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Cozaar (Losartan) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Cozaar (Losartan) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (273)
Death (16)
Life Threatening Events (15)
Disability (10)

Reports by Reaction Type

Dizziness (20)Pain (19)Blood Pressure Increased (19)Asthenia (19)Somnolence (18)Nausea (18)Anaemia (18)Malaise (16)Feeling Abnormal (14)Confusional State (13)Headache (13)Dehydration (13)

Below are a few examples of reports where side effects / adverse reactions may be related to Cozaar (Losartan). For a complete list or a specific selection of reports, please use the links above.

Possible Cozaar side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Diabetes Mellitus, Pain, Disturbance in Attention, Feeling Abnormal, Paraesthesia

Drug(s) suspected as cause:
Cozaar
    Dosage: unk

Xanax
    Dosage: 0.25mg daily

Xanax
    Dosage: half a tablet of 0.5mg



Possible Cozaar side effects in

Reported by a physician from United Kingdom on 2012-08-24

Patient:

Reactions: Dyspnoea, Chest Discomfort, Mouth Ulceration, Chest Pain, Tracheal Disorder, Cough

Drug(s) suspected as cause:
Amlodipine
    Indication: Blood Pressure

Cozaar
    Dosage: 100 mg, unk
    Administration route: Oral
    Indication: Blood Pressure

Losartan Potassium

Other drugs received by patient: Amlodipine Besylate



Possible Cozaar side effects in

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient:

Reactions: Allergy To Chemicals, Rash

Drug(s) suspected as cause:
Cozaar

Other drugs received by patient: Lasix; Betapace



Possible Cozaar side effects in

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient:

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Cozaar



Possible Cozaar side effects in

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient:

Reactions: Therapeutic Response Decreased, Blood Pressure Increased

Drug(s) suspected as cause:
Cozaar

Other drugs received by patient: Atenolol; Hydrochlorothiazide; Metformin HCL; Citalopram Hydrobromide



Possible Cozaar side effects in

Reported by a physician from United Kingdom on 2012-08-23

Patient:

Reactions: Cardiac Arrest

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Cozaar

Other drugs received by patient: Allopurinol



Possible Cozaar side effects in

Reported by a physician from United States on 2012-08-22

Patient:

Reactions: Diarrhoea, Headache, Muscle Spasms

Drug(s) suspected as cause:
Cozaar

Other drugs received by patient: Metoprolol Tartrate; Synthroid; Amodin



Possible Cozaar side effects in

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient:

Reactions: Nausea

Drug(s) suspected as cause:
Cozaar



Possible Cozaar side effects in

Reported by a pharmacist from United Kingdom on 2012-08-22

Patient:

Reactions: Migraine, Anaphylactic Shock, Rash

Drug(s) suspected as cause:
Cozaar
    Dosage: unk
    Administration route: Oral
    Start date: 2012-07-12

Cozaar
    Dosage: unk
    Administration route: Oral
    Start date: 2012-06-01

Cozaar
    Dosage: unk
    Administration route: Oral
    Start date: 2012-06-19

Other drugs received by patient: Molipaxin; Lormetazepam; Estradiol; Metformin



Possible Cozaar side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-20

Patient: male

Reactions: Abdominal Pain, Dyspnoea, Ileus

Adverse event resulted in: death

Drug(s) suspected as cause:
Cozaar
    Indication: Product Used FOR Unknown Indication

Pegasys
    Indication: Product Used FOR Unknown Indication

Ribavirin
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Incivek



Possible Cozaar side effects in 76 year old female

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: 76 year old female, weighing 68.9 kg (151.7 pounds)

Reactions: Joint Swelling, Hypertension

Drug(s) suspected as cause:
Cardura
    Dosage: 5 mg, daily
    Indication: Hypertension

Cozaar
    Dosage: 100 mg, daily
    Indication: Hypertension

Inderal LA
    Dosage: 160 mg, daily
    Indication: Hypertension

Toviaz
    Dosage: 8 mg, daily
    Indication: Hypertonic Bladder
    Start date: 2012-01-01

Other drugs received by patient: Vitamin D



Possible Cozaar side effects in

Reported by a pharmacist from Japan on 2012-08-14

Patient:

Reactions: Drug Eruption

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Allopurinol
    Start date: 1995-01-01

Cozaar
    Administration route: Oral
    Start date: 1995-01-01

Cozaar
    Dosage: unk
    Administration route: Oral
    Start date: 1995-01-01



Possible Cozaar side effects in

Reported by a physician from United States on 2012-08-14

Patient:

