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 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 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 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 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
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 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 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 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 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 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 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 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 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 47 year old male
Reported by a consumer/non-health professional from United States on 2012-07-25
Patient: 47 year old male
Reactions: Flushing, Swelling Face, Erythema, Feeling Abnormal
Drug(s) suspected as cause:
Levitra
Other drugs received by patient: Lisinopril; Crestor; Veral
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