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Lotrel (Amlodipine / Benazepril) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Lotrel (Amlodipine / Benazepril) 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 (35)
Death (1)
Life Threatening Events (1)
Disability (2)

Reports by Reaction Type

Drug Ineffective (5)Blood Pressure Increased (5)Headache (4)Dizziness (4)Cough (4)Rash (4)LIP Swelling (3)Urticaria (3)Drug Hypersensitivity (3)Cerebrovascular Accident (3)Swelling (3)Drug Eruption (2)

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

Possible Lotrel side effects in 62 year old female

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

Patient: 62 year old female

Reactions: Allergic Oedema, Drug Tolerance Increased, Urticaria, Psoriasis, Musculoskeletal Discomfort, DRY Eye, Angle Closure Glaucoma

Drug(s) suspected as cause:
Humira
    Indication: Psoriasis

Lipitor
    Indication: Product Used FOR Unknown Indication
    End date: 2012-07-01

Lotrel
    Indication: Product Used FOR Unknown Indication

Zetia
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-13

Other drugs received by patient: Losartan Potassium; Potassium; Nopalea; Amlodipine; Carvedilol; Celexa



Possible Lotrel side effects in 11 month old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient: 11 month old male

Reactions: Respiratory Rate Increased, Vomiting, Unresponsive To Stimuli, Tachycardia, Condition Aggravated, Asphyxia, Overdose, Cyanosis, Drug Administered To Patient of Inappropriate AGE, Circulatory Collapse, Bradycardia, Blood Pressure Decreased, Cardiac Arrest, Lethargy

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Lotrel



Possible Lotrel side effects in 62 year old female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 62 year old female

Reactions: Pharyngeal Oedema, Drug Effect Decreased, Urticaria, Psoriasis, Musculoskeletal Discomfort, DRY Eye, Angle Closure Glaucoma

Drug(s) suspected as cause:
Humira
    Indication: Psoriasis

Lipitor
    Indication: Product Used FOR Unknown Indication
    End date: 2012-07-01

Lotrel
    Indication: Product Used FOR Unknown Indication

Zetia
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-13

Other drugs received by patient: Amlodipine; Celexa; Carvedilol; Losartan Potassium; Nopalea; Potassium



Possible Lotrel side effects in male

Reported by a pharmacist from United States on 2012-08-23

Patient: male, weighing 81.6 kg (179.6 pounds)

Reactions: LIP Swelling

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lotrel



Possible Lotrel side effects in 87 year old female

Reported by a pharmacist from United States on 2012-07-27

Patient: 87 year old female, weighing 75.0 kg (165.0 pounds)

Reactions: Swollen Tongue

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lotrel

Other drugs received by patient: Lasix; Coreg; Klonopin; Azithromycin; Methimazole; Amlodipine; Symbyax



Possible Lotrel side effects in female

Reported by a physician from United States on 2012-07-09

Patient: female

Reactions: Drug Hypersensitivity

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

Clindamycin HCL
    Dosage: unk

Codeine Sulfate
    Dosage: unk

Erythromycin
    Dosage: unk

Iodine
    Dosage: unk

Lotrel
    Dosage: unk

Methotrexate Sodium
    Dosage: unk

Niacin
    Dosage: unk

Norco
    Dosage: unk

Toprol-XL
    Dosage: unk



Possible Lotrel side effects in male

Reported by a physician from United States on 2012-07-03

Patient: male

Reactions: Myalgia, Rhabdomyolysis, Myoglobin Blood Increased

Drug(s) suspected as cause:
Lotrel



Possible Lotrel side effects in 73 year old female

Reported by a consumer/non-health professional from United States on 2012-06-25

Patient: 73 year old female, weighing 84.8 kg (186.6 pounds)

Reactions: Product Formulation Issue, Product Quality Issue, Product Substitution Issue, Pruritus, Urticaria, Visual Acuity Reduced, AGE-Related Macular Degeneration, Vision Blurred

Drug(s) suspected as cause:
Lotrel



Possible Lotrel side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-21

Patient: female, weighing 88.0 kg (193.6 pounds)

Reactions: Dyspnoea, Fatigue, Drug Ineffective, Musculoskeletal Stiffness, Arterial Occlusive Disease, Disease Progression, Cardiac Disorder

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Diovan
    Dosage: 180 mg, daily
    Indication: Hypertension
    Start date: 2007-12-01

Diovan
    Dosage: 320 mg, daily

Lipitor
    Dosage: unk
    Indication: Blood Cholesterol Increased

Lotrel
    Dosage: unk
    Indication: Hypertension
    End date: 2007-12-01

Procardia XL
    Dosage: 60 mg, daily
    Indication: Hypertension
    Start date: 2007-12-01

