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Muscle Pain (117)
Afternoon Sleepiness (74)
Tired All The Time (59)
Cough (53)
Hair Thinning (47)
Mild Diarrhea (31)
Afternoon Sleepiness, Mild Diarrhea (17)
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Benicar Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 1182 

Urine Output Decreased, Pruritus, Joint Swelling, Rash, Oedema Peripheral (8417923-9)
on Jun 01, 2012 Female from UNITED STATES , weighting 128.0 lb, was diagnosed with
  • blood pressure increased
and was treated with Benicar. Directly after, patient experienced the unwanted or unexpected Benicar side effects: urine output decreased, pruritus, joint swelling, rash, oedema peripheral. Benicar dosage: 20mg 1 Tablet Daily.

Vascular Rupture, Body Fat Disorder, Carotid Arteriosclerosis, Abdominal Pain Upper, Venous Injury, Vomiting, Obesity (8416252-7)
Patient was taking Benicar Hct. Patient felt the following Benicar side effects: vascular rupture, body fat disorder, carotid arteriosclerosis, abdominal pain upper, venous injury, vomiting, obesity on May 15, 2012 from BRAZIL Additional patient health information: Female , 79 years of age, was diagnosed with
  • hypertension
and. Benicar Hct dosage: 20/12.5 Mg (1 In 1 D), Per Oral.
Multiple prescriptions taken:
  • Acetylsalicylic Acid Srt
  • Alprazolam
  • Atenolol
  • Simvastatin
  • Glucosamine/chondroitin/methylsulfonylmethane


Knee Arthroplasty, Fall (8415820-6)
Adverse event was reported on May 15, 2012 by a Female taking Benicar (Dosage: 40 Mg, (40 Mg, Qd), Per Oral) was diagnosed with
  • hypertension
and. Location: UNITED STATES , 54 years of age, weighting 170.0 lb, After Benicar was administered, patient encountered several Benicar side effects: knee arthroplasty, fall.
Multiple concurrent drugs taken:
  • Soma
  • Xanax
  • Celexa
  • Lisinopril
Patient was hospitalized.

Glucose Tolerance Impaired (8409095-1)
on May 29, 2012 Female from UNITED STATES , weighting 204.0 lb, was diagnosed with
  • hypertension
and was treated with Benicar. Directly after, patient experienced the unwanted or unexpected Benicar side effects: glucose tolerance impaired. Benicar dosage: 12.5 Mg, Daily.
Associated medications used:
  • Premarin (Unk,daily)
  • Premarin (0.625 Mg, Daily)



Rash (8395506-7)
on May 19, 2011 Female from UNITED STATES , 64 years of age, was treated with Benicar. Patient felt the following Benicar side effects: rash. Benicar dosage: N/A.
Multiple prescriptions taken:
  • Aspirin
  • Ventolin (2puff As Required)
  • Biaxin


Helicobacter Infection, Vomiting, Weight Decreased, Hypotension, Clostridial Infection (8386083-5)
Patient was taking Benicar. After Benicar was administered, patient encountered several Benicar side effects: helicobacter infection, vomiting, weight decreased, hypotension, clostridial infection on May 10, 2012 from UNITED STATES Additional patient health information: Male , 81 years of age, was diagnosed with
  • hypertension
and. Benicar dosage: (40 Mg),per Oral.

Abdominal Discomfort, Off Label Use, Abdominal Pain Upper, Flatulence (8380291-5)
Adverse event was reported on May 10, 2012 by a Female taking Benicar (Dosage: N/A) . Location: UNITED STATES , 90 years of age, weighting 179.9 lb, Directly after, patient experienced the unwanted or unexpected Benicar side effects: abdominal discomfort, off label use, abdominal pain upper, flatulence.
Associated medications used:
  • Nexium
  • Nexium


Diplopia, Erysipelas (8376045-6)
on May 02, 2012 Male from BRAZIL , 48 years of age, was diagnosed with
  • hypertension
and was treated with Benicar. Patient felt the following Benicar side effects: diplopia, erysipelas. Benicar dosage: 40 Mg (40 Mg, 1 In 1 D) Per Oral. Patient was hospitalized.

Blood Creatinine Increased, Loss Of Consciousness, Decreased Appetite, Dry Mouth, Blood Pressure Decreased (8374500-6)
on May 11, 2012 Female from UNITED STATES , weighting 189.2 lb, was diagnosed with
  • hypertension
and was treated with Benicar Hct. After Benicar was administered, patient encountered several Benicar side effects: blood creatinine increased, loss of consciousness, decreased appetite, dry mouth, blood pressure decreased. Benicar Hct dosage: N/A.
Multiple concurrent drugs taken:
  • Doxazosin Mesylate
  • Incivek
  • Ribavirin
  • Synthroid
  • Pegasys
Patient was hospitalized.

