Never combine tadalafil with nitrates or riociguat.
These combinations can produce dangerous hypotension. Tell emergency clinicians when tadalafil was last taken; do not self-administer nitrate chest-pain treatment after tadalafil. An erection lasting more than 4 hours, sudden vision loss or sudden hearing loss needs urgent medical attention.
Warnings and precautionsIndications
ED/BPH and PAH have different labeled products and regimens.
Labeled indications by product
Cialis treats adult male ED, BPH signs/symptoms, or both. When used with finasteride to initiate BPH treatment, the Cialis contribution is recommended for up to 26 weeks because benefit beyond that is unknown. Adcirca and Tadliq treat WHO group 1 PAH to improve exercise ability; label evidence primarily involved functional class II–III idiopathic/heritable or connective-tissue-associated PAH. These labels do not authorize routine use for every form of pulmonary hypertension.
Clinical role and limitations
ED benefit needs sexual stimulation and is not contraception or STI protection. Cialis BPH evaluation must consider other urinary causes and coexisting prostate cancer. PAH therapy requires a specialist treatment plan; this profile does not supply a complete PAH combination-treatment algorithm or an off-label pediatric regimen. Do not combine tadalafil brands or other PDE5 inhibitors.
Dosage and administration
Select indication before choosing the dose, schedule and organ limits.
Adult oral regimens · Product-specific labels
Selected products can be taken with or without food. Lower limits apply with organ impairment or interactions.
| Product / indication | Regimen |
|---|---|
| ED · as needed | Start 10 mg before anticipated activity; adjust to 5 or 20 mg by response/tolerability. Maximum once/day in most patients. Cialis counseling specifies at least 30 minutes beforehand; benefit can persist up to 36 hours, not a continuous erection. |
| ED · once daily | Start 2.5 mg at approximately the same time daily; may increase to 5 mg. Current Cialis supplied strengths omit 2.5 mg; the reviewed Amneal generic supplies it. |
| BPH or ED/BPH · daily | 5 mg at approximately the same time daily. With finasteride for initial BPH treatment, up to 26 weeks. |
| Adcirca · PAH | 40 mg once daily (two 20 mg tablets); do not divide the daily dose. |
| Tadliq 20 mg/5 mL · PAH | 40 mg (10 mL) once daily. Shake well for 30 seconds before measuring; verify mg and mL with an accurate oral measuring device. |
Renal dosing · Keep indication-specific limits
| Regimen / renal function | Label instruction |
|---|---|
| ED as needed · CrCl 30–50 mL/min | Start 5 mg no more than once/day; maximum 10 mg once every 48 hours. |
| ED as needed · CrCl < 30 or hemodialysis | Maximum 5 mg once every 72 hours. |
| Daily ED · CrCl < 30 or hemodialysis | Not recommended. No fixed reduction is specified for daily ED at CrCl ≥ 30. |
| Daily BPH or ED/BPH · CrCl 30–50 | Start 2.5 mg; may increase to 5 mg by response. At CrCl < 30 or hemodialysis, not recommended. |
| PAH · CrCl 31–80 | Start 20 mg daily (Tadliq 5 mL); increase to 40 mg (10 mL) by tolerance. |
| PAH · severe renal impairment | Avoid at CrCl < 30 or with hemodialysis. The PAH labels do not assign a dose specifically for a rounded CrCl of exactly 30; obtain specialist interpretation instead of inventing a boundary. |
Hepatic dosing
ED as needed with Child-Pugh A/B: do not exceed 10 mg once/day; caution because repeated daily exposure is less studied. Daily ED/BPH with A/B: limited evidence, use caution; Child-Pugh C: Cialis not recommended. PAH with A/B cirrhosis: consider starting 20 mg daily (Tadliq 5 mL); with C, avoid. Assess interacting-drug limits separately; these are not interchangeable organ algorithms.
CYP3A4 inhibitors and ritonavir · Distinct regimens
ED/BPH with potent CYP3A4 inhibitors such as ketoconazole or ritonavir: as-needed maximum 10 mg every 72 hours; daily maximum 2.5 mg. PAH: avoid potent inhibitors such as ketoconazole/itraconazole; ritonavir has a separate timed protocol. If ritonavir has been used for ≥ 1 week, start PAH tadalafil 20 mg daily, then increase to 40 mg by tolerance. If initiating ritonavir in a patient on PAH tadalafil, stop tadalafil ≥ 24 hours before ritonavir; avoid during initiation, then after ≥ 1 week resume 20 mg daily and increase by tolerance. Use clinician supervision; do not copy the ED ritonavir rule into PAH.
Safety
Hypotension, emergency symptoms and underlying disease require attention.
Warnings and precautions
- Assess cardiovascular risk before ED treatment; avoid when sexual activity is medically inadvisable. Cialis is not recommended in recent MI (90 days), unstable/sex-associated angina, NYHA class ≥ II HF within 6 months, uncontrolled arrhythmia/BP, hypotension < 90/50 mm Hg or stroke within 6 months; these trial-exclusion-related restrictions differ from section 4 contraindications.
