Tadalafil: Side Effects, Uses & Monitoring
Facts extracted from current FDA product labeling for Tadalafil. Educational only — not medical advice.
Reported adverse reactions
| Reaction | Highest frequency reported* |
|---|---|
| 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 across placebo-controlled trial tables summarized in current labeling.
Labeled uses
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)].
Medical disclaimer: Always consult a qualified healthcare professional about any medication.