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Levitra (Vardenafil) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Levitra (Vardenafil) 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 (376)
Death (4)
Life Threatening Events (2)
Disability (4)

Reports by Reaction Type

Drug Ineffective (123)Erectile Dysfunction (76)Headache (42)Flushing (23)NO Adverse Event (20)Nasal Congestion (15)Tinnitus (10)Dizziness (10)Nausea (10)Vision Blurred (9)Feeling Abnormal (9)Abdominal Discomfort (8)

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

Possible Levitra side effects in male

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

Patient: male

Reactions: Genital Discomfort

Drug(s) suspected as cause:
Levitra



Possible Levitra side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: male

Reactions: Erectile Dysfunction

Drug(s) suspected as cause:
Levitra



Possible Levitra side effects in male

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

Patient: male

Reactions: Disorientation, Erythema

Drug(s) suspected as cause:
Levitra



Possible Levitra side effects in male

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

Patient: male

Reactions: Dizziness

Drug(s) suspected as cause:
Levitra



Possible Levitra side effects in male

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

Patient: male

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Levitra



Possible Levitra side effects in 71 year old male

Reported by a pharmacist from United States on 2012-08-27

Patient: 71 year old male

Reactions: Abdominal Discomfort, Nausea

Drug(s) suspected as cause:
Levitra
    Dosage: half or quarter of 20mg tablet
    Administration route: Oral
    Start date: 2012-05-26

Levitra
    Dosage: 0.5 df, unk
    Administration route: Oral
    Start date: 2012-05-26

Other drugs received by patient: Finasteride; Verapamil



Possible Levitra side effects in 75 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: 75 year old male

Reactions: Erectile Dysfunction

Drug(s) suspected as cause:
Levitra

Other drugs received by patient: Fish OIL; EYE Drops



Possible Levitra side effects in male

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

Patient: male

Reactions: Pain, Optic Ischaemic Neuropathy, Headache, Anxiety, Anhedonia, Activities of Daily Living Impaired, Blindness Unilateral, Vision Blurred, Injury

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Levitra



Possible Levitra side effects in 50 year old male

Reported by a pharmacist from Canada on 2012-08-23

Patient: 50 year old male, weighing 86.2 kg (189.6 pounds)

Reactions: Visual Impairment, Headache, Influenza Like Illness

Drug(s) suspected as cause:
Levitra



Possible Levitra side effects in

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient:

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Levitra



Possible Levitra side effects in 30 year old male

Reported by a physician from United States on 2012-08-21

Patient: 30 year old male

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Levitra



Possible Levitra side effects in male

Reported by a pharmacist from United Kingdom on 2012-08-20

Patient: male

Reactions: Dyspnoea, Malaise, Dizziness, Renal Failure Acute

Drug(s) suspected as cause:
Levitra



Possible Levitra side effects in 41 year old male

Reported by a physician from United States on 2012-08-17

Patient: 41 year old male, weighing 83.9 kg (184.6 pounds)

Reactions: Flat Affect, Drug Ineffective, Schizophrenia, Paranoid Type, Feeling Abnormal, Loss of Libido

Drug(s) suspected as cause:
Seroquel
    Indication: Schizophrenia

Viagra
    Dosage: unk, as needed
    Administration route: Oral
    Indication: Loss of Libido

Zoloft
    Dosage: unk
    Indication: Agitation

Seroquel
    Dosage: unk
    Indication: Sleep Disorder

Levitra
    Dosage: unk

Cialis
    Dosage: unk



Possible Levitra side effects in 63 year old male

Reported by a physician from Germany on 2012-08-15

Patient: 63 year old male, weighing 92.0 kg (202.4 pounds)

Reactions: Amaurosis

Drug(s) suspected as cause:
Levitra



Possible Levitra side effects in 57 year old male

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient: 57 year old male

Reactions: Nasal Congestion, Headache, Erectile Dysfunction

Drug(s) suspected as cause:
Levitra

Other drugs received by patient: Anti-Diabetics; Actos; Januvia



Possible Levitra side effects in 46 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-14

Patient: 46 year old male

Reactions: Retinal Vein Occlusion

Drug(s) suspected as cause:
Levitra



Possible Levitra side effects in 41 year old male

Reported by a consumer/non-health professional from United States on 2012-08-13

Patient: 41 year old male, weighing 83.9 kg (184.6 pounds)