Reactions: Myalgia, Gait Disturbance, Hepatic Enzyme Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cozaar



Possible Cozaar side effects in

Reported by a consumer/non-health professional from Italy on 2012-08-10

Patient:

Reactions: Nodal Arrhythmia

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Cozaar
    Dosage: 50 mg, qd
    Administration route: Oral
    Indication: Cardiac Failure
    Start date: 2011-11-01
    End date: 2012-07-24

Kanrenol
    Dosage: 25 mg, qd
    Administration route: Oral
    Indication: Cardiac Failure
    Start date: 2011-11-01
    End date: 2012-07-24

Other drugs received by patient: Aspirin; Escitalopram; Omeprazole; Carvedilol; Lasix; Algix 30mg Compresse Rivestite CON Film; Trazodone HCL; Insulin; Levothyroxine Sodium



Possible Cozaar side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-10

Patient:

Reactions: Abdominal Pain, Dyspnoea, Ileus

Adverse event resulted in: death

Drug(s) suspected as cause:
Cozaar
    Indication: Product Used FOR Unknown Indication

Pegasys
    Indication: Product Used FOR Unknown Indication

Ribavirin
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Telaprevir



Possible Cozaar side effects in

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient:

Reactions: Hypoacusis

Drug(s) suspected as cause:
Cozaar



Possible Cozaar side effects in

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient:

Reactions: Drug Ineffective, Adverse Event

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cozaar



Possible Cozaar side effects in

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient:

Reactions: Blood Pressure Increased, Back Pain, Nausea, Injection Site Joint Swelling, Constipation, Injection Site Joint Pain, Fatigue, Balance Disorder, Dizziness, Hypersomnia

Drug(s) suspected as cause:
Cozaar
    Dosage: unk, prn
    Administration route: Oral
    Indication: Blood Pressure Increased
    Start date: 2012-01-01

Cozaar
    Dosage: unk
    Start date: 2012-06-11

Sodium Hyaluronate
    Dosage: unk, once
    Indication: Osteoarthritis
    Start date: 2012-05-18
    End date: 2012-05-18

Sodium Hyaluronate
    Dosage: unk, once
    Start date: 2012-05-25
    End date: 2012-05-25

Sodium Hyaluronate
    Dosage: unk, once
    Start date: 2012-06-01
    End date: 2012-06-01

Sodium Hyaluronate
    Dosage: unk

Verapamil
    Dosage: unk, prn
    Indication: Blood Pressure Increased
    Start date: 2012-01-01

Verapamil
    Dosage: unk
    Start date: 2012-06-06
    End date: 2012-06-08

Other drugs received by patient: Vitamins (Unspecified)



Possible Cozaar side effects in

Reported by a physician from United States on 2012-08-10

Patient:

Reactions: Cardiac Flutter, Dizziness, Musculoskeletal Stiffness, Feeling Abnormal

Drug(s) suspected as cause:
Cozaar
    Dosage: unk
    Administration route: Oral
    End date: 2012-05-01

Cozaar
    Dosage: 100 mg, qd
    Administration route: Oral
    Start date: 2012-05-01
    End date: 2012-05-01

Cozaar
    Dosage: unk, qam
    Administration route: Oral
    Indication: Hypertension

Other drugs received by patient: Plavix; Metoprolol Tartrate



Possible Cozaar side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-06

Patient:

Reactions: Diabetes Mellitus, Urine Abnormality, Headache, Fatigue, Photophobia, Visual Impairment, Eyelid Ptosis, Dizziness, Muscle Spasms

Drug(s) suspected as cause:
Atacand
    Administration route: Oral

Cozaar

Crestor
    Dosage: unk
    Administration route: Oral

Zocor



Possible Cozaar side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: female

Reactions: Hypersensitivity

Drug(s) suspected as cause:
Cozaar
    Indication: Product Used FOR Unknown Indication

Niaspan
    Dosage: 1xnite
    Indication: Blood Cholesterol

Pravastatin Sodium
    Indication: Blood Cholesterol

Other drugs received by patient: Aspirin; Fish OIL; Lipitor; Lisinopril and Hydrochlorothiazide; Dulcolax; Iron; Protonix; Mega RED; Once-A-DAY Women's Formula Vitamin; Ginko Bilo



Possible Cozaar side effects in female

Reported by a physician from United States on 2012-08-03

Patient: female

Reactions: Anxiety

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aspirin
    Administration route: Oral
    End date: 2012-02-05

