Cialis (tadalafil) adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Cialis
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Brand name
Generic name: Tadalafil
Class: Phosphodiesterase 5 inhibitor

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From January 2004 to June 2026, FDA received 15,166 adverse event reports that name Cialis. In these reports the drug is a suspect or interacting product.

In the same period, 8,023 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 81 reports in the 12 months to June 2026 and 96 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 81 (under 0.1%) name Cialis. Reports for male patients were 95.2% of the reports that name Cialis and 34.6% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Cialis is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 14 reports that name Cialis.
In January to March 2026, FDA received 17.
In April to June 2025, FDA received 28.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 518 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for all 15,166 reports.

The site keeps a term for a year only if two or more reports of that year record it.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 518 terms.

Reaction terms in the reports that name Cialis, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 15,166 reports
Drug ineffectivethe medicine did not work as expected	3,413	22.5%
Headachehead pain	1,202	7.9%
Hypertensionhigh blood pressure	939	6.2%
Back pain	922	6.1%
Blood cholesterol increasedraised cholesterol	796	5.2%
Astheniaweakness or lack of energy	777	5.1%
Therapeutic response decreasedthe medicine worked less well	731	4.8%
Malignant melanomamelanoma, a skin cancer	706	4.7%
Blood testosterone decreased	621	4.1%
Vision blurredblurred vision	588	3.9%
Benign prostatic hyperplasia	555	3.7%
Wrong technique in product usage processthe product was used in the wrong way	501	3.3%
Depressionlow mood	479	3.2%
Diabetes mellitusdiabetes	446	2.9%
Erectile dysfunctiondifficulty getting or keeping an erection	440	2.9%
Intentional product misusedeliberate use not as intended	418	2.8%
Myalgiamuscle pain	407	2.7%
Flushingsudden reddening or warmth of the skin	394	2.6%
Dizzinesslight-headedness or unsteadiness	384	2.5%
Pain in extremitypain in an arm or leg	356	2.3%
Off label useused for a purpose or in a way not on the label	326	2.1%
Cardiac disorder	316	2.1%
Depressed moodlow mood	309	2%
Inappropriate schedule of drug administrationthe medicine was taken at the wrong times	307	2%
Libido decreasedreduced sex drive	304	2%
Libido disorder	297	2%
Muscle spasmsmuscle cramps	284	1.9%
Dyspepsiaindigestion	268	1.8%
Nasal congestiona blocked nose	266	1.8%
Sleep disordera sleep problem	258	1.7%
Malignant melanoma in situ	250	1.6%
Visual impairmentreduced vision	240	1.6%
Drug interactionan interaction between medicines	222	1.5%
Feeling abnormalfeeling odd or not right	213	1.4%
Dyspnoeashortness of breath	209	1.4%
Body height decreased	192	1.3%
Gastrooesophageal reflux diseaseacid reflux	189	1.2%
Insomniadifficulty sleeping	189	1.2%
Anxiety	182	1.2%
Nauseafeeling sick	180	1.2%
Somnolencedrowsiness	177	1.2%
Fatiguetiredness	176	1.2%
Painpain, site not specified	170	1.1%
Atrial fibrillationan irregular heart rhythm	166	1.1%
Tinnitusringing in the ears	165	1.1%
Hypotensionlow blood pressure	163	1.1%
Prostate cancer	155	1%
Myocardial infarctionheart attack	154	1%
Arthralgiajoint pain	150	1%
Suspected counterfeit product	149	1%

Download all 518 terms of Cialis (CSV)

The counts add to more than 15,166 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Tadalafil with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Tadalafil	Generic name	10,660
Adcirca	Brand name	12,214
Cialis (this page)	Brand name	15,166