Other drugs received by patient: Levothyroxine; Plavix; Ranexa; Aspirin; Lasix; Alprazolam; Nexium



Possible Lotrel side effects in 66 year old male

Reported by a pharmacist from United States on 2012-06-19

Patient: 66 year old male, weighing 88.9 kg (195.6 pounds)

Reactions: LIP Swelling, JAW Disorder

Drug(s) suspected as cause:
Lotrel

Other drugs received by patient: Aspirin; Metoprolol Tartrate; Multi-Vitamin; Hydrochlorothiazide; Cetirizine; Crestor; Nexium



Possible Lotrel side effects in

Reported by a consumer/non-health professional from United States on 2012-06-13

Patient:

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Ciprofloxacin HCL
    Dosage: unk

Clindamycin HCL
    Dosage: unk

Codeine Sulfate
    Dosage: unk

Erythromycin
    Dosage: unk

Iodine
    Dosage: unk

Lotrel
    Dosage: unk

Methotrexate Sodium
    Dosage: unk

Niacin
    Dosage: unk

Norco
    Dosage: unk



Possible Lotrel side effects in female

Reported by a individual with unspecified qualification from United States on 2012-06-05

Patient: female, weighing 79.4 kg (174.6 pounds)

Reactions: Renal Impairment

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

Drug(s) suspected as cause:
Benicar
    Dosage: 40 mg 1 a day don't have old bottles
    Indication: Blood Pressure
    Start date: 2010-07-07
    End date: 2011-01-31

Lotrel
    Dosage: 10/40 1 a day don't have old bottles
    Indication: Blood Pressure
    Start date: 2010-07-07
    End date: 2011-01-31



Possible Lotrel side effects in

Reported by a consumer/non-health professional from United States on 2012-04-18

Patient:

Reactions: Cystitis Interstitial

Drug(s) suspected as cause:
Lotrel



Possible Lotrel side effects in 67 year old male

Reported by a consumer/non-health professional from United States on 2012-04-05

Patient: 67 year old male

Reactions: Blood Pressure Increased, Drug Ineffective

Drug(s) suspected as cause:
Lotrel

Other drugs received by patient: Exforge; Antihypertensives (NO Ingredients / Substances)



Possible Lotrel side effects in male

Reported by a consumer/non-health professional from United States on 2012-04-05

Patient: male

Reactions: Blood Pressure Increased, Muscular Weakness, Back Disorder

Drug(s) suspected as cause:
Lotrel

Other drugs received by patient: Excedrin (Caffeine, Paracetamol); Insulin (Insulin); Bayer Back + Body; Milk Thistle; Normodyne; Aspirin



Possible Lotrel side effects in 56 year old female

Reported by a consumer/non-health professional from United States on 2012-04-05

Patient: 56 year old female

Reactions: Chest Discomfort, Drug Ineffective, Headache, Hypoaesthesia, Flushing, Malaise, Palpitations, Chest Pain, Hallucination, Blood Pressure Fluctuation, Blood Glucose Increased, Cough

Drug(s) suspected as cause:
Benicar
    Dosage: once daily, oral
    Administration route: Oral
    Indication: Blood Pressure

Diovan HCT
    Dosage: 1 df, qd, oral
    Administration route: Oral
    Indication: Blood Pressure

Hydrochlorothiazide
    Dosage: 75 mg, qd, oral
    Administration route: Oral

Lisinopril
    Dosage: qd, oral
    Administration route: Oral
    Indication: Blood Pressure

Lotrel
    Dosage: qd, oral
    Administration route: Oral
    Indication: Blood Pressure

Other drugs received by patient: Codeine Sulfate; Glipizide



Possible Lotrel side effects in 66 year old male

Reported by a consumer/non-health professional from United States on 2012-04-05

Patient: 66 year old male

Reactions: Weight Decreased, Hypotension, Dizziness, Fall

Drug(s) suspected as cause:
Lotrel

Other drugs received by patient: Allopurinol; Iron (Iron); Prilosec; Levothyroxine Sodium



Possible Lotrel side effects in 42 year old male

Reported by a consumer/non-health professional from United States on 2012-04-05

Patient: 42 year old male

Reactions: Blood Pressure Increased, Dyspnoea, Malaise, Heart Rate Increased, Metabolic Disorder, Cough

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lotrel

Other drugs received by patient: Atenolol; Protonix; Pravachol



Possible Lotrel side effects in 56 year old male

Reported by a consumer/non-health professional from United States on 2012-04-05

Patient: 56 year old male

Reactions: LIP Swelling, Angioedema, Retching, Headache, Oropharyngeal Pain, Swollen Tongue, Protrusion Tongue, Dysphonia, Swelling, Dizziness, Feeling Abnormal, Cough