Aspirin
    Administration route: Oral
    Start date: 2012-02-06

Brilinta
    Administration route: Oral
    Indication: Coronary Artery Disease
    Start date: 2012-02-06

Buspar
    Administration route: Oral
    Indication: Anxiety

Celexa
    Administration route: Oral
    Indication: Depression

Cozaar
    Administration route: Oral
    Indication: Hypertension

Lipitor
    Administration route: Oral
    Indication: Hypercholesterolaemia

Metformin Hydrochloride
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus

Toprol-XL
    Administration route: Oral
    Indication: Hypertension

Other drugs received by patient: Metoclopramide Hydrochloride; Trazodone Hydrochloride; Carafate; Folic Acid; Nexium; Synthroid; Ativan



Possible Cozaar side effects in

Reported by a pharmacist from United States on 2012-08-02

Patient:

Reactions: Blood Pressure Increased, Paraesthesia Oral, Product Odour Abnormal

Drug(s) suspected as cause:
Cozaar

Other drugs received by patient: Synthroid



Possible Cozaar side effects in

Reported by a pharmacist from United States on 2012-08-02

Patient:

Reactions: Heart Rate Decreased, Renal Impairment, Blood Creatinine Increased

Drug(s) suspected as cause:
Cozaar

Other drugs received by patient: Diltiazem HCL; Lipitor



Possible Cozaar side effects in

Reported by a pharmacist from United States on 2012-08-02

Patient:

Reactions: Malaise, Product Odour Abnormal, Abdominal Pain Upper

Drug(s) suspected as cause:
Cozaar

Other drugs received by patient: Iron (Unspecified)



Possible Cozaar side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-02

Patient:

Reactions: Dyspnoea, Malaise, Fatigue, Swelling, Cardiac Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Amlodipine
    Dosage: 20 mg, unk

Cozaar
    Dosage: 1 df, bid
    Administration route: Oral

Foradil

Other drugs received by patient: Ranitidine; Domperidone



Possible Cozaar side effects in

Reported by a consumer/non-health professional from United States on 2012-08-02

Patient:

Reactions: Drug Ineffective, Blood Pressure Abnormal

Drug(s) suspected as cause:
Cozaar

Other drugs received by patient: Cenestin



Possible Cozaar side effects in

Reported by a consumer/non-health professional from Denmark on 2012-08-02

Patient:

Reactions: Renal Impairment, Blood Creatinine Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cozaar
    Dosage: 50 mg, qd
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-06-08

Januvia
    Dosage: dosis: 100 mg 1 gang dagligt, styrke: 100
    Administration route: Oral
    End date: 2012-06-08

Januvia
    Dosage: 100 mg, qd
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    Start date: 2012-06-08

Losartan Potassium
    Administration route: Oral
    Indication: Hypertension
    End date: 2012-06-08

Other drugs received by patient: Simvastatin; Aspirin; Magnyl; Carvedilol



Possible Cozaar side effects in

Reported by a consumer/non-health professional from United States on 2012-08-01

Patient:

Reactions: Renal Failure Acute

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Cisplatin
    Indication: Metastatic Gastric Cancer

Cozaar
    Dosage: unk
    Administration route: Oral
    Indication: Hypertension
    Start date: 2008-01-01
    End date: 2012-01-01

Gimeracil (+) Oteracil Potassium (+) Tegafur
    Indication: Metastatic Gastric Cancer

Other drugs received by patient: Morphine Sulfate; Domperidone; Nutritional Supplements; Gabapentin; Nortriptyline Hydrochloride; Morphine Sulfate; Dipyrone INJ; Alprazolam; Fluoxetine Hydrochloride; Lorazepam; Omeprazole; Domperidone; Metoclopramide; Acetaminophen; Metoclopramide



Possible Cozaar side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-31

Patient:

Reactions: Iron Deficiency Anaemia, Gastric Ulcer, Abdominal Pain Upper

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Acetaminophen

Berodual

Bricanyl

Cozaar
    Administration route: Oral

Digoxin

Duovent

Fluticasone Propionate / Salmeterol

Furosemide

Isoptin

Morphine Sulfate

Oxazepam

Pradaxa
    Dosage: 150 mg, bid
    Administration route: Oral

Prednisolone

Sertraline Hydrochloride

Simvastatin

Spiriva

Zolpidem Tatrate

Other drugs received by patient: Potassium Chloride

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