Cellulitis (8368371-1)
Patient was taking Benicar. Directly after, patient experienced the unwanted or unexpected Benicar side effects: cellulitis on May 08, 2012 from UNITED STATES Additional patient health information: Female , 68 years of age, . Benicar dosage: 40 Mg, Qd.
Associated medications used:
  • Metoprolol (175 Mg, Qd)
  • Albuterol (90 Ug, Other)
  • Amlodipine Besylate (2.5 Mg, Qd)
  • Lactinex (Unk, Bid)
  • Doxazosin Mesylate
  • Aspirin (325 Mg, Qd)
  • Lovastatin (40 Mg, Qd)
  • Furosemide (80 Mg, Qd)
Patient was hospitalized.

Tobacco User (8366876-0)
Adverse event was reported on May 15, 2012 by a Female taking Benicar (Dosage: Unk) was diagnosed with
  • hypertension
and. Location: UNITED STATES , weighting 265.0 lb, Patient felt the following Benicar side effects: tobacco user.
Multiple prescriptions taken:
  • Chantix (0.5 Mg, 1x/day)


Immune Reconstitution Syndrome, Urticaria, Anxiety, Depression, Progressive Multifocal Leukoencephalopathy, Laryngeal Inflammation (8365638-8)
on May 07, 2012 Female from UNITED STATES , 45 years of age, was diagnosed with
  • hypertension
  • multiple sclerosis
  • hyperlipidaemia
and was treated with Benicar. After Benicar was administered, patient encountered several Benicar side effects: immune reconstitution syndrome, urticaria, anxiety, depression, progressive multifocal leukoencephalopathy, laryngeal inflammation. Benicar dosage: N/A.
Multiple concurrent drugs taken:
  • Tysabri
  • Simvastatin
Patient was hospitalized.

Pulmonary Embolism (8356941-6)
on May 03, 2012 Female from UNITED STATES , 51 years of age, weighting 172.0 lb, was treated with Benicar. Directly after, patient experienced the unwanted or unexpected Benicar side effects: pulmonary embolism. Benicar dosage: N/A.
Associated medications used:
  • Nuvaring (1 Df;vag)
Patient was hospitalized and became disabled.

Wrist Fracture, Spinal Column Stenosis, Osteoporosis, Oesophageal Spasm, Depression, Tibia Fracture, Upper Limb Fracture, Spinal Osteoarthritis, Hypothyroidism (8352313-9)
Patient was taking Benicar Hct. Patient felt the following Benicar side effects: wrist fracture, spinal column stenosis, osteoporosis, oesophageal spasm, depression, tibia fracture, upper limb fracture, spinal osteoarthritis, hypothyroidism on May 07, 2012 from UNITED STATES Additional patient health information: Female , 62 years of age, was diagnosed with
  • hypertension
  • migraine
  • hypothyroidism
and. Benicar Hct dosage: N/A.
Multiple prescriptions taken:
  • Preventative Mazalt
  • Levothyroxine Sodium
  • Maxalt (10 Mg Prn)
  • Fiorinal
  • Bentyl (20 Mg Prn)
  • Actonel
  • Actonel (35 Mg Weekly)
Patient was hospitalized.

Eye Disorder, Nausea, Head Discomfort, Abdominal Discomfort, Vertigo, Dizziness (8350087-9)
Adverse event was reported on May 09, 2012 by a Female taking Benicar (Dosage: ^40/12.5 Mg^ Daily) was diagnosed with
  • hypertension
  • fibromyalgia
and. Location: UNITED STATES , weighting 185.0 lb, After Benicar was administered, patient encountered several Benicar side effects: eye disorder, nausea, head discomfort, abdominal discomfort, vertigo, dizziness.
Multiple concurrent drugs taken:
  • Lyrica (50 Mg, 2x/day)
  • Lyrica (75 Mg, 2x/day)
  • Iron (Unk)
  • Pramipexole Dihydrochloride (0.25 Mg, 5x/day)
  • Allopurinol (100 Mg, 2x/day)
  • Vitamin C (Unk)
  • Citalopram (10 Mg, Daily)


Benign Neoplasm, Blood Pressure Increased (8349364-7)
on Apr 23, 2012 Female from BRAZIL , 76 years of age, was diagnosed with
  • hypertension
and was treated with Benicar Hct. Directly after, patient experienced the unwanted or unexpected Benicar side effects: benign neoplasm, blood pressure increased. Benicar Hct dosage: 40 /12.5 Mg (1 In 1 D), Per Oral.
Associated medications used:
  • Sertraline Hydrochloride
  • Acetylsalicylic Acid/aluminum Glycinate/magnesium Carbonate)
  • Rosuvastatin
  • Atenolol


Arrhythmia (8349109-0)
on Apr 26, 2012 Male from BRAZIL , 73 years of age, was diagnosed with
  • hypertension
and was treated with Benicar Hct. Patient felt the following Benicar side effects: arrhythmia. Benicar Hct dosage: 40/12.5mg (1 In 1 D), Per Oral.
Multiple prescriptions taken:
  • Amiodarone Hcl