Reactions: Flat Affect, Drug Ineffective, Schizophrenia, Paranoid Type, Loss of Libido, Feeling Abnormal

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

Zoloft
    Dosage: unk
    Indication: Agitation

Seroquel
    Dosage: unk
    Indication: Sleep Disorder

Viagra
    Dosage: unk, as needed
    Administration route: Oral
    Indication: Loss of Libido

Cialis
    Dosage: unk



Possible Levitra side effects in male

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

Patient: male

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Levitra



Possible Levitra side effects in 58 year old male

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: 58 year old male

Reactions: Deafness Unilateral, Headache

Drug(s) suspected as cause:
Levitra

Other drugs received by patient: Terazosin Hydrochloride



Possible Levitra side effects in 63 year old male

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

Patient: 63 year old male

Reactions: Erectile Dysfunction

Drug(s) suspected as cause:
Levitra

Other drugs received by patient: Levothyroxine Sodium



Possible Levitra side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-03

Patient: male

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Levitra



Possible Levitra side effects in 61 year old male

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

Patient: 61 year old male, weighing 122.5 kg (269.4 pounds)

Reactions: Small Intestinal Obstruction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Levitra

Other drugs received by patient: Vitamin D; Bupropion HCL; Drugs FOR Peptic Ulcer and Gord; Iron; Alimentary Tract and Metabolism; Antihypertensives; Mercaptopurine; Omeprazole; Asacol; Cholesterol and Triglyceride Reducers; Hydrochlorothiazide



Possible Levitra side effects in 41 year old male

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

Patient: 41 year old male, weighing 83.9 kg (184.6 pounds)

Reactions: Off Label Use, Flat Affect, Agitation, Fatigue, Libido Decreased, Intentional Drug Misuse

Drug(s) suspected as cause:
Seroquel
    Administration route: Oral
    Indication: Sleep Disorder

Viagra
    Administration route: Oral
    Indication: Loss of Libido

Levitra

Cialis

Zoloft
    Indication: Agitation



Possible Levitra side effects in 75 year old male

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

Patient: 75 year old male

Reactions: Eye Haemorrhage, Drug Ineffective

Drug(s) suspected as cause:
Levitra

Other drugs received by patient: Levitra; Desloratadine; Lipitor; Cartia XT



Possible Levitra side effects in 54 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-30

Patient: 54 year old male

Reactions: Erectile Dysfunction

Drug(s) suspected as cause:
Levitra

Other drugs received by patient: Metformin Hydrochloride; Benicar; Aspirin; Januvia; Glipizide



Possible Levitra side effects in 56 year old female

Reported by a consumer/non-health professional from United States on 2012-07-30

Patient: 56 year old female

Reactions: Pulmonary Hypertension, Lung Disorder, Therapeutic Response Unexpected

Drug(s) suspected as cause:
Levitra
    Dosage: 20 mg, qd
    Administration route: Oral
    Indication: Scleroderma
    Start date: 2010-08-01

Levitra
    Indication: Dyspnoea

Levitra
    Indication: Skin Ulcer

Levitra
    Indication: Pain

Levitra
    Indication: Ulcer

Levitra
    Indication: Fatigue

Other drugs received by patient: Nifedipine; Procardia; Maxzide; Netylin; Omeprazole



Possible Levitra side effects in male

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

Patient: male

Reactions: Visual Acuity Reduced Transiently, Retinal Vein Occlusion, Macular Degeneration

Drug(s) suspected as cause:
Levitra



Possible Levitra side effects in 66 year old male

Reported by a physician from French Polynesia on 2012-07-26

Patient: 66 year old male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Levitra

Other drugs received by patient: Plavix; Fluvastatin Sodium; Irbesartan; Allopurinol



Possible Levitra side effects in 56 year old female

Reported by a consumer/non-health professional from United States on 2012-07-26

Patient: 56 year old female

Reactions: Therapeutic Response Unexpected

Drug(s) suspected as cause:
Levitra
    Indication: Skin Ulcer

Levitra
    Indication: Pain

Levitra
    Dosage: 20 mg, qd
    Administration route: Oral
    Indication: Scleroderma
    Start date: 2010-08-01

Levitra
    Indication: Dyspnoea

Levitra
    Indication: Fatigue

Levitra
    Indication: Ulcer

Other drugs received by patient: Omeprazole; Procardia; Netylin; Maxzide; Nifedipine



Possible Levitra side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-25

Patient: male

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Levitra

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