- BP can fall with alpha-blockers, antihypertensives, alcohol, autonomic dysfunction or outflow obstruction. Daily ED/BPH therapy creates continuous exposure and persistent interaction potential.
- After tadalafil-associated chest pain, stop sexual activity and seek emergency help; disclose the last dose. Cialis label allows consideration of nitrates only for life-threatening need after ≥ 48 hours, with close medical/hemodynamic supervision. PAH labels prohibit nitrates within 48 hours; neither permits self-treatment.
- Erection > 4 hours needs emergency treatment, painful or not. Sickle cell disease, leukemia, myeloma or penile deformation can increase priapism risk.
- Stop tadalafil and seek urgent medical care for sudden vision or hearing loss; eye events can represent NAION. Prior NAION requires benefit/risk caution; hereditary retinal disease is poorly studied.
- PAH: use is not recommended with pulmonary veno-occlusive disease; new pulmonary edema requires assessment for PVOD. Do not combine with other PDE5 inhibitors.
- Cialis: assess bleeding disorders/active peptic ulcers carefully and rule out other urologic causes before BPH treatment.
Contraindications
Organic nitrates in any form, used regularly or intermittently; guanylate-cyclase stimulators such as riociguat; known serious hypersensitivity to tadalafil or product ingredients. Nitrates include nitroglycerin, isosorbide drugs and recreational nitrite/nitrate “poppers.” PAH labels expressly prohibit nitrates within 48 hours of the last dose. Severe organ impairment restrictions and cardiovascular cautions are additionally described in dosing/warnings rather than recast as universal section 4 contraindications.
Boxed warning status
The selected current U.S. labels have no boxed warning. Nitrate/riociguat contraindications, serious hypotension and urgent eye/hearing/priapism risks remain central to safe use.
Adverse reactions and overdose
Common ED/BPH effects include headache, dyspepsia, back pain, myalgia, congestion and flushing; PAH trials also report limb pain, nausea and respiratory symptoms. Rates differ by dose/indication and cannot be transferred between ED and PAH. Serious allergy/skin reactions, cardiovascular events, NAION and hearing loss are reported after marketing, with uncertain frequency or causality. Overdose requires urgent clinical/Poison Help assessment (U.S. 1-800-222-1222) and supportive care; dialysis removes tadalafil negligibly. PAH doses > 40 mg were not studied in the selected label.
Drug interactions
Vasodilator and CYP3A interactions change treatment decisions.
Clinically relevant interactions
| Combination | Action |
|---|---|
| Nitrates / riociguat | Contraindicated; potentially dangerous hypotension. Emergency nitrate decisions require the label’s timing and supervised monitoring. |
| Alpha-blockers | ED: be stable on alpha-blocker first and start tadalafil at lowest recommended dose; assess volume status/BP. Cialis plus alpha-blocker is not recommended for BPH under this label; discontinue BPH alpha-blocker ≥ 1 day before starting daily Cialis under clinician direction. PAH: assess additive hypotension. |
| Antihypertensives / substantial alcohol | Additive BP fall. Alcohol ≥ 5 units can increase orthostatic dizziness, tachycardia and headache; discuss avoiding substantial intake. |
| Potent CYP3A4 inhibitors | Cialis as needed ≤ 10 mg every 72 hours; daily ≤ 2.5 mg. PAH labels advise avoiding potent inhibitors such as ketoconazole/itraconazole. |
| Ritonavir | PAH has initiation/steady-state protocol in dosing section; Cialis follows its separate inhibitor limits. |
| Potent CYP3A inducers | PAH: avoid chronic potent inducers such as rifampin. Cialis: exposure/efficacy can decline; label supplies no compensatory escalation. |
| Other PDE5 inhibitors / ED medicines | Combination safety/effectiveness is unestablished; do not take Cialis with Adcirca/Tadliq or another PDE5 inhibitor. |
| Grapefruit / other CYP3A inhibitors | Can increase exposure; review the exact drug/food and regimen rather than assuming the strong-inhibitor dose algorithm applies identically to all. |
Interaction interpretation
Tadalafil is predominantly a CYP3A substrate; it is not expected to substantially inhibit or induce major CYP pathways. Selected studies did not show a clinically significant PK effect on warfarin or digoxin; this does not remove patient-specific bleeding, cardiac or polypharmacy assessment.
Use in specific populations
PAH use includes women; Cialis ED/BPH indications do not.
Pregnancy, lactation and fertility
Cialis is not indicated in females. PAH labels describe limited pregnancy case-series data without an identified major-birth-defect/miscarriage signal; this is not proof of safety. Untreated maternal PAH itself risks HF, stroke, premature delivery and maternal/fetal death; specialist benefit/risk review is essential. Human milk/infant data are absent, with animal milk transfer; discuss breastfeeding and maternal need. Some long-exposure male studies found lower sperm concentrations of uncertain clinical significance; tadalafil is not a contraceptive.
Pediatric and older-adult considerations
Cialis is not indicated below 18 and its pediatric efficacy/safety is not established. U.S. Adcirca/Tadliq labels also do not establish pediatric safety/effectiveness; no pediatric dose is provided here. No age-only dose adjustment is required in selected adult labels, but older adults may be more sensitive and need review of renal function, BP and interacting medicines.
