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Altace (Ramipril) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Altace (Ramipril) 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 (357)
Death (22)
Life Threatening Events (45)
Disability (16)

Reports by Reaction Type

Drug Interaction (46)Dyspnoea (37)Renal Failure Acute (36)Drug Ineffective (35)Hyponatraemia (24)Hypotension (23)Oedema Peripheral (21)Cough (21)Angioedema (21)Palpitations (20)Vomiting (20)Nausea (20)

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

Possible Altace side effects in 58 year old female

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

Patient: 58 year old female

Reactions: Dysgeusia, Dyspnoea, Anaphylactic Shock, Swollen Tongue

Drug(s) suspected as cause:
Altace



Possible Altace side effects in male

Reported by a physician from Canada on 2012-08-13

Patient: male, weighing 104.0 kg (228.8 pounds)

Reactions: Asthma, Hepatic Neoplasm Malignant, Benign Prostatic Hyperplasia

Adverse event resulted in: death

Drug(s) suspected as cause:
Altace
    Indication: Product Used FOR Unknown Indication
    Start date: 2006-02-23

Crestor
    Indication: Product Used FOR Unknown Indication
    Start date: 2006-02-23

Effexor XR
    Indication: Product Used FOR Unknown Indication
    Start date: 2007-05-09

Hydrochlorothiazide
    Dosage: 50 mg 1 qd
    Indication: Product Used FOR Unknown Indication

Kaletra
    Indication: HIV Infection

Kaletra
    Dosage: 200/50; stopped 4 months prior to death
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2007-11-07
    End date: 2010-09-10

Levothyroxine Sodium
    Indication: Product Used FOR Unknown Indication
    Start date: 2006-02-23

Qvar 40
    Dosage: 100/ug/pf 2 pf
    Indication: Product Used FOR Unknown Indication
    Start date: 2008-06-23

Truvada
    Dosage: 100/ug/pf 2 pf
    Indication: Product Used FOR Unknown Indication
    Start date: 2007-11-08

Other drugs received by patient: Crestor; Serevent; Valproate Sodium; Ventolin; Norvir; Potassium Chloride; Ranitidine; Intelence; Procar; Lamictal; Rabeprazole Sodium; Prezista



Possible Altace side effects in male

Reported by a physician from Canada on 2012-08-10

Patient: male, weighing 104.0 kg (228.8 pounds)

Reactions: Asthma, Hepatic Neoplasm Malignant, Benign Prostatic Hyperplasia

Adverse event resulted in: death

Drug(s) suspected as cause:
Altace
    Indication: Product Used FOR Unknown Indication
    Start date: 2006-02-23

Crestor
    Indication: Product Used FOR Unknown Indication
    Start date: 2006-02-23

Effexor XR
    Indication: Product Used FOR Unknown Indication
    Start date: 2007-05-09

Hydrochlorothiazide
    Indication: Product Used FOR Unknown Indication

Kaletra
    Dosage: 200/50; stopped 4 months prior to death
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2007-11-07
    End date: 2010-09-10

Kaletra
    Indication: HIV Infection

Levothyroxine Sodium
    Indication: Product Used FOR Unknown Indication
    Start date: 2006-02-23

Qvar 40
    Dosage: 100/ug/pf 2 pf
    Indication: Product Used FOR Unknown Indication
    Start date: 2008-06-23

Truvada
    Dosage: 200/300mg
    Indication: Product Used FOR Unknown Indication
    Start date: 2007-11-08

Other drugs received by patient: Valproate Sodium; Rabeprazole Sodium; Lamictal; Norvir; Crestor; Potassium Chloride; Intelence; Serevent; Ventolin; Procar; Prezista; Ranitidine



Possible Altace side effects in 62 year old male

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

Patient: 62 year old male

Reactions: Underdose, Platelet Count Decreased, Hypertension

Drug(s) suspected as cause:
Altace
    Dosage: unk, unk

Excedrin (Migraine)
    Dosage: 1-2 df, prn
    Administration route: Oral
    Indication: Headache



Possible Altace side effects in 44 year old male

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-01

Patient: 44 year old male, weighing 86.0 kg (189.2 pounds)

Reactions: Cerebrovascular Accident

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Altace
    Dosage: 1 df, qd (10 mg)

Rasilez
    Dosage: 1 df, qd
    Administration route: Oral



Possible Altace side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-27

Patient:

Reactions: LIP Swelling, Weight Decreased, Pruritus, Oedema Peripheral, Swelling, Rash

Drug(s) suspected as cause:
Altace

Amaryl

Garlic

Januvia
    Administration route: Oral

Lantus
    Dosage: 10 df, qd

Metformin Hydrochloride



Possible Altace side effects in

Reported by a consumer/non-health professional from United States on 2012-07-27

Patient:

