Tadalafil is a phosphodiesterase 5 inhibitor sold in the U.S. under 6 brand and generic names, for pulmonary hypertension and vasculogenic impotence. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Adcirca (application NDA022332). Other tadalafil products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
40 mg once daily, with or without food. ( 2.1 ) Dividing the dose (40 mg) over the course of the day is not recommended. ( 2.1 ) Use with ritonavir requires dosage adjustments. ( 2.4 ) 2.1 Pulmonary Arterial Hypertension The recommended dose of ADCIRCA is 40 mg (two 20 mg tablets) taken once daily with or without food. Dividing the dose (40 mg) over the course of the day is not recommended. 2.2 Dose Adjustment in Renal Impairment Mild (creatinine clearance 51 to 80 mL/min) or moderate (creatinine clearance 31 to 50 mL/min): Start dosing at 20 mg once daily. Increase to 40 mg once daily based on individual tolerability. Severe (creatinine clearance <30 mL/min and on hemodialysis): Avoid use of ADCIRCA because of increased tadalafil exposure (AUC), limited clinical experience, and the lack of ability to influence clearance by dialysis [see Use in Specific Populations ( 8.6 )] . 2.3 Dose Adjustment in Hepatic Impairment Mild or moderate (Child Pugh Class A or B): Because of limited clinical experience in patients with mild to moderate hepatic cirrhosis, consider a starting dose of 20 mg once per day. Severe (Child Pugh Class C): Patients with severe hepatic cirrhosis have not been studied. Avoid use of ADCIRCA [see Use in Specific Populations ( 8.7 )] . 2.4 Dose Adjustments for Use with Ritonavir Co-administration of ADCIRCA in Patients on Ritonavir In…
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 ) and Patient Counseling Information ( 17 )] 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 Eli Lilly and Company at 1-800-545 5979 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 ADCIRCA, 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 ADCIRCA 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 ADCIRCA 40 mg was 4% compared to 5% in placebo-treated patients. In the placebo-controlled study, the most common…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Prescription | Tablet | Generic | $5 | View → | |
| 2 | 46/100 | Prescription | Tablet | Generic |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| 1040;MT | 10 mg / 40 mg | white | oval | — |
| 1020;MT | 10 mg / 20 mg | pink | oval | — |
| FJ1 | 2.5 mg | white | oval | — |
| 990 | 20 mg | orange | oval | — |
| 049 | 5 mg | yellow | oval | — |
| 049 | 5 mg | yellow |
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
The elimination half-life of tadalafil is about 17.5 hours. This is the elimination half-life of tadalafil itself. Its metabolites are not expected to be pharmacologically active, so none extends the drug's effect. The half-life and drug levels can be higher in older adults (about 25% higher exposure at 65+) and in people with reduced kidney or liver function.
CIALIS (tadalafil) tablet, film coated — DailyMed FDA prescribing information ↗Half-life is how long the body takes to clear half a dose. It is not the same as how long a drug test can detect it, and it varies with age, kidney and liver function.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Concomitant organic nitrates ( 4.1 ) Concomitant Guanylate Cyclase (GC) Stimulators ( 4.2 ) History of known serious hypersensitivity reaction to ADCIRCA or CIALIS ( 4.3 ) 4.1 Concomitant Organic Nitrates ADCIRCA 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 ADCIRCA. ADCIRCA potentiates the hypotensive effect of nitrates. This potentiation is thought to result from the combined effects of nitrates and ADCIRCA 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 ADCIRCA is contraindicated. ADCIRCA may potentiate the hypotensive effects of GC stimulators. 4.3 Hypersensitivity Reactions ADCIRCA is contraindicated in patients with a known serious hypersensitivity to tadalafil (ADCIRCA or CIALIS). Hypersensitivity reactions have been reported, including Stevens-Johnson syndrome and exfoliative dermatitis [see Adverse Reactions ( 6.2 )] .
Nitrates Administration of nitrates within 48 hours after the last dose of ADCIRCA is contraindicated [see Contraindications ( 4.1 )] . 7.2 Alpha-Blockers PDE5 inhibitors, including ADCIRCA, and alpha–adrenergic blocking agents are both vasodilators with blood-pressure-lowering effects. When vasodilators are used in combination, an additive effect on blood pressure may be anticipated. Clinical pharmacology studies have been conducted with coadministration of tadalafil with doxazosin, alfuzosin or tamsulosin [see Clinical Pharmacology ( 12.2 )] . 7.3 Antihypertensives PDE5 inhibitors, including ADCIRCA, are mild systemic vasodilators. Clinical pharmacology studies were conducted to assess the effect of tadalafil on the potentiation of the blood–pressure–lowering effects of selected antihypertensive medications (amlodipine, angiotensin II receptor blockers, bendroflumethiazide, enalapril, and metoprolol). Small reductions in blood pressure occurred following coadministration of tadalafil with these agents compared with placebo [see Clinical Pharmacology ( 12.2 )] . 7.4 Alcohol Both alcohol and tadalafil, a PDE5 inhibitor, act as mild vasodilators. When mild vasodilators are taken in combination, blood pressure–lowering effects of each individual compound may be increased. Substantial consumption of alcohol (e.g., 5 units or greater) in combination with ADCIRCA can increase the…
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| 3 | Not yet rated | Prescription | Tablet | Generic | $5 | View → |
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| 5 | Not yet rated | Prescription | Tablet | Generic | $5 | View → |
| 6 | Not yet rated | Prescription | Suspension | Generic | $5 | View → |
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| C;5 | 5 mg | yellow | oval | — |
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| C;10 | 10 mg | yellow | oval | — |
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| C;20 | 20 mg | yellow | oval | — |
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