Sum of the separately reported names: 38,040. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Cialis, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	1,379	164	17	12	75	12	0	87	1,215
2005	1,110	174	13	8	66	26	0	104	936
2006	759	192	19	5	58	14	0	136	567
2007	219	140	11	2	36	15	0	94	79
2008	294	215	24	12	50	12	0	149	79
2009	316	212	10	8	48	18	0	157	104
2010	360	255	16	9	47	14	0	219	105
2011	328	234	11	8	53	22	1	196	94
2012	353	295	15	5	78	12	0	253	58
2013	322	240	12	5	54	13	0	205	82
2014	487	221	14	11	51	15	0	165	266
2015	5,391	650	24	18	115	48	0	529	4,741
2016	715	246	7	7	57	15	0	200	469
2017	524	209	3	4	54	7	0	165	315
2018	549	348	19	5	27	8	0	305	201
2019	1,002	891	78	1	76	2	0	835	111
2020	393	317	24	2	31	8	0	279	76
2021	138	68	10	2	18	4	0	47	70
2022	130	70	4	2	7	3	0	57	60
2023	131	95	34	2	30	3	0	64	36
2024	109	70	22	0	31	0	0	41	39
2025	109	51	6	3	9	1	0	40	58
2026	48	37	0	2	7	1	0	31	11

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Cialis, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Cialis, by the year in which FDA received them
Year	Reports
2004	1,107
2005	1,226
2006	903
2007	217
2008	262
2009	340
2010	377
2011	346
2012	379
2013	312
2014	490
2015	5,435
2016	837
2017	688
2018	735
2019	593
2020	268
2021	135
2022	159
2023	130
2024	100
2025	96
2026	31

Reports that name Cialis, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Cialis
Age	Reports	Share
Under 2	5	under 0.1%
2 to 11	14	0.1%
12 to 17	14	0.1%
18 to 44	868	5.7%
45 to 64	4,771	31.5%
65 to 74	1,993	13.1%
75 and over	862	5.7%
Age not given	6,639	43.8%

Sex of the patient in the reports that name Cialis
Sex	Reports	Share
Female	197	1.3%
Male	14,440	95.2%
Unknown or not given	529	3.5%

Type of reporter in the reports that name Cialis
Reporter	Reports	Share
Physician	1,995	13.2%
Pharmacist	234	1.5%
Other health professional	420	2.8%
Lawyer	881	5.8%
Consumer or non-health professional	10,034	66.2%
Not given	1,602	10.6%

Age and sex are as the report gives them. The reporter is the primary source in the report. 71.7% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Cialis record
Indication as recorded (MedDRA)	Reports	Share
Erectile dysfunction	7,808	51.5%
Benign prostatic hyperplasia	565	3.7%
Sexual dysfunction	51	0.3%
Prostatectomy	30	0.2%
Pulmonary hypertension	27	0.2%
Ill-defined disorder	26	0.2%

The reporter fills in the indication, and the field is often empty. Each share is of all 15,166 reports.

Drugs in the same reports

Other drugs that the reports of Cialis name, in any role, in order of name
Drug	Reports that name the two
Aspirin	530
Atenolol	152
Atorvastatin	160
Crestor	209
Flomax	173
Lipitor	309
Lisinopril	442
Metformin	255
Simvastatin	189
Viagra	1,725

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pages near this one

Tadalafil same ingredient
Adcirca same ingredient
Revatio same class
Sildenafil same class
Sildenafil citrate same class
Chorionic gonadotropin next in the A to Z list
Cibinqo next in the A to Z list
Choriogonadotropin alfa next in the A to Z list
Ciclesonide next in the A to Z list
Chop next in the A to Z list
Ciclopirox next in the A to Z list
Cholestyramine for Oral Suspension Usp next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for CialisThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Cialis: adverse event reports that FDA received. https://reportedreactions.com/drug/cialis/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Cialis as a suspect or interacting product. The 8,023 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Cialis was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Cialis?

No. It is a count of what people reported to FDA: 15,166 reports from January 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Consumer or non-health professional (66.2%), physician (13.2%) and lawyer (5.8%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

To the top of the page