Medical Editor: John P. Cunha, DO, FACOEP
Alyq (tadalafil) is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Alyq is available in generic form. Common side effects of Alyq include:
- muscle pain,
- runny or stuffy nose,
- respiratory tract infection,
- pain in extremities,
- back pain, or
The dose of Alyq is 40 mg once daily, with or without food. Alyq may interact with other PDE5 inhibitors, medications to treat high blood pressure, nitrates, ritonavir, alpha-blockers, alcohol, rifampin, ketoconazole, or itraconazole. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Alyq; it is unknown how it would affect a fetus. It is unknown if Alyq passes into breast milk. Consult your doctor before breastfeeding.
Our Alyq (tadalafil) Tablets, for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
The following serious adverse reactions are discussed elsewhere in the labeling:
- Hypotension [see WARNINGS AND PRECAUTIONS]
- Visual Loss [see WARNINGS AND PRECAUTIONS and PATIENT INFORMATION]
- Hearing loss [see WARNINGS AND PRECAUTIONS]
- Priapism [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Tadalafil was administered to 398 patients with PAH during clinical trials worldwide. In trials of ALYQ™, a total of 311 and 251 subjects have been treated for at least 182 days and 360 days, respectively. The overall rates of discontinuation because of an adverse event (AE) in the placebocontrolled trial were 9% for ALYQ™ 40 mg and 15% for placebo. The rates of discontinuation because of AEs, other than those related to worsening of PAH, in patients treated with ALYQ™ 40 mg was 4% compared to 5% in placebo-treated patients.
In the placebo-controlled study, the most common AEs were generally transient and mild to moderate in intensity. Table 1 presents treatment-emergent adverse events reported by ≥9% of patients in the ALYQ™ 40 mg group and occurring more frequently than with placebo.
Table 1: Treatment-Emergent Advers e Events Reported by ≥9% of Patients in ALYQ™ and More Frequent than Placebo by 2%
|EVENT||Placebo (%)||ALYQ™ 20
|Respiratory Tract Infection (Upper and Lower)||6||7||13|
|Pain in Extremity||2||5||11|
|Nasal Congestion (Including sinus congestion)||1||0||9|
The following adverse reactions have been identified during post-approval use of tadalafil. These events have been chosen for inclusion either because of their seriousness, reporting frequency, lack of clear alternative causation, or a combination of these factors. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or establish a causal relationship to drug exposure. The list does not include adverse events that are reported from clinical trials and that are listed elsewhere in this section.
Cardiovascular and cerebrovascular - Serious cardiovascular events, including myocardial infarction, sudden cardiac death, stroke, chest pain, palpitations, and tachycardia, have been reported postmarketing in temporal association with the use of tadalafil. Most, but not all, of these patients had preexisting cardiovascular risk factors. Many of these events were reported to occur during or shortly after sexual activity, and a few were reported to occur shortly after the use of tadalafil without sexual activity. Others were reported to have occurred hours to days after the use of tadalafil and sexual activity. It is not possible to determine whether these events are related directly to tadalafil, to sexual activity, to the patient’s underlying cardiovascular disease, to a combination of these factors, or to other factors [see WARNINGS AND PRECAUTIONS].
Body as a whole - Hypersensitivity reactions including urticaria, Stevens–Johnson syndrome, and exfoliative dermatitis
Nervous - Migraine, seizure and seizure recurrence, and transient global amnesia
Otologic - Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including tadalafil. In some of the cases, medical conditions and other factors were reported that may have also played a role in the otologic adverse events. In many cases, medical follow-up information was limited. It is not possible to determine whether these reported events are related directly to the use of tadalafil, to the patient’s underlying risk factors for hearing loss, a combination of these factors, or to other factors [see WARNINGS AND PRECAUTIONS and PATIENT INFORMATION].
Urogenital - Priapism [see WARNINGS AND PRECAUTIONS].
Read the entire FDA prescribing information for Alyq (Tadalafil Tablets)