Prescription medication · PDE5 Inhibitor
tadalafil
Also sold as Cialis. This medicine can help men who have trouble getting or keeping an erection (ED).
Data updated 2026-05-15
- 96,629
- FDA reportsOften reported
- 25
- InteractionsSeveral interactions
- 99% less
- Generic vs brandHuge savings
- 2
- Recall records
What the data shows
tadalafil (Cialis) is a prescription PDE5 Inhibitor, more reported than most tracked drugs (96,629 FDA reports), whose generic costs a fraction of the brand (about 99% less).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
tadalafil (Cialis) is a prescription PDE5 Inhibitor. This medicine can help men who have trouble getting or keeping an erection (ED).
Tadalafil (Cialis) is a medicine that helps men with erectile dysfunction (ED) or enlarged prostate (BPH). It belongs to a class of drugs called PDE5 inhibitors.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$54.23/unit
Generic Price
$0.10/unit
Generic Savings
99%
Generic Available
Yes (31 manufacturers)
Pricing data from NADAC (CMS), effective December 25, 2024. Compare all drug costs →
NADAC price trail: TADALAFIL 5 MG TABLET
Same CMS presentation as the headline generic unit price above (5 effective dates). Adjacent % compares consecutive NADAC releases for this description only, not a patient out-of-pocket quote. Latest step: 0% vs prior release.
| Effective | NADAC / unit | vs prior | NDCs |
|---|---|---|---|
| February 21, 2024 | $0.1459/EA | - | 1 |
| June 19, 2024 | $0.1471/EA | +0.8% | 1 |
| October 23, 2024 | $0.1195/EA | -18.7% | 1 |
| December 18, 2024 | $0.1003/EA | -16.1% | 32 |
| December 25, 2024 | $0.1003/EA | 0% | 2 |
What it does
This medicine can help men who have trouble getting or keeping an erection (ED).
Common side effects
Headache, Upset stomach, Back pain
Key warnings
If you have chest pain, tell your doctor.
The sections below are summarized in plain English from tadalafil's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Tadalafil works by relaxing the muscles in the penis and prostate. This increases blood flow to these areas. For BPH, it relaxes muscles in the prostate and bladder, which can improve urinary symptoms.
Side Effects (from patient reports)
Based on 96,629 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for tadalafil, by number of reports
- Dyspnoea
Dyspnoea
11,663 reports
- Headache
Headache
10,690 reports
- Diarrhoea
Diarrhoea
7,799 reports
- Nausea
Nausea
6,498 reports
- Death
Death
5,899 reports
- Fatigue
Fatigue
5,836 reports
- Dizziness
Dizziness
5,177 reports
- Pneumonia 4,225
Pneumonia
4,225 reports
- Cough 4,199
Cough
4,199 reports
- Malaise 3,723
Malaise
3,723 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for tadalafil each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where tadalafil sits
tadalafil has more FDA adverse-event reports than 85% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is tadalafil; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 96,629 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
96,629
Reports Mentioning Death
10,913
11.3% of reports — not proof of cause
Hospitalization Reports
36,455
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DYSPNOEA | 11,663 |
| 2 | HEADACHE | 10,690 |
| 3 | DIARRHOEA | 7,799 |
| 4 | NAUSEA | 6,498 |
| 5 | DEATH | 5,899 |
| 6 | FATIGUE | 5,836 |
| 8 | DIZZINESS | 5,177 |
| 9 | PNEUMONIA | 4,225 |
| 10 | COUGH | 4,199 |
| 11 | MALAISE | 3,723 |
| 12 | VOMITING | 3,434 |
| 13 | ASTHENIA | 3,306 |
| 14 | PAIN IN EXTREMITY | 3,297 |
| 15 | PAIN | 3,291 |
| 16 | FLUID RETENTION | 3,149 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
If you have chest pain, tell your doctor. If you need nitrates for a heart problem, wait 48 hours after taking tadalafil before taking nitrates. If you get an erection that lasts more than 4 hours, get medical help right away. If you have sudden vision loss in one or both eyes, stop taking this medicine and get medical help right away. If you have a sudden decrease or loss of hearing, stop taking this medicine and get medical help right away.
Known Drug Interactions
7 DRUG INTERACTIONS 7.1 Phosphodiesterase Inhibitors BiDil is contraindicated in patients who are using a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5), PDE5 inhibitors such as avanafil, sildenafil, vardenafil, and tadalafil have been shown to potentiate the hypotensive effects of organic nitrates.
