Common Levitra Side Effects


The most commonly reported Levitra side effects (click to view or check a box to report):

Erectile Dysfunction (899)
Headache (338)
Flushing (154)
Dizziness (121)
Nasal Congestion (104)
Vision Blurred (101)
Erection Increased (87)
Adverse Event (67)
Visual Disturbance (60)
Nausea (60)
Visual Acuity Reduced (51)
Chest Pain (47)
Feeling Abnormal (45)
Optic Ischaemic Neuropathy (44)
Dyspnoea (40)
Deafness Unilateral (38)
Visual Field Defect (36)
Dyspepsia (35)
Loss Of Consciousness (35)
Cerebrovascular Accident (33)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Levitra Side Effects Reported to FDA



Levitra Side Effect Report#9992807
Exposure During Pregnancy, Off Label Use, Abortion Spontaneous
This is a report of a 23-year-old female patient (weight: NA) from CN, suffering from the following health symptoms/conditions: pulmonary arterial hypertension,cardiac disorder, who was treated with Levitra (dosage: 5 Mg, Bid, start time: NS), combined with:
  • Antithrombotic Agents (Unk)
and developed a serious reaction and side effect(s): Exposure During Pregnancy, Off Label Use, Abortion Spontaneous after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Levitra treatment in female patients, resulting in Exposure During Pregnancy side effect.
Levitra Side Effect Report#9925127
Malaise, Vomiting, Dizziness Postural, Headache, Vertigo, Deafness Unilateral
This report suggests a potential Levitra Malaise side effect(s) that can have serious consequences. A 51-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: erectile dysfunction and used Levitra (dosage: NA) starting NS. After starting Levitra the patient began experiencing various side effects, including: Malaise, Vomiting, Dizziness Postural, Headache, Vertigo, Deafness UnilateralAdditional drugs used concurrently: NA. Although Levitra demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Malaise, may still occur.
Levitra Side Effect Report#9909596
Diarrhoea, Blood Glucose Increased, Blood Bilirubin Increased, Aspartate Aminotransferase Increased, Red Cell Distribution Width Increased, Platelet Count Decreased
This Diarrhoea problem was reported by a consumer or non-health professional from US. A 72-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: erectile dysfunction. On NS this consumer started treatment with Levitra (dosage: Unk Unk, Qd). The following drugs were being taken at the same time:
  • Cialis (20 Mg, Unk)
  • Aciphex
  • Pepcid
When using Levitra, the patient experienced the following unwanted symptoms/side effects: Diarrhoea, Blood Glucose Increased, Blood Bilirubin Increased, Aspartate Aminotransferase Increased, Red Cell Distribution Width Increased, Platelet Count DecreasedAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Diarrhoea, may become evident only after a product is in use by the general population.
Levitra Side Effect Report#9887521
Dysphonia, Hair Growth Abnormal, Swelling, Somnolence, Hypersomnia
This Dysphonia side effect was reported by a consumer or non-health professional from US. A 61-year-old male patient (weight:NA) experienced the following symptoms/conditions: erectile dysfunction,blood testosterone decreased.The patient was prescribed Levitra (drug dosage: Unk), which was initiated on 201305. Concurrently used drugs:
  • Testosterone Gel (Unk Unk, Ow)
  • Testopel (Unk)
.After starting to take Levitra the consumer reported adverse symptoms, such as: Dysphonia, Hair Growth Abnormal, Swelling, Somnolence, HypersomniaThese side effects may potentially be related to Levitra.
Levitra Side Effect Report#9878075
Extra Dose Administered
This is a report of a 51-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Levitra (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Extra Dose Administered after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Levitra treatment in male patients, resulting in Extra Dose Administered side effect.
Levitra Side Effect Report#9859617
Asthenia, Fatigue, Hangover
This report suggests a potential Levitra Asthenia side effect(s) that can have serious consequences. A 73-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: erectile dysfunction and used Levitra (dosage: 10 Mg, Q2wk) starting NS. After starting Levitra the patient began experiencing various side effects, including: Asthenia, Fatigue, HangoverAdditional drugs used concurrently:
  • Carvedilol
  • Lisinopril
Although Levitra demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Asthenia, may still occur.
Levitra Side Effect Report#9798278
Gastrointestinal Carcinoma, Metastases To Liver
This Gastrointestinal Carcinoma problem was reported by a consumer or non-health professional from DE. A 72-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: erectile dysfunction,hypertension. On 2010 this consumer started treatment with Levitra (dosage: 5 Mg, Prn). The following drugs were being taken at the same time:
  • Aprovel (0.5 Df, Qd)
