Search for drugs:
Typing the drug name to query
TADALAFIL
DIR Classification
Classification:Ambiguous
Severity Score:1.0
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- CLINICAL PHARMACOLOGY
- Effects on Cardiac Electrophysiology
- The effect of a single 100 mg dose of tadalafil on the QT interval was evaluated at the time of peak tadalafil concentration in a randomized, double-blinded, placebo, and active (intravenous ibutilide) -controlled crossover study in 90 healthy males aged 18 to 53 years. The mean change in QTc (Fridericia QT correction) for tadalafil, relative to placebo, was 3.5 milliseconds (two-sided 90% CI=1.9, 5.1). The mean change in QTc (Individual QT correction) for tadalafil, relative to placebo, was 2.8 milliseconds (two-sided 90% CI=1.2, 4.4). A 100 mg dose of tadalafil (5 times the highest recommended dose) was chosen because this dose yields exposures covering those observed upon coadministration of tadalafil with potent CYP3A4 inhibitors or those observed in renal impairment. In this study, the mean increase in heart rate associated with a 100 mg dose of tadalafil compared to placebo was 3.1 beats per minute.
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
QT Prolongation
6
24086
Other ADRs
59332
38322255
Odds Ratio = 0.161
Drug Property Information
ATC Code(s):
- G04BE08 - tadalafil
- G04BE - Drugs used in erectile dysfunction
- G04B - "OTHER UROLOGICALS, INCL. ANTISPASMODICS"
- G04 - UROLOGICALS
- G - GENITO URINARY SYSTEM AND SEX HORMONES
- C02KX52 - tadalafil
- C02KX5 -
- C02KX - Other antihypertensives
- C02K - OTHER ANTIHYPERTENSIVES
- C02 - ANTIHYPERTENSIVES
- C - CARDIOVASCULAR SYSTEM
- G04CA54 - tadalafil
- G04CA - Alpha-adrenoreceptor antagonists
- G04C - DRUGS USED IN BENIGN PROSTATIC HYPERTROPHY
- G04 - UROLOGICALS
- G - GENITO URINARY SYSTEM AND SEX HORMONES
Active Ingredient:TADALAFIL
Active Ingredient UNII:742SXX0ICT
Drugbank ID:DB00820
PubChem Compound:110635
CTD ID:D000068581
PharmGKB:PA10333
CAS Number:171596-29-5
Dosage Form(s):tablet, film coated
Route(s) Of Administrator:oral
Daily Dose:
- 10.0 mg/day G04BE08
Chemical Structure: 
SMILE Code:
[H][C@]12CC3=C(NC4=CC=CC=C34)[C@H](N1C(=O)CN(C)C2=O)C1=CC2=C(OCO2)C=C1
[H][C@]12CC3=C(NC4=CC=CC=C34)[C@H](N1C(=O)CN(C)C2=O)C1=CC2=C(OCO2)C=C1
Reference
1: Pharmacokinetic interaction between linagliptin and tadalafil in healthy Egyptian males using a novel LC-MS method.
[Mourad Sara S,El-Kimary Eman I,Barary Magda A,Hamdy Dalia A]Bioanalysis,2019 Jul;11(14):1321-1336. PMID: 31368774
2: Drugs with potential cardiac adverse effects: Retrospective study in a large cohort of parkinsonian patients.
[Heranval A,Lefaucheur R,Fetter D,Rouillé A,Le Goff F,Maltête D]Rev Neurol (Paris),Apr-May 2016;172(4-5):318-23. PMID: 27063094
3: PDE5 inhibitors: considerations for preference and long-term adherence.
[Smith W B,McCaslin I R,Gokce A,Mandava S H,Trost L,Hellstrom W J]Int J Clin Pract,2013 Aug;67(8):768-80. PMID: 23869678
4: Cardiac safety in clinical trials of phosphodiesterase 5 inhibitors.
[Carson Culley C]Am J Cardiol,2005 Dec 26;96(12B):37M-41M. PMID: 16387565
Disclaimer:
The content of this database of QT prolongation is intended for educational and scientific research purposes only. It is not intended as a substitute for professional medical advice, diagnosis or treatment.
Any mention of commercial products is for clarification and not intended as endorsement.