Reactions: LIP Swelling, Weight Decreased, Pruritus, Oedema Peripheral, Swelling, Rash

Drug(s) suspected as cause:
Altace

Amaryl

Garlic

Januvia
    Administration route: Oral

Lantus
    Dosage: 10 df, hs

Metformin Hydrochloride



Possible Altace side effects in male

Reported by a physician from United States on 2012-07-23

Patient: male

Reactions: Angioedema, Urticaria, Drug Hypersensitivity

Drug(s) suspected as cause:
Altace



Possible Altace side effects in

Reported by a consumer/non-health professional from United States on 2012-07-18

Patient:

Reactions: Dyspnoea, Dizziness, Asthenia

Drug(s) suspected as cause:
Altace
    Dosage: unk-2011 2011-ong

Coreg
    Dosage: unk-2011 2011-ong

Lantus
    Dosage: 1df=100 iu/ml unk-2011 2011-ong,sc lantus inj sol

Warfarin Sodium
    Dosage: unk-2011 2011-ong

Zocor
    Dosage: unk-2011 2011-ong



Possible Altace side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-18

Patient: female, weighing 81.2 kg (178.6 pounds)

Reactions: Migraine, Intervertebral Disc Protrusion, Hiatus Hernia, Angina Pectoris, Wrist Fracture, Hypoglycaemia, Renal Failure Chronic, Cerebrovascular Accident, Fall, Nephritis, Anxiety, Weight Increased, Body Height Decreased, Euphoric Mood, Palpitations, Weight Fluctuation, Back Injury

Drug(s) suspected as cause:
Altace
    Dosage: 10 mg, 1x/day
    Indication: Hypertension

Lyrica
    Dosage: 75 mg, 4x/day
    Administration route: Oral
    Indication: Fibromyalgia
    Start date: 2010-06-01

Lyrica
    Dosage: unk
    Administration route: Oral

Lyrica
    Dosage: 150 mg, 2x/day
    Administration route: Oral
    Indication: Nerve Injury

Other drugs received by patient: Plaquenil; Vitamin D; Vitamin B Complex CAP; Chlordiazepoxide HCL W / Clidinium Bromide; Amaryl; Albuterol; Potassium Chloride; Furosemide; Glimepiride; Foradil; Proair HFA; Calcium Citrate; Klonopin; Klonopin; Cytoxan; Amaryl; Combivent; Atenolol; Clonazepam; Ergocalciferol; Combivent; Albuterol; Albuterol Sulfate; Lasix; Protonix; Hydrocodone; Albuterol; Albuterol; Albuterol; Proair HFA; Hydrocodone; Calcium Acetate; Folic Acid; Vitamin B-12; Compazine; Protonix; Plaquenil; Combivent; Chlordiazepoxide HCL W / Clidinium Bromide; Albuterol Sulfate; Foradil; Librax; Tenormin



Possible Altace side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-12

Patient: female, weighing 81.2 kg (178.6 pounds)

Reactions: Intervertebral Disc Protrusion, Migraine, Hiatus Hernia, Angina Pectoris, Wrist Fracture, Hypoglycaemia, Cerebrovascular Accident, Renal Failure Chronic, Fall, Nephritis, Anxiety, Weight Increased, Body Height Decreased, Euphoric Mood, Palpitations, Weight Fluctuation, Back Injury

Drug(s) suspected as cause:
Altace
    Dosage: 10 mg, 1x/day
    Indication: Hypertension

Lyrica
    Dosage: 150 mg, 2x/day
    Administration route: Oral
    Indication: Nerve Injury

Lyrica
    Dosage: 75 mg, 4x/day
    Administration route: Oral
    Indication: Fibromyalgia
    Start date: 2010-06-01

Lyrica
    Dosage: unk
    Administration route: Oral

Other drugs received by patient: Amaryl; Combivent; Atenolol; Calcium Acetate; Foradil; Plaquenil; Librax; Proair HFA; Albuterol; Vitamin B-12; Protonix; Plaquenil; Hydrocodone; Combivent; Combivent; Albuterol; Vitamin D; Folic Acid; Chlordiazepoxide HCL W / Clidinium Bromide; Furosemide; Ergocalciferol; Klonopin; Klonopin; Amaryl; Hydrocodone; Albuterol; Chlordiazepoxide HCL W / Clidinium Bromide; Glimepiride; Albuterol Sulfate; Albuterol Sulfate; Clonazepam; Proair HFA; Cytoxan; Protonix; Albuterol; Albuterol; Potassium Chloride; Foradil; Compazine; Lasix; Vitamin B Complex CAP; Tenormin; Calcium Citrate



