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Cialis (Tadalafil) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Cialis (Tadalafil) 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 (407)
Death (20)
Life Threatening Events (7)
Disability (18)

Reports by Reaction Type

Drug Ineffective (58)Vision Blurred (41)Headache (28)Visual Impairment (24)Intentional Drug Misuse (23)Myalgia (18)Back Pain (18)Wrong Technique in Drug Usage Process (17)Nausea (14)Blindness (14)Prostate Cancer (13)Dizziness (12)

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

Possible Cialis side effects in male

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

Patient: male, weighing 82.1 kg (180.6 pounds)

Reactions: Chest Pain, Visual Impairment, Drug Hypersensitivity, Urinary Retention

Drug(s) suspected as cause:
Cialis

Other drugs received by patient: Caverject; Viagra; Triazolam



Possible Cialis side effects in male

Reported by a physician from Canada on 2012-08-24

Patient: male

Reactions: Retinal Detachment

Drug(s) suspected as cause:
Cialis



Possible Cialis side effects in 55 year old male

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: 55 year old male, weighing 130.6 kg (287.3 pounds)

Reactions: Back Pain, Bile Duct Stone, Drug Ineffective, Biliary Tract Infection, Cardiac Disorder, Abdominal Pain Upper, Malaise, Staphylococcal Infection, Vision Blurred

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cialis
    Dosage: unk
    Indication: Erectile Dysfunction

Viagra
    Dosage: 100 mg, as needed
    Administration route: Oral
    Start date: 2010-11-01

Viagra
    Dosage: 100 mg, as needed
    Administration route: Oral
    Indication: Erectile Dysfunction
    Start date: 2010-04-28

Other drugs received by patient: Plavix; Crestor; Micardis; Micardis; Plavix; Bystolic; Metoprolol; Zantac; Aspirin



Possible Cialis side effects in 70 year old male

Reported by a health professional (non-physician/pharmacist) from Israel on 2012-08-23

Patient: 70 year old male

Reactions: Muscle Contractions Involuntary

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cialis
    Dosage: 5 mg, unk
    Administration route: Oral

Cialis
    Dosage: 10 mg, unk



Possible Cialis side effects in 54 year old male

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: 54 year old male

Reactions: Drug Ineffective, Gastrointestinal Carcinoma

Drug(s) suspected as cause:
Cialis



Possible Cialis side effects in 55 year old male

Reported by a consumer/non-health professional from Ireland on 2012-08-22

Patient: 55 year old male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Cialis



Possible Cialis side effects in male

Reported by a physician from Canada on 2012-08-22

Patient: male

Reactions: Angioedema

Drug(s) suspected as cause:
Cialis

Other drugs received by patient: Crestor; Ezetimibe



Possible Cialis side effects in male

Reported by a physician from Korea, Republic of on 2012-08-22

Patient: male

Reactions: Myalgia, Nasopharyngitis, Hot Flush, Chills, Dizziness, Paralysis, Tremor

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cialis



Possible Cialis side effects in 84 year old male

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

Patient: 84 year old male

Reactions: HIP Fracture, Urinary Tract Obstruction, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cialis



Possible Cialis side effects in

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: , weighing 83.9 kg (184.6 pounds)

Reactions: Drug Ineffective, Erection Increased

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

Caverject
    Dosage: 40 ml, 1x/day
    Indication: Erectile Dysfunction
    Start date: 2008-01-01

Cialis
    Dosage: unk
    Indication: Erectile Dysfunction
    End date: 2008-01-01

Viagra
    Dosage: 100 mg, unk
    Indication: Erectile Dysfunction
    End date: 2008-01-01

Other drugs received by patient: Norvasc; Vasotec



Possible Cialis side effects in 41 year old male

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: 41 year old male, weighing 86.2 kg (189.6 pounds)

Reactions: Tinnitus

Drug(s) suspected as cause:
Cialis



Possible Cialis 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:
Cialis
    Dosage: unk

Levitra
    Dosage: unk

Seroquel
    Indication: Schizophrenia

Seroquel
    Dosage: unk
    Indication: Sleep Disorder

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

Zoloft
    Dosage: unk
    Indication: Agitation



Possible Cialis side effects in 55 year old male

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: 55 year old male, weighing 130.6 kg (287.3 pounds)

Reactions: Back Pain, Bile Duct Stone, Drug Ineffective, Biliary Tract Infection, Cardiac Disorder, Abdominal Pain Upper, Malaise, Staphylococcal Infection, Vision Blurred

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cialis
    Dosage: unk
    Indication: Erectile Dysfunction

Viagra
    Dosage: 100 mg, as needed
    Administration route: Oral
    Start date: 2010-11-01

Viagra
    Dosage: 100 mg, as needed
    Administration route: Oral
    Indication: Erectile Dysfunction
    Start date: 2010-04-28

Other drugs received by patient: Aspirin; Micardis; Zantac; Plavix; Crestor; Plavix; Micardis; Bystolic; Metoprolol



Possible Cialis side effects in 80 year old male

Reported by a consumer/non-health professional from United Kingdom on 2012-08-17

Patient: 80 year old male

Reactions: HIP Arthroplasty, Post Procedural Complication, Incorrect Product Storage

Drug(s) suspected as cause:
Cialis



Possible Cialis side effects in 48 year old male

Reported by a consumer/non-health professional from France on 2012-08-16

Patient: 48 year old male

Reactions: Drug Ineffective, Vision Blurred, Dizziness, Headache

Drug(s) suspected as cause:
Cialis



Possible Cialis side effects in 62 year old male

Reported by a individual with unspecified qualification from United States on 2012-08-16