Renal and hepatic impairment
Kidney impairment increases exposure, and dialysis does not meaningfully clear the drug. Daily ED/BPH and PAH restrictions differ from intermittent ED dosing; follow the explicit table. Hepatic evidence mainly studied 10 mg in Child-Pugh A/B and is limited for higher/chronic exposure. Avoid or do not recommend severe impairment as the respective labels specify; combine organ and interaction assessments rather than applying one universal reduction.
Clinical pharmacology
PDE5 inhibition sustains cGMP-mediated smooth-muscle effects.
Mechanism of action
Tadalafil inhibits PDE5-mediated cGMP breakdown. With sexual stimulation, this enhances penile smooth-muscle relaxation and blood flow; without stimulation it does not itself initiate erection. In PAH, increased pulmonary vascular cGMP promotes vasodilation. PDE5 is also present in lower urinary tract tissues, but the exact BPH symptom mechanism is not established.
Pharmacokinetics
- Absorption
- Food does not meaningfully alter exposure; peak timing varies. ED label median peak ~2 hours, PAH tablet label median ~4 hours.
- Distribution / metabolism
- ~94% protein bound; predominant hepatic CYP3A metabolism, with metabolites not expected to be active at observed levels.
- Half-life
- ED label healthy-subject mean ~17.5 hours. PAH label after 40 mg: ~15 hours in healthy subjects, ~35 hours in pulmonary-hypertension patients not receiving bosentan. These are study-specific, not contradictory universal values.
- Elimination / repeated use
- Mostly metabolites in feces (~61%) and urine (~36%); steady state around 5 days. Dialysis has negligible removal.
Monitoring and counseling
Follow indication-specific benefit, BP and emerging adverse symptoms.
Monitoring parameters
Before ED therapy assess cardiovascular suitability for sex, nitrates/riociguat, BP, other vasodilators, renal/hepatic function and interacting drugs. Reassess ED response or BPH symptoms and alternate urinary causes. PAH follow-up needs specialist assessment of exercise/symptoms, disease progression, BP, tolerability and pulmonary edema/PVOD concern. New syncope, chest pain, eye/hearing changes or prolonged erection need immediate assessment; no routine plasma tadalafil concentration target is supplied.
Patient counseling information
Confirm the indication, schedule and exact product; do not add an extra ED dose to PAH treatment or a daily regimen. Avoid nitrates, poppers and riociguat and disclose the last dose during emergencies. Discuss all medicines, supplements, alcohol and organ disease before changes. ED treatment requires stimulation and gives no STI protection. Tadliq: shake 30 seconds before measuring and confirm 20 mg/5 mL; use an accurate oral device. Do not stop or alter PAH therapy without the specialist’s plan.
Product identification
Same ingredient does not mean same indication or supplied strengths.
Representative product
Cialis 5 mg: yellow almond-shaped film-coated tablet marked C 5; example 30-count bottle NDC 0002-4462-30. Appearance and supplied strengths differ among generics; use the actual label and package rather than color to identify a medicine.
Dosage forms and strengths
| Selected product | Presentation |
|---|---|
| Current Cialis supplied tablets | 5, 10 and 20 mg; label daily starting regimen still refers to 2.5 mg. |
| Reviewed Amneal ED/BPH generic | 2.5, 5, 10 and 20 mg tablets; the 2.5 mg tablet is white/off-white round, marked C1. |
| Adcirca PAH | 20 mg orange almond-shaped unscored tablet, marked 4467; bottle of 60, NDC 66302-467-60. |
| Tadliq PAH | 20 mg/5 mL (4 mg/mL) white/off-white peppermint suspension; 150 mL bottle, NDC 46287-045-15. |
| Scope | Other generic/PAH brands, compounded liquids and fixed combinations require their own labels; no automatic interchange claim is made. |
Storage and handling
Cialis and Adcirca: 25°C, permitted excursions 15–30°C. Reviewed Amneal tablets: 20–25°C, excursions 15–30°C. Tadliq: 20–25°C, excursions 15–30°C; dispense in a tight container and shake well for 30 seconds before use. Keep away from children and use the exact expiry/package instructions; the selected Tadliq label does not supply a universal post-opening discard interval.
References
Original sources for the clinical and product information.
- DailyMed / National Library of MedicineCialis · ED/BPH tablets
Full public manufacturer label and patient instructions; SPL version 52, effective 20260603. Product-specific directions reviewed October 1, 2026.
- DailyMed / National Library of MedicineAmneal tadalafil · ED/BPH tablets including 2.5 mg
Full public manufacturer label and patient instructions; SPL version 8, effective 20260415. Product-specific directions reviewed October 1, 2026.
- DailyMed / National Library of MedicineAdcirca · 20 mg PAH tablets
Full public manufacturer label and patient instructions; SPL version 34, effective 20251215. Product-specific directions reviewed October 1, 2026.
- DailyMed / National Library of MedicineTadliq · 20 mg/5 mL PAH oral suspension
Full public manufacturer label and patient instructions; SPL version 6, effective 20221015. Product-specific directions reviewed October 1, 2026.