Possible Altace side effects in male

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

Patient: male

Reactions: Angioedema, Drug Hypersensitivity, Urticaria

Drug(s) suspected as cause:
Altace



Possible Altace side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-29

Patient: female

Reactions: Eye Haemorrhage, Blood Pressure Increased, Brain Neoplasm Malignant

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

Ramipril
    Dosage: unk
    Indication: Hypertension



Possible Altace side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-27

Patient: female

Reactions: Fatigue, Heart Rate Irregular

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

Ramipril
    Dosage: unk

Ramipril
    Dosage: unk



Possible Altace side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-27

Patient: female

Reactions: Blood Pressure Increased, Eye Haemorrhage, Brain Neoplasm Malignant

Drug(s) suspected as cause:
Altace
    Indication: Hypertension

Ramipril
    Indication: Hypertension



Possible Altace side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-22

Patient: female, weighing 44.0 kg (96.8 pounds)

Reactions: Alopecia

Drug(s) suspected as cause:
Altace

Other drugs received by patient: Thyroid TAB



Possible Altace side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-22

Patient: female

Reactions: Eye Haemorrhage, Blood Pressure Increased, Brain Neoplasm Malignant

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

Ramipril
    Dosage: unk
    Indication: Hypertension



Possible Altace side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-20

Patient: female

Reactions: Fatigue, Heart Rate Irregular

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

Ramipril
    Dosage: unk

Ramipril
    Dosage: unk



Possible Altace side effects in

Reported by a consumer/non-health professional from United States on 2012-06-11

Patient:

Reactions: Urticaria, Drug Hypersensitivity

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

Potassium Penicillin G
    Dosage: unk



Possible Altace side effects in 59 year old female

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

Patient: 59 year old female

Reactions: Swelling Face, Dyspnoea, Angioedema, Anaphylactic Reaction, Chills, Urinary Tract Infection, Pyrexia, Blood Sodium Decreased

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Altace
    Dosage: 5 mg, 1x/day
    Administration route: Oral
    Indication: Hypertension

Metformin Hydrochloride
    Dosage: 1 g, 2x/day
    Administration route: Oral
    Indication: Diabetes Mellitus

Saxagliptin
    Dosage: 5 mg, 1x/day
    Administration route: Oral
    Indication: Diabetes Mellitus

Other drugs received by patient: Glimepiride; Multi-Vitamin; Calcium



Possible Altace side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-05

Patient: female, weighing 68.0 kg (149.7 pounds)

Reactions: Blood Iron Decreased, Serum Serotonin Decreased

Drug(s) suspected as cause:
Altace

Other drugs received by patient: Nature Made



Possible Altace side effects in 74 year old male

Reported by a consumer/non-health professional from Canada on 2012-05-25

Patient: 74 year old male

Reactions: Prostate Cancer

Drug(s) suspected as cause:
Alfuzosin HCL
    Dosage: at bedtime
    Administration route: Oral
    Indication: Urinary Tract Disorder
    Start date: 2007-01-01
    End date: 2012-05-15

Altace
    Administration route: Oral
    Indication: Hypertension
    Start date: 2009-01-01

Avalide
    Dosage: 1 df= 300/12.5mg
    Administration route: Oral
    Indication: Hypertension
    Start date: 2009-01-01

Lantus
    Dosage: 36iu in morning, 38iu at bedtime
    Indication: Diabetes Mellitus
    Start date: 2007-01-01

Testim
    Administration route: Topical
    Start date: 2011-07-01
    End date: 2011-12-12

Other drugs received by patient: Clonidine; Novorapid; Avodart; Atenolol; Amlodipine Besylate



Possible Altace side effects in 74 year old male

Reported by a consumer/non-health professional from Canada on 2012-05-24

Patient: 74 year old male

Reactions: Prostate Cancer, Drug Administration Error

Drug(s) suspected as cause:
Alfuzosin HCL
    Dosage: 10 mg, at bedtime
    Administration route: Oral
    Indication: Urinary Tract Disorder
    Start date: 2007-01-01
    End date: 2012-05-15

Altace
    Dosage: 10 mg, daily
    Administration route: Oral
    Indication: Hypertension
    Start date: 2009-01-01

Avalide
    Dosage: 24 mg, daily
    Administration route: Oral
    Indication: Hypertension
    Start date: 2009-01-01

Lantus
    Dosage: 74 iu daily, (36 iu in the morning and 38 iu at bedtime)
    Indication: Diabetes Mellitus
    Start date: 2007-01-01

