (hydrochlorothiazide, Olmesartan Medoxomil ) (tablet) (hydrochlorothiazide, Olmesartan M dosage: 40/25mg, (qd), Per Oral.

Arteriosclerosis, Overdose, Insomnia
on Sep 26, 2013 Female from BR , 64 years of age, weighting 180.8 lb, was diagnosed with and was treated with Benicar Anlo. Directly after, patient experienced the unwanted or unexpected Benicar side effects: arteriosclerosis, overdose, insomnia. Benicar Anlo dosage: N/A.
Associated medications used:
  • Methyldopa
  • Nph Insulin (insulin Injection, Isophane) (insulin Injection, Isophane)
  • Regular Insulin (insulin) (insulin)
  • Metformin (metformin) (metformin)
Patient was hospitalized.

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Record and Track Your Side Effects

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.

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JustAnswer.com

Safety Alerts, Active Ingredients, Usage Information

Alternative BENICAR Names:OLMESARTA

Active Ingredient: HYDROCHLO OLMESARTA

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