When using Levitra, the patient experienced the following unwanted symptoms/side effects: Gastrointestinal Carcinoma, Metastases To LiverAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Gastrointestinal Carcinoma, may become evident only after a product is in use by the general population.
Levitra Side Effect Report#9785608
Headache
This Headache side effect was reported by a consumer or non-health professional from US. A 44-year-old male patient (weight:NA) experienced the following symptoms/conditions: erectile dysfunction.The patient was prescribed Levitra (drug dosage: 10 Mg, Twice A Month), which was initiated on 2007. Concurrently used drugs: NA..After starting to take Levitra the consumer reported adverse symptoms, such as: HeadacheThese side effects may potentially be related to Levitra.
Levitra Side Effect Report#9785602
Vertigo, Dizziness
This is a report of a 66-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: erectile dysfunction, who was treated with Levitra (dosage: 20 Mg, Unk, start time: 201212), combined with:
  • Toprol
and developed a serious reaction and side effect(s): Vertigo, Dizziness after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Levitra treatment in male patients, resulting in Vertigo side effect.
Levitra Side Effect Report#9769030
Blood Pressure Increased, Heart Rate Increased, Headache
This report suggests a potential Levitra Blood Pressure Increased side effect(s) that can have serious consequences. A 71-year-old male patient (weight: NA) from DE was diagnosed with the following symptoms/conditions: NA and used Levitra (dosage: 10 Mg, Unk) starting
Nov 05, 2013. After starting Levitra the patient began experiencing various side effects, including: Blood Pressure Increased, Heart Rate Increased, HeadacheAdditional drugs used concurrently: NA. Although Levitra demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Blood Pressure Increased, may still occur.
Levitra Side Effect Report#9749818
Myocardial Infarction
This Myocardial Infarction problem was reported by a health professional from FR. A 66-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: erectile dysfunction. On
Nov 20, 2013 this consumer started treatment with Levitra (dosage: 20 Mg, Unk). The following drugs were being taken at the same time: NA. When using Levitra, the patient experienced the following unwanted symptoms/side effects: Myocardial InfarctionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Myocardial Infarction, may become evident only after a product is in use by the general population.
Levitra Side Effect Report#9742471
Blood Urine Present
This Blood Urine Present side effect was reported by a consumer or non-health professional from US. A 72-year-old male patient (weight:NA) experienced the following symptoms/conditions: erectile dysfunction.The patient was prescribed Levitra (drug dosage: 15 Mg, Prn), which was initiated on 2004. Concurrently used drugs:
  • Cipro
  • Glyburide
  • Metformin
  • Januvia
  • B12
  • Vitamin D
  • Garlic
  • Pravastatin
.After starting to take Levitra the consumer reported adverse symptoms, such as: Blood Urine PresentThese side effects may potentially be related to Levitra.
Levitra Side Effect Report#9732280
Haematospermia
This is a report of a 69-year-old male patient (weight: NA) from ES, suffering from the following health symptoms/conditions: NA, who was treated with Levitra (dosage: 5 Mg, Unk, start time: NS), combined with:
  • Simvastatin
and developed a serious reaction and side effect(s): Haematospermia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Levitra treatment in male patients, resulting in Haematospermia side effect.
Levitra Side Effect Report#9728365
Off Label Use
This report suggests a potential Levitra Off Label Use side effect(s) that can have serious consequences. A 59-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: prostate cancer,prostatomegaly and used Levitra (dosage: 20 Mg, Unk) starting 201310. After starting Levitra the patient began experiencing various side effects, including: Off Label UseAdditional drugs used concurrently: NA. Although Levitra demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Off Label Use, may still occur.
Levitra Side Effect Report#9726354
Muscle Spasms
This Muscle Spasms problem was reported by a consumer or non-health professional from US. A 45-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: erectile dysfunction,blood testosterone decreased. On 2009 this consumer started treatment with Levitra (dosage: Unk). The following drugs were being taken at the same time:
  • Testosterone
When using Levitra, the patient experienced the following unwanted symptoms/side effects: Muscle SpasmsAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Muscle Spasms, may become evident only after a product is in use by the general population.
Levitra Side Effect Report#9711692
Atrial Fibrillation, Tachycardia, Dizziness
This Atrial Fibrillation side effect was reported by a physician from ZA. A 65-year-old male patient (weight:NA) experienced the following symptoms/conditions: erectile dysfunction.The patient was prescribed Levitra 5 (drug dosage: 5 G, Unk), which was initiated on NS. Concurrently used drugs: NA..After starting to take Levitra 5 the consumer reported adverse symptoms, such as: Atrial Fibrillation, Tachycardia, DizzinessThese side effects may potentially be related to Levitra 5.