Testim
    Dosage: unk
    Administration route: Topical
    Indication: Hormone Replacement Therapy
    Start date: 2011-07-01
    End date: 2011-12-12

Other drugs received by patient: Novorapid; Avodart; Clonidine; Atenolol; Amlodipine



Possible Altace side effects in 67 year old male

Reported by a consumer/non-health professional from United States on 2012-05-23

Patient: 67 year old male, weighing 123.0 kg (270.6 pounds)

Reactions: Angioedema, Type 2 Diabetes Mellitus, Dyspnoea, Effusion, Diabetic Nephropathy, Inner Ear Disorder, Herpes Zoster, Weight Increased, Autoimmune Disorder, Auricular Swelling, Oedema Peripheral, Ear Pain, Otorrhoea, Polychondritis, Neuralgia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Altace
    Indication: Hypertension

Hydralazine HCL
    Indication: Hypertension
    Start date: 2009-01-01

Losartan Potassium
    Indication: Hypertension

Norvasc
    Indication: Hypertension



Possible Altace side effects in 74 year old male

Reported by a consumer/non-health professional from Canada on 2012-05-21

Patient: 74 year old male

Reactions: Prostate Cancer, Drug Administration Error

Drug(s) suspected as cause:
Alfuzosin HCL
    Administration route: Oral
    Indication: Urinary Tract Disorder
    Start date: 2007-01-01
    End date: 2012-05-15

Altace
    Administration route: Oral
    Indication: Hypertension
    Start date: 2009-01-01

Avalide
    Administration route: Oral
    Indication: Hypertension
    Start date: 2009-01-01

Lantus
    Dosage: dose- 36 iu in the morning and 38 iu at bedtime
    Start date: 2007-01-01

Testim
    Administration route: Topical
    Indication: Hormone Replacement Therapy
    Start date: 2011-07-01
    End date: 2011-12-12

Other drugs received by patient: Avodart; Atenolol; Clonidine; Amlodipine Besylate; Novorapid



Possible Altace side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-11

Patient: male, weighing 123.0 kg (270.6 pounds)

Reactions: Ear Discomfort, Swelling Face, Dyspnoea, Angioedema, Type 2 Diabetes Mellitus, Middle Ear Effusion, Diabetic Nephropathy, Herpes Zoster, Weight Increased, Autoimmune Disorder, Auricular Swelling, Oedema Peripheral, Ear Pain, Otorrhoea, Polychondritis, Neuralgia

Adverse event resulted in: hospitalization

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

Hydralazine HCL
    Dosage: unk
    Indication: Cardiovascular Disorder

Losartan Potassium
    Dosage: unk
    Indication: Hypertension

Norvasc
    Dosage: unk
    Indication: Hypertension



Possible Altace side effects in 67 year old

Reported by a individual with unspecified qualification from United States on 2012-05-11

Patient: 67 year old , weighing 123.0 kg (270.6 pounds)

Reactions: LIP Swelling, Diabetic Nephropathy, Herpes Zoster, Weight Increased, Nasal Oedema, Auricular Swelling, Oedema Peripheral, Otorrhoea, Polychondritis, Ear Discomfort, Swelling Face, Angioedema, Type 2 Diabetes Mellitus, Middle Ear Effusion, Autoimmune Disorder, Ear Pain, Neuralgia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Altace
    Indication: Hypertension

Losartan Potassium
    Indication: Hypertension

Norvasc
    Indication: Hypertension

Other drugs received by patient: Hydralazine HCL



Possible Altace side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-03

Patient: male, weighing 123.0 kg (270.6 pounds)

Reactions: Ear Discomfort, Swelling Face, Type 2 Diabetes Mellitus, Dyspnoea, Angioedema, Middle Ear Effusion, Diabetic Nephropathy, Herpes Zoster, Autoimmune Disorder, Weight Increased, Auricular Swelling, Oedema Peripheral, Otorrhoea, Ear Pain, Polychondritis, Neuralgia

Adverse event resulted in: hospitalization

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

Hydralazine HCL
    Dosage: unk
    Indication: Cardiovascular Disorder

Losartan Potassium
    Dosage: unk
    Indication: Hypertension

Norvasc
    Dosage: unk
    Indication: Hypertension



Possible Altace side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-02

Patient: male, weighing 74.8 kg (164.6 pounds)

Reactions: Pruritus, Cough

Drug(s) suspected as cause:
Altace



Possible Altace side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-02

Patient: male, weighing 74.8 kg (164.6 pounds)

Reactions: Back Pain, Pruritus, Oropharyngeal Discomfort, Abdominal Discomfort, Weight Increased, Neck Pain, Diarrhoea, Dyspepsia, Feeling Abnormal

Drug(s) suspected as cause:
Altace

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