Drug Safety Information for CIALIS (Tadalafil)

Safety-related Labeling Changes for CIALIS (TADALAFIL) Rx Drug: FDA Link

Safety-related Labeling Changes for ADCIRCA (TADALAFIL) Rx Drug: FDA Link

Adverse Drug Reactions for CIALIS* (Tadalafil)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with CIALIS
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Dyspnoea2074
2Headache*1808
3Drug ineffective1758
4Death1260
5Dizziness1009
6Nausea886
7Fatigue869
8Pneumonia834
9Back pain*792
10Diarrhoea732
11Cough679
12Therapeutic response decreased632
13Malaise621
14Fluid retention607
15Vision blurred605
16Hypotension528
17Pain in extremity*528
18Chest pain512
19Pulmonary arterial hypertension511
20Vomiting508

* This side effect also appears in "Top 10 Side Effects of CIALIS " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking CIALIS
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Erectile dysfunction*10589
2Product used for unknown indication10094
3Pulmonary arterial hypertension1920
4Pulmonary hypertension*1264
5Benign prostatic hyperplasia*554
6Ill-defined disorder161
7Sexual dysfunction154
8Prostatectomy*78
9Cor pulmonale chronic69
10Libido decreased61

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for CIALIS

Total Reports Filed with FDA: 66348


Number of FDA Adverse Event Reports by Patient Age for CIALIS

Total Reports Filed with FDA: 66348*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Tadalafil (Adcirca, Cialis)

Charts are based on 66348 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and CIALIS Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.