HIGH-VOLUME · HOSP-HEAVY
tadalafil Side Effects
tadalafil (also sold as Cialis) is HIGH-VOLUME in this FAERS book #80 of 524 by FAERS report count. Signature opener: HOSP-HEAVY - 37.7% mention hospitalization (36,455 reports).
Data updated 2026-05-15
- 96,629
- FAERS reports
FAERS voluntary reports, 2004 to 2025. High volume tracks exposure and reporting culture; see methodology for de-dup rules.
tadalafil: 37.7% mention hospitalization (36,455 reports). Death stamp DEATH-HEAVY; volume band HIGH-VOLUME #80 of 524 by FAERS report count.
High-report extract for tadalafil (Cialis): 96,629 FAERS rows (2004-2025). Top named reactions: DYSPNOEA, HEADACHE, DIARRHOEA. Outcome stamps DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED. FAERS is voluntary signal detection, not incidence.
Counts from the openFDA FAERS extract (2004–2025). Stamps CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
DYSPNOEA leads 11,663 of 96,629 reports
Who reports · age peak 45-64 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 45-64 (25,717 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (10,913 reports, 11.3%). Top co-reported reactions in that subset - voluntary, not causal.
| 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 |
| FALL | 281 |
Reactions in Hospitalization Reports
Hospitalization is HEAVY (36,455, 37.7% of the book). Top reactions in those rows:
| 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 |
How to read tadalafil FAERS figures (CASELOAD · DEATH-HEAVY · HOSP-HEAVY)
FAERS holds 96,629 voluntary reports linked to tadalafil (Cialis), 2004-2025. Death is listed on 10,913 (11.3%). Hospitalization appears on 36,455 (37.7%). Top co-reported indication: Product Used For Unknown Indication.
CASELOAD books overweight common drugs and loud reporting cultures; HOSP-HEAVY is the page opener, not a per-patient risk.
Read with tadalafil
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-HEAVY · HOSP-HEAVY stamps.
ABS(total_reports) peer at 95,293 FAERS cases (Δ 1,336 lighter vs tadalafil); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 98,033 FAERS cases (Δ 1,404 heavier vs tadalafil); DEATH-HEAVY · HOSP-HEAVY · FEMALE-LED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 98,899 FAERS cases (Δ 2,270 heavier vs tadalafil); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 91,655 FAERS cases (Δ 4,974 lighter vs tadalafil); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 50.8 pp vs tadalafil's DEATH-HEAVY): CASELOAD · HOSP-MID.
tadalafil stamps DEATH-HEAVY · HOSP-HEAVY; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload CASELOAD and the label guide.