Patient: 62 year old male, weighing 72.6 kg (159.7 pounds)

Reactions: Drug Ineffective, Erectile Dysfunction

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Cialis
    Dosage: 5mg 1 or two week po 10mg once per week max po
    Administration route: Oral
    Indication: Erectile Dysfunction
    Start date: 2008-12-15
    End date: 2012-08-01

Cialis
    Dosage: 5mg 1 or two week po 10mg once per week max po
    Administration route: Oral
    Indication: Erectile Dysfunction
    Start date: 2012-04-10
    End date: 2012-08-03



Possible Cialis side effects in 45 year old male

Reported by a physician from Japan on 2012-08-16

Patient: 45 year old male

Reactions: Thrombosis, Cardiac Failure, Cerebral Infarction, Counterfeit Drug Administered, Pulmonary Oedema, Hypertension, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cialis



Possible Cialis side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-16

Patient: male

Reactions: Vascular Graft, Drug Ineffective

Drug(s) suspected as cause:
Cialis
    Dosage: 2.5 mg, unk
    Indication: Erectile Dysfunction
    Start date: 2010-06-01

Cialis
    Dosage: 5 mg, unk



Possible Cialis side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-16

Patient: male

Reactions: Neoplasm Malignant

Drug(s) suspected as cause:
Cialis



Possible Cialis side effects in male

Reported by a consumer/non-health professional from United Kingdom on 2012-08-15

Patient: male

Reactions: Cardiac Failure

Drug(s) suspected as cause:
Cialis
    Dosage: 1 df, prn

Cialis
    Dosage: 5 mg, qd



Possible Cialis side effects in 59 year old male

Reported by a consumer/non-health professional from United Kingdom on 2012-08-15

Patient: 59 year old male, weighing 84.0 kg (184.8 pounds)

Reactions: Angioedema, Nausea, Anaphylactic Shock, Headache

Drug(s) suspected as cause:
Cialis

Other drugs received by patient: ACE Inhibitors; Omeprazole; Mirtazapine



Possible Cialis side effects in female

Reported by a physician from United States on 2012-08-14

Patient: female

Reactions: Congestive Cardiomyopathy, Intentional Drug Misuse, Arrhythmia

Adverse event resulted in: death

Drug(s) suspected as cause:
Cialis

Other drugs received by patient: Hydrocodone Bitartrate; Acetaminophen



Possible Cialis side effects in male

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

Patient: male

Reactions: Retinal Artery Embolism, Blindness

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Cialis



Possible Cialis side effects in 55 year old male

Reported by a physician from Japan on 2012-08-14

Patient: 55 year old male

Reactions: Product Counterfeit, Interstitial Lung Disease

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Cialis

Other drugs received by patient: Antihypertensives; Antibiotics



Possible Cialis side effects in 60 year old male

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

Patient: 60 year old male, weighing 99.8 kg (219.5 pounds)

Reactions: Product Counterfeit, Burning Sensation, Gastrointestinal Haemorrhage, Malaise, Vomiting, Metal Poisoning, Gastrooesophageal Reflux Disease, Gastritis

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

Bismuth Subsalicylate
    Dosage: unk
    Indication: Gastrooesophageal Reflux Disease

Bismuth Subsalicylate
    Indication: Gastritis

Cialis
    Dosage: unk
    Indication: Erectile Dysfunction
    End date: 2012-06-24

Viagra
    Dosage: 50 mg, as needed
    Administration route: Oral
    Indication: Erectile Dysfunction
    End date: 2012-06-24



Possible Cialis side effects in 77 year old female

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

Patient: 77 year old female

Reactions: Dyspnoea, Oedema, Intentional Drug Misuse

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cialis

Other drugs received by patient: Remodulin



Possible Cialis 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:
Cialis
    Dosage: unk

Levitra
    Dosage: unk

Seroquel
    Dosage: unk
    Indication: Sleep Disorder

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

Zoloft
    Dosage: unk
    Indication: Agitation



Possible Cialis side effects in 44 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-10

Patient: 44 year old male, weighing 82.1 kg (180.6 pounds)

Reactions: Surgery, Chest Pain, Drug Hypersensitivity, Visual Impairment, Urinary Retention

Drug(s) suspected as cause:
Caverject
    Dosage: 20 ug, every other day
    Indication: Erectile Dysfunction
    Start date: 2011-10-01

Cialis
    Dosage: unk
    Administration route: Oral
    Indication: Erectile Dysfunction

Viagra
    Dosage: unk
    Administration route: Oral
    Indication: Erectile Dysfunction

Other drugs received by patient: Triazolam



Possible Cialis side effects in male

Reported by a consumer/non-health professional from Belgium on 2012-08-10

Patient: male

Reactions: Myalgia, Muscle Contractions Involuntary

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cialis



Possible Cialis side effects in male

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

Patient: male, weighing 74.8 kg (164.6 pounds)

Reactions: Confusional State, Back Pain, Eye Irritation, Urinary Incontinence, Visual Impairment, Pyrexia, Lacrimation Increased, Asthenia

Drug(s) suspected as cause:
Cialis
    Dosage: 10 mg, prn
    Indication: Erectile Dysfunction
    Start date: 2012-06-24
    End date: 2012-06-24

Cialis
    Dosage: 20 mg, prn

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