Levitra Side Effect Report#9711691
Reflux Gastritis
This is a report of a 57-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: erectile dysfunction, who was treated with Levitra (dosage: 20 Mg, Unk, start time: 201311), combined with: NA. and developed a serious reaction and side effect(s): Reflux Gastritis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Levitra treatment in male patients, resulting in Reflux Gastritis side effect.
Levitra Side Effect Report#9703972
Headache, Rhinorrhoea
This report suggests a potential Levitra Headache side effect(s) that can have serious consequences. A 61-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: erectile dysfunction and used Levitra (dosage: 20 Mg, Once) starting 201308. After starting Levitra the patient began experiencing various side effects, including: Headache, RhinorrhoeaAdditional drugs used concurrently: NA. Although Levitra demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Headache, may still occur.
Levitra Side Effect Report#9688475
Ventricular Tachycardia
This Ventricular Tachycardia problem was reported by a physician from DK. A 75-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: erectile dysfunction. On
Sep 06, 2013 this consumer started treatment with Levitra (dosage: 10 Mg, Unk). The following drugs were being taken at the same time:
  • Pradaxa
  • Simvastatin
  • Ramipril
When using Levitra, the patient experienced the following unwanted symptoms/side effects: Ventricular TachycardiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Ventricular Tachycardia, may become evident only after a product is in use by the general population.
Levitra Side Effect Report#9675006
Aggression, Homicide
This Aggression side effect was reported by a physician from DE. A 47-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Levitra (drug dosage: 10 Mg, Unk), which was initiated on 201005. Concurrently used drugs: NA..After starting to take Levitra the consumer reported adverse symptoms, such as: Aggression, HomicideThese side effects may potentially be related to Levitra.
Levitra Side Effect Report#9648544
Cardiovascular Disorder, Suspected Counterfeit Product
This is a report of a 74-year-old male patient (weight: NA) from DE, suffering from the following health symptoms/conditions: NA, who was treated with Levitra (dosage: 20 Mg, Prn, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Cardiovascular Disorder, Suspected Counterfeit Product after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Levitra treatment in male patients, resulting in Cardiovascular Disorder side effect.
Levitra Side Effect Report#9637581
Muscle Spasms
This report suggests a potential Levitra 10 Mg Film-coated Tablets Muscle Spasms side effect(s) that can have serious consequences. A male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: erectile dysfunction and used Levitra 10 Mg Film-coated Tablets (dosage: NA) starting NS. After starting Levitra 10 Mg Film-coated Tablets the patient began experiencing various side effects, including: Muscle SpasmsAdditional drugs used concurrently: NA. Although Levitra 10 Mg Film-coated Tablets demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Muscle Spasms, may still occur.
Levitra Side Effect Report#9637463
Choroidal Detachment
This Choroidal Detachment problem was reported by a physician from JP. A 58-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: erectile dysfunction. On 201105 this consumer started treatment with Levitra (dosage: Unk). The following drugs were being taken at the same time: NA. When using Levitra, the patient experienced the following unwanted symptoms/side effects: Choroidal DetachmentAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Choroidal Detachment, may become evident only after a product is in use by the general population.
Levitra Side Effect Report#9633355
Cerebral Haemorrhage
This Cerebral Haemorrhage side effect was reported by a health professional from FR. A 67-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Levitra (drug dosage: 1 Df, Qd), which was initiated on
Jul 29, 2013. Concurrently used drugs: NA..After starting to take Levitra the consumer reported adverse symptoms, such as: Cerebral HaemorrhageThese side effects may potentially be related to Levitra.
Levitra Side Effect Report#9628693
Nasal Discomfort, Headache, Feeling Hot, Erythema
This is a report of a 50-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: erectile dysfunction, who was treated with Levitra (dosage: 10 Mg, Once, start time:
Oct 15, 2013), combined with:
  • Omeprazole
and developed a serious reaction and side effect(s): Nasal Discomfort, Headache, Feeling Hot, Erythema after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Levitra treatment in male patients, resulting in Nasal Discomfort side effect.