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Amlodipine + Clotrimazole

Avelox

Lotrel
    Dosage: 1 df, qd
    Start date: 2011-03-01

Other drugs received by patient: Seroquel; Hydroxyzine Pamoate; Pristiq; Sumatriptan (Sumatriptan) Injection; Xanax; Topiramate; Dibalproez ER; Omeprazole



Possible Lotrel side effects in female

Reported by a consumer/non-health professional from United States on 2012-04-05

Patient: female

Reactions: Blood Pressure Inadequately Controlled, Dehydration, Hypertension

Drug(s) suspected as cause:
Lotrel
    Dosage: 10/2.5mg

Tenormin

Toprol-XL



Possible Lotrel side effects in female

Reported by a physician from United States on 2012-04-04

Patient: female

Reactions: Drug Hypersensitivity, Contrast Media Allergy

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

Potassium Pencillin G
    Dosage: unk



Possible Lotrel side effects in female

Reported by a physician from United States on 2012-02-22

Patient: female

Reactions: Amnesia, Convulsion

Drug(s) suspected as cause:
Lotrel

Other drugs received by patient: Simvastatin; Alendronate Sodium; Namenda



Possible Lotrel side effects in male

Reported by a physician from United States on 2012-02-01

Patient: male, weighing 85.3 kg (187.6 pounds)

Reactions: Hypertensive Encephalopathy, Dermatitis Atopic, Rash, Cerebrovascular Accident, Speech Disorder, Dermatitis, Cerebral Infarction, Hypertension

Drug(s) suspected as cause:
Diovan HCT
    Dosage: unk
    Indication: Hypertension

Lotrel
    Dosage: unk
    Indication: Hypertension

Other drugs received by patient: Lipitor



Possible Lotrel side effects in female

Reported by a consumer/non-health professional from United States on 2012-02-01

Patient: female

Reactions: Bedridden, HIP Fracture, Fall

Drug(s) suspected as cause:
Lotrel

Other drugs received by patient: Buspar; Citalopram Hydrobromide; Aggrenox



Possible Lotrel side effects in male

Reported by a consumer/non-health professional from United States on 2012-01-18

Patient: male

Reactions: Muscle Contractions Involuntary, Tardive Dyskinesia

Drug(s) suspected as cause:
Lotrel



Possible Lotrel side effects in female

Reported by a consumer/non-health professional from United States on 2012-01-11

Patient: female

Reactions: Drug Eruption, Skin Exfoliation, Skin Burning Sensation

Drug(s) suspected as cause:
Lotrel
    Dosage: 10/40 mg 2 df, unk

Lotrel
    Dosage: 10/40 mg 1 df,(1/day)

Other drugs received by patient: Atenolol; Lipitor; Atenolol



Possible Lotrel side effects in 52 year old male

Reported by a consumer/non-health professional from United States on 2011-12-22

Patient: 52 year old male, weighing 142.9 kg (314.3 pounds)

Reactions: Cough

Drug(s) suspected as cause:
Lotrel



Possible Lotrel side effects in female

Reported by a consumer/non-health professional from United States on 2011-12-21

Patient: female, weighing 86.2 kg (189.6 pounds)

Reactions: Drug Eruption, Skin Exfoliation, Erythema

Drug(s) suspected as cause:
Atenolol
    Dosage: 1 daily 047
    Indication: Hypertension
    Start date: 2007-12-01
    End date: 2011-04-11

Lotrel
    Dosage: 1 daily 047
    Indication: Hypertension
    Start date: 2007-12-01
    End date: 2011-04-11



Possible Lotrel side effects in female

Reported by a consumer/non-health professional from United States on 2011-11-24

Patient: female

Reactions: Hypersensitivity, Swelling, Rash, Headache

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

Calan
    Dosage: unk
    Indication: Hypertension

Cardura
    Dosage: unk
    Indication: Hypertension

Cozaar
    Dosage: unk
    Indication: Hypertension

Diovan
    Dosage: unk

Irbesartan
    Dosage: unk

Lotrel
    Dosage: unk
    Indication: Hypertension

Other drugs received by patient: Procardia XL; Procardia XL; Labetalol



Possible Lotrel side effects in male

Reported by a consumer/non-health professional from United States on 2011-11-23

Patient: male, weighing 199.0 kg (437.8 pounds)

Reactions: Blood Pressure Increased, Drug Ineffective, Dizziness, Cerebrovascular Accident

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Amlodipine Besylate and Benazepril HCL
    Dosage: 1 df, qd

Lotrel
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: Hypertension

Other drugs received by patient: Lovaza; Alendronate Sodium; Acetylsalicylic Acid SRT; Centrum; Calcium; Aspirin

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