Cholecystectomy (8336239-2)
Patient was taking Benicar. After Benicar was administered, patient encountered several Benicar side effects: cholecystectomy on Apr 23, 2012 from UNITED STATES Additional patient health information: Female , 84 years of age, . Benicar dosage: N/A.
Multiple concurrent drugs taken:
  • Benicar Hct


Blood Glucose Increased (8333847-X)
Adverse event was reported on Apr 27, 2012 by a Female taking Benicar (Dosage: Unk) was diagnosed with
  • hypertension
and. Location: UNITED STATES , weighting 158.7 lb, Directly after, patient experienced the unwanted or unexpected Benicar side effects: blood glucose increased.
Associated medications used:
  • Corgard (Unk)
  • Atorvastatin Calcium (10 Mg, Once A Day)


Dizziness (8326573-4)
on Aug 06, 2009 Male from UNITED STATES , weighting 190.2 lb, was diagnosed with
  • hypertension
  • sleep apnoea syndrome
and was treated with Benicar. Patient felt the following Benicar side effects: dizziness. Benicar dosage: N/A.
Multiple prescriptions taken:
  • Nuvigil (150 Milligram;)
  • Diltiazem (300 Milligram;)
  • Lipitor (40 Milligram;)
  • Tricor (245 Milligram;)
  • Nadolol (80 Milligram;)
  • Depakote (1500 Milligram;)


Panic Attack, Anxiety, Paranoia (8319793-6)
on Apr 25, 2012 Male from UNITED STATES , weighting 238.0 lb, was diagnosed with
  • hypertension
  • anxiety
  • gout
  • diabetes mellitus
  • gastrooesophageal reflux disease
  • type 2 diabetes mellitus
and was treated with Benicar. After Benicar was administered, patient encountered several Benicar side effects: panic attack, anxiety, paranoia. Benicar dosage: N/A.
Multiple concurrent drugs taken:
  • Paxil
  • Allopurinol
  • Metformin Hcl
  • Nexium
  • Tradjenta (5 Mg)


Nausea, Decreased Appetite, Vomiting, Abdominal Pain Upper (8319443-9)
Patient was taking Benicar. Directly after, patient experienced the unwanted or unexpected Benicar side effects: nausea, decreased appetite, vomiting, abdominal pain upper on Apr 26, 2012 from UNITED STATES Additional patient health information: Female , 48 years of age, . Benicar dosage: N/A.
Associated medications used:
  • Oxycodone Hcl
  • Trazodone Hcl
  • Cardizem
  • Sertraline Hydrochloride
  • Depakote
  • Enlapril
  • Xanax
  • Hectorol (0.5 Mcg 3x Qw 1.0 Mcg 3x Qw 2.0 Mcg 3x Qw 3.0 Mcg 3x Qw 0.5 Mcg 3x Qw 1.5 Mcg 3x Qw)
Patient was hospitalized.

Dehydration, Nausea, Dizziness, Vomiting (8318427-4)
Adverse event was reported on Oct 05, 2010 by a Male taking Benicar (Dosage: N/A) was diagnosed with
  • hypertension
  • non-small cell lung cancer
  • pain
  • depression
and. Location: UNITED STATES , 59 years of age, weighting 164.2 lb, Patient felt the following Benicar side effects: dehydration, nausea, dizziness, vomiting.
Multiple prescriptions taken:
  • Erlotinib Hydrochloride (150mg Per Day)
  • Morphine
  • Lexapro
  • Votrient (600mg Per Day)
  • Imodium
Patient was hospitalized.

Dizziness, Headache, Labyrinthitis, Dyspnoea, Tinnitus, Oedema Peripheral (8318254-8)
on Apr 11, 2012 Female from BRAZIL , 51 years of age, was diagnosed with
  • hypertension
and was treated with Benicar Hct. After Benicar was administered, patient encountered several Benicar side effects: dizziness, headache, labyrinthitis, dyspnoea, tinnitus, oedema peripheral. Benicar Hct dosage: 20/12.5 Mg (1 In 1 D), Per Oral. Patient was hospitalized.

Dengue Fever, Pneumonia (8309761-2)
on Apr 10, 2012 Female from BRAZIL , 77 years of age, was diagnosed with
  • hypertension
and was treated with Benicar. Directly after, patient experienced the unwanted or unexpected Benicar side effects: dengue fever, pneumonia. Benicar dosage: 20 Mg (20 Mg, 1 In 1 D), Per Oral; 40 Mg (40 Mg, 1 In 1 D), Per Oral. Patient was hospitalized.

Showing 1-25 of 1182 

Benicar Health Episodes

How Can Benicar Affect You?

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my side effects at 40mg's leg muscle cramps , swollen ankles, toes ...Keep Reading

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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.

Benicar Information

Alternative BENICAR Names:OLMESARTA

Active Ingredient: HYDROCHLO OLMESARTA

Benicar Dosage, Warnings, Usage.

Side Effects reported to FDA: 1182. View Benicar Adverse Reports

Benicar safety alerts: 2010

Reported deaths: 27

Reported hospitalizations: 323

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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