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The appearance of Levitra on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

What are common Levitra Side Effects for Women?

Women Side Effects Reports
Anxiety 2
Chest Pain 2
Crying 2
Hypertension 2
Libido Increased 2
Abortion Spontaneous 1
Accidental Exposure 1
Alcohol Use 1
Amniocentesis Abnormal 1
Anencephaly 1

What are common Levitra Side Effects for Men?

Men Side Effects Reports
Erectile Dysfunction 895
Headache 338
Flushing 154
Dizziness 120
Nasal Congestion 104
Vision Blurred 101
Erection Increased 87
Adverse Event 67
Nausea 60
Visual Disturbance 60

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Levitra reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    Levitra Safety Alerts, Active Ingredients, Usage Information

    NDC 0173-0828
    Type HUMAN PRESCRIPTION DRUG
    Proprietary Name Levitra
    Name vardenafil hydrochloride
    Dosage Form TABLET, FILM COATED
    Route ORAL
    On market since 20030825
    Labeler GlaxoSmithKline LLC
    Active Ingredient(s) VARDENAFIL HYDROCHLORIDE TRIHYDRATE
    Strength(s) 2.5
    Unit(s) mg/1
    Pharma Class Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]

    Levitra Dosage, Warnings, Usage.

    Side Effects reported to FDA: 2507

    Levitra safety alerts: 2007 2005

    Reported deaths: 66

    Reported hospitalizations: 205

    Levitra (vardenafil)

    Audience: Urologists, other healthcare professionals, consumers

    [Posted 10/18/2007] FDA informed healthcare professionals of reports of sudden decreases or loss of hearing following the use of PDE5 inhibitors Viagra, Levitra, Cialis for the treatment of erectile dysfunction, and Revatio for the treatment of pulmonary arterial hypertension. In some cases, the sudden hearing loss was accompanied by tinnitus and dizziness. Medical follow-up on these reports was often limited which makes it difficult to determine if the loss of hearing was related to the use of one of the drugs, an underlying medical condition or other risk factors for hearing loss, a combination of these factors or other factors. The PRECAUTIONS and ADVERSE REACTIONS sections of the approved product labeling for Viagra, Levitra, and Cialis were revised. FDA is working with the manufacturer to revise the labeling for Revatio.

    [October 18, 2007 - Viagra Information page - FDA]
    [October 18, 2007 - Viagra label - Pfizer]
    [October 18, 2007 - Cialis Information page - FDA]
    [October 18, 2007 - Cialis label - FDA]
    [October 18, 2007 - Levitra Information page - FDA]
    [October 18, 2007 - Levitra label - FDA]

    Latest Levitra clinical trials