tadalafil Side Effects
Also known as: Cialis
Analysis of 96,629 adverse event reports submitted to the FDA from 2004 to 2025.
Total Reports
96,629
Death-Related
10,913
11.3% of reports
Hospitalizations
36,455
37.7% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 10,913 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 5,856 |
| DYSPNOEA | 1,277 |
| PULMONARY ARTERIAL HYPERTENSION | 1,043 |
| DIARRHOEA | 630 |
| PNEUMONIA | 622 |
| PULMONARY HYPERTENSION | 554 |
| HEADACHE | 547 |
| CARDIAC FAILURE | 516 |
| RIGHT VENTRICULAR FAILURE | 470 |
| NAUSEA | 458 |
| RESPIRATORY FAILURE | 436 |
| FLUID RETENTION | 407 |
| HYPOTENSION | 407 |
| DISEASE PROGRESSION | 383 |
| CONDITION AGGRAVATED | 380 |
| FATIGUE | 376 |
| MALAISE | 350 |
| CARDIAC ARREST | 345 |
| OFF LABEL USE | 282 |
| FALL | 281 |
Reactions in Hospitalization Reports
Top reactions in 36,455 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| DYSPNOEA | 6,932 |
| PNEUMONIA | 3,625 |
| HEADACHE | 3,525 |
| DIARRHOEA | 3,413 |
| NAUSEA | 2,867 |
| FLUID RETENTION | 2,396 |
| FATIGUE | 2,191 |
| PULMONARY ARTERIAL HYPERTENSION | 1,970 |
| DIZZINESS | 1,968 |
| VOMITING | 1,919 |
| MALAISE | 1,887 |
| HYPOTENSION | 1,796 |
| DEATH | 1,725 |
| CHEST PAIN | 1,634 |
| COUGH | 1,534 |
| FALL | 1,518 |
| HOSPITALISATION | 1,478 |
| ASTHENIA | 1,385 |
| OXYGEN SATURATION DECREASED | 1,375 |
| PYREXIA | 1,367 |
Nearby — Related Medications
What the FAERS Data Reveals About tadalafil Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 96,629 voluntary reports linked to tadalafil and its brand equivalents (Cialis), spanning 2004 through 2025. Of those, 10,913 (11.3%) listed death as an outcome and 36,455 (37.7%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 53% were female and 47% male; age distribution skews toward 45-64, with 25,717 reports in that bracket. The single most reported reaction is dyspnoea with 11,663 submissions, followed by headache and diarrhoea.
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.
Read our methodology — how this data is sourced, computed, and verified.