Is Cialis manufactured by Eli Lilly?

There is no indication that the legitimate supply chain is at risk, therefore consumers can be confident that prescription medicines received through legitimate state-licensed pharmacies located in the U.S. are safe and effective. Counterfeit versions of Cialis can be identified by the following differences on the label of the bottle when compared to the authentic product.

Region	Typical Price per Tablet	Availability
United States	$15 - $30	Widely available
Europe	€12 - €25	Available via prescription
Asia	$8 - $20	Over-the-counter in some countries
Australia	AUD 20 - AUD 40	Prescription required
Online pharmacies	Varies	Check for legitimacy

lists “AUSTR81137” on the front of the bottle; does not include an NDC number on the front of the bottle, such as “NDC 0002-4462-30” for the 20 mg tablets; does not include the tablet strength in a colored box; has different patterns and colors; it has yellow and darker green designs on the front label; has misspellings; it lists, “CLALIS is a product of: Eli lilly Australia PTY Limited” on the side of the bottle; lists the manufacturer location as “112 Wharf Road, WEST RYDE, NSW 2114” on the side of the bottle; and lists “Lot: AC 066018, Exp: 01SEP17” on the side of the bottle. Consumers should not use products that match one or more of the descriptions above. If you have additional information about these products, you may contact FDA at DrugSupplyChainIntegrity@fda.hhs.gov. To date, FDA is not aware of consumer adverse events related to the use of these counterfeit versions of Cialis. Health care professionals and consumers are encouraged to report adverse events related to the use of any suspect medications to FDA’s MedWatch Adverse Event Reporting program by: Completing and submitting the report online at MedWatch Online Voluntary Reporting Form Downloading and completing the form (PDF - 1.22MB), then submitting it via fax at 1-800-FDA-0178 Consumers who buy prescription medicines online should be careful. Some websites sell medicine that may not be safe to use and may put their health at risk. Go to for more information about the risks, to learn the signs of websites that may sell counterfeit or otherwise unsafe medicines, and how to find legitimate licensed online pharmacies. FDA is committed to protecting public health by working to secure the drug supply chain against counterfeit and unapproved medications that enter the United States through fraudulent sources. Picture of authentic bottle of Eli Lilly’s Cialis 20 mg Tablets sold in the U.S.

Related topics

What Should I Avoid While Taking Cialis? Do not use other ED medicines or ED treatments while taking Cialis. Do not drink too much alcohol when taking Cialis (for example, 5 glasses of wine or 5 shots of whiskey). Drinking too much alcohol can increase your chances of getting a headache or getting dizzy, increasing your heart rate, or lowering your blood pressure. INDIANAPOLIS, Sept. 21, 2012 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in the European Union (EU), recommending approval of Cialis 5 mg for once daily use for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).

Product	Dosage	Quantity + Bonus	Price
Cialis Generic	5mg	