What are the side effects of Tadalafil (phosphodiesterase type 5 inhibitor)?

From the Guidelines

Tadalafil is associated with several side effects, including headache, nasal congestion, flushing, agitation, hypotension, vision and hearing loss, and priapism, as reported in a 2015 study published in Circulation 1.

Common Side Effects

The most common side effects of Tadalafil include:

• Headache
• Nasal congestion
• Flushing
• Agitation
• Hypotension These side effects are typically mild to moderate in severity and may resolve on their own.

Less Common but Serious Side Effects

Less common but more serious side effects of Tadalafil include:

• Vision and hearing loss
• Priapism (an erection lasting longer than 4 hours)
• Nosebleeds These side effects require immediate medical attention to prevent long-term damage or complications.

Important Considerations

It is essential to note that Tadalafil can cause a dangerous drop in blood pressure when taken with nitrates or certain alpha-blockers, potentially leading to fainting, heart attack, or stroke 1. Patients should inform their healthcare provider about all medications they are taking before starting Tadalafil to avoid potentially dangerous interactions.

Dosage and Administration

The starting dose of Tadalafil is 0.5–1 mg·kg−1·d−1, with a maximum dose of 40 mg orally daily, as evaluated in children older than 3 years of age 1. However, the safety and efficacy data in children are limited, and once-daily dosing is recommended with a Class IIa, Level of Evidence B (LOE B) rating 1.

From the FDA Drug Label

The most common side effects with tadalafil tablets are: headache, indigestion, back pain, muscle aches, flushing, and stuffy or runny nose. These side effects usually go away after a few hours. Men who get back pain and muscle aches usually get it 12 to 24 hours after taking tadalafil tablets. Back pain and muscle aches usually go away within 2 days Uncommon side effects include: An erection that won’t go away (priapism). If you get an erection that lasts more than 4 hours, get medical help right away. Priapism must be treated as soon as possible or lasting damage can happen to your penis, including the inability to have erections Color vision changes, such as seeing a blue tinge (shade) to objects or having difficulty telling the difference between the colors blue and green. In rare instances, men taking PDE5 inhibitors (oral erectile dysfunction medicines, including tadalafil tablets) reported a sudden decrease or loss of vision in one or both eyes. Sudden loss or decrease in hearing, sometimes with ringing in the ears and dizziness, has been rarely reported in people taking PDE5 inhibitors, including tadalafil tablets

The side effects of Tadalafil are:

• Common side effects:
  • Headache
  • Indigestion
  • Back pain
  • Muscle aches
  • Flushing
  • Stuffy or runny nose
• Uncommon side effects:
  • Priapism (an erection that won’t go away)
  • Color vision changes
  • Sudden decrease or loss of vision
  • Sudden loss or decrease in hearing 2

From the Research

Tadalafil Side Effects

The side effects of Tadalafil, a phosphodiesterase type 5 inhibitor, have been studied in various clinical trials.

• Common side effects include:
  • Headache 3, 4
  • Dyspepsia 3, 4
  • Back pain 3
  • Upper abdominal pain 3
  • Myalgia 3
  • Facial flushing 4
  • Nasal congestion 4
• Less common side effects include:
  • Priapism (rare) 4
  • Prolonged erection (rare) 4
  • Increased QTc intervals 4
  • Hypotension if nitrates are given concurrently 4
• Tadalafil has been found to be well tolerated in various studies, with a low discontinuation rate due to adverse events 3, 5, 6

Special Considerations

• Tadalafil can interact with other medications, such as erythromycin and HIV protease inhibitors 4
• Tadalafil should not be taken with nitrates, as it can cause hypotension 4
• Tadalafil has been found to be effective and safe in patients with erectile dysfunction and benign prostatic hyperplasia 5, 7