This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
TADLIQ is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class II – III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%). ( 1.1 ) 1.1 Pulmonary Arterial Hypertension TADLIQ ® is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class II – III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%).
Concomitant organic nitrates ( 4.1 ) Concomitant Guanylate Cyclase (GC) Stimulators ( 4.2 ) History of known serious hypersensitivity reaction to TADLIQ, ADCIRCA ® or CIALIS ® ( 4.3 ) 4.1 Concomitant Organic Nitrates TADLIQ is contraindicated in patients who are using any form of organic nitrate, either regularly or intermittently. Do not use nitrates within 48 hours of the last dose of TADLIQ. TADLIQ potentiates the hypotensive effect of nitrates. This potentiation is thought to result from the combined effects of nitrates and TADLIQ on the nitric oxide/cGMP pathway [see Clinical Pharmacology ( 12.2 )] . 4.2 Concomitant Guanylate Cyclase (GC) Stimulators Coadministration of GC stimulators such as riociguat with TADLIQ is contraindicated. TADLIQ may potentiate the hypotensive effects of GC stimulators. 4.3 Hypersensitivity Reactions TADLIQ is contraindicated in patients with a known serious hypersensitivity to tadalafil (TADLIQ, ADCIRCA ® or CIALIS ® ). Hypersensitivity reactions have been reported, including Stevens-Johnson syndrome and exfoliative dermatitis [see Adverse Reactions ( 6.2 )] .
Hypotension: Carefully consider whether patients with certain underlying cardiovascular disease could be adversely affected by vasodilatory effects of TADLIQ. Not recommended in patients with pulmonary veno-occlusive disease. ( 5.1 , 5.2 ) Effects on the eye: Sudden loss of vision could be a sign of non-arteritic ischemic optic neuropathy (NAION) and may be permanent. ( 5.3 ) Hearing impairment: Cases of sudden decrease or loss of hearing have been reported with tadalafil. ( 5.4 ) Concomitant PDE5 inhibitors: Avoid use with CIALIS, ADCIRCA or other PDE5 inhibitors. ( 5.5 ) Prolonged erection: Advise patients to seek emergency treatment if an erection lasts >4 hours. ( 5.6 ) 5.1 Hypotension TADLIQ has vasodilatory properties that may result in transient decreases in blood pressure. Prior to prescribing TADLIQ, carefully consider whether patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects. Patients with preexisting hypotension, with autonomic dysfunction, with left ventricular outflow obstruction, may be particularly sensitive to the actions of vasodilators. 5.2 Worsening Pulmonary Vascular Occlusive Disease Pulmonary vasodilators ...
The following serious adverse reactions are discussed elsewhere in the labeling: Hypotension [see Warnings and Precautions ( 5.1 )] Visual Loss [see Warnings and Precautions ( 5.3 )] Hearing loss [see Warnings and Precautions ( 5.4 )] Priapism [see Warnings and Precautions ( 5.6 )] The most common adverse reaction is headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact CMP Development, LLC at 1-844-321-1443, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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 tadalafil, 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 placebo-controlled trial were 9% for tadalafil 40 mg and 15% for placebo. The rates of discontinuation because of AEs, other than those related ...
Source: FDA SPL label for TADLIQ (CMP Pharma, Inc.), effective 20221015. Full label on DailyMed.
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
| 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|---|
| 7,572 | 6,157 | 5,494 | 5,423 | 5,989 | 5,933 | 6,440 | 2,752 |
39,793 reports blaming this drug for every million Medicare prescriptions filled, which is 14.4× the typical drug on this site. (15,073 reports in 2024–2026, against 378,785 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
| Date | Class | Firm | Reason |
|---|---|---|---|
| 03/2023 | Class II | Preferred Pharmaceuticals, Inc. | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. |
| 03/2023 | Class II | Northwind Pharmaceuticals LLC | CGMP Deviations |
| 03/2023 | Class II | Northwind Pharmaceuticals LLC | CGMP Deviations |
| 02/2023 | Class II | Accord Healthcare, Inc. | CGMP Deviations: recalling drug products following an FDA inspection. |
| 02/2023 | Class II | Accord Healthcare, Inc. | CGMP Deviations: recalling drug products following an FDA inspection. |
| 02/2023 | Class II | Accord Healthcare, Inc. | CGMP Deviations: recalling drug products following an FDA inspection. |
| 02/2023 | Class II | Accord Healthcare, Inc. | CGMP Deviations: recalling drug products following an FDA inspection. |
| 10/2021 | Class II | SUN PHARMACEUTICAL INDUSTRIES INC | Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product. |
| 10/2021 | Class II | SUN PHARMACEUTICAL INDUSTRIES INC | Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product. |
Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
In 2024, drug companies reported $83 in payments to US physicians and hospitals tied to this drug across 5 transactions (Adcirca $83).
No pending federal MDL names this drug or its brands.
Not named in any federal pharmaceutical settlement of $100M or more on record.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
| Product | Fills | $/fill |
|---|---|---|
| Tadalafil | 365,541 | $221 |
| Cialis | 7,402 | $498 |
| Adcirca | 5,153 | $4,624 |
| Alyq | 618 | $1,107 |
| Tadliq | 71 | $2,448 |
Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.