Tadalafil: Side Effects, Uses & Monitoring
1.1 Erectile Dysfunction Tadalafil tablets are indicated for the treatment of erectile dysfunction (ED).
- Data source
- FDA labeling via NIH DailyMed (label 8c687cd7…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
| Adverse reaction (as reported in labeling) | Reported frequency* |
|---|---|
| Headache | 15% |
| Dyspepsia | 10% |
| Back pain | 6% |
| Gastroenteritis | 5% |
| Myalgia | 4% |
| Nasopharyngitis | 4% |
| Cough | 4% |
| Nasal congestion | 3% |
| Flushing* | 3% |
| Pain in limb | 3% |
| Upper respiratory tract infection | 3% |
| Flushing | 3% |
| Hypertension | 3% |
| Diarrhea | 2% |
| Pain in extremity | 2% |
| Urinary tract infection | 2% |
| Gastroesophageal reflux disease | 2% |
| Abdominal pain | 2% |
| Dizziness | 1% |
*Highest percentage reported for the active moiety across placebo-controlled trial tables in current FDA labeling. Values reflect trial reporting, not your individual risk.
Labeled uses (from FDA prescribing information)
1.1 Erectile Dysfunction Tadalafil tablets are indicated for the treatment of erectile dysfunction (ED). 1.2 Benign Prostatic Hyperplasia Tadalafil tablets are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). 1.3 Erectile Dysfunction and Benign Prostatic Hyperplasia Tadalafil tablets are indicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH). 1.4 Limitation of Use If tadalafil tablets are used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks because the incremental benefit of tadalafil tablets decrease from 4 weeks until 26 weeks, and the incremental benefit of tadalafil tablets beyond 26 weeks is unknown [see Clinical Studies (14.3)].
Conditions associated with Tadalafil in labeling
Frequently Asked Questions
What is Tadalafil used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Tadalafil?
The table above shows adverse reactions and the highest frequencies reported in placebo-controlled trials summarized in current FDA labeling for Tadalafil. Individual risk varies.
Does Tadalafil require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Tadalafil.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.