Mechanism: These medicines both lower blood pressure in a similar way, and using them at the same time can cause a severe and unsafe drop in blood pressure.
Phosphodiesterase inhibitors: Sildenafil Tadalafil Vardenafil Use With Caution Sildenafil, Tadalafil, Vardenafil: Each of these phosphodiesterase inhibitors is primarily metabolized by CYP3A, and CYP3A will be inhibited by concomitant administration of clarithromycin. Co-administration of clarithromycin with sildenafil, tadalafil, or vardenafil will result in increased exposure of these phosphodiesterase inhibitors.
Mechanism: Clarithromycin stops the body from breaking down tadalafil properly. This leads to higher levels of tadalafil in your blood, which can increase the risk of side effects.
Pulmonary hypertension agents (PDE5 inhibitors) tadalafil (Adcirca ® ) ↑ tadalafil Avoid concomitant use of tadalafil with PAXLOVID for pulmonary hypertension. sildenafil, tadalafil, vardenafil ↑ sildenafil ↑ tadalafil ↑ vardenafil Dosage adjustment is recommended for use of sildenafil, tadalafil or vardenafil with PAXLOVID when used for erectile dysfunction.
Mechanism: This combination prevents the body from clearing tadalafil, leading to much higher levels of the drug in your system.
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, bendrofluazide, enalapril, and metoprolol).
Mechanism: Both drugs lower blood pressure, so taking them together can cause an additive effect that drops blood pressure further.
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, bendrofluazide, enalapril, and metoprolol).
Mechanism: These drugs both work to lower blood pressure, which can lead to a combined effect that lowers pressure more than intended.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
Can I take this medicine with food?
How long does this medicine last?
Can I drink alcohol while taking this medicine?
What should I do if I get a headache?
Can I take this with other medications?
Is it safe to take Tadalafil every day?
Can Tadalafil cure ED or BPH?
How quickly does Tadalafil work?
Can women take Tadalafil?
Can I buy Tadalafil over the counter?
What are the common side effects of tadalafil?
Does tadalafil interact with other medications?
What drug class is tadalafil?
Is there a generic version of tadalafil?
What pregnancy or breastfeeding source fields are listed for tadalafil?
Has tadalafil been recalled?
Active Recalls
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Preferred Pharmaceuticals, Inc.
CGMP Deviations
Northwind Pharmaceuticals LLC
Related Medications in PDE5 Inhibitor
Other drugs grouped near tadalafil - same-class peers and common alternatives.
alfuzosin
Uroxatral
Alfuzosin is a medicine that helps men with enlarged prostate glands.
Compare with tadalafil →
bethanechol
Urecholine
Bethanechol helps you to urinate if you have trouble emptying your bladder.
Compare with tadalafil →
darifenacin
Enablex
Darifenacin (Enablex) is a medicine that helps control an overactive bladder.
Compare with tadalafil →
dutasteride
Avodart
Dutasteride and tamsulosin hydrochloride capsules contain two medicines to treat enlarged prostate in men.
Compare with tadalafil →
dutasteride/tamsulosin
Jalyn
This medicine combines two drugs to treat enlarged prostate in men.
Compare with tadalafil →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for tadalafil: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 96,629.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 11.29%.
- nifedipine Δ 0.01 pts · 45,410 reports · Calcium Channel Blocker 11.28%death share
- metronidazole topical Δ 0.02 pts · 45,816 reports · Topical Antibiotic (Rosacea) 11.28%death share
- pantoprazole Δ 0.04 pts · 240,800 reports · Proton Pump Inhibitor (PPI) 11.25%death share
- ferrous sulfate Δ 0.04 pts · 47,788 reports · Iron Supplement 11.34%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for tadalafil
The FDA label for tadalafil (sold under brand names such as Cialis) classifies it as a prescription-only medication in the PDE5 Inhibitor class. This medicine can help men who have trouble getting or keeping an erection (ED). Official labeling lists 7 commonly reported side effects, including Headache, Upset stomach, Back pain.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 96,629 voluntary reports. The database also lists 25 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $0.10 versus $54.23 for the brand - a 99% generic savings.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 2 recall records on file), and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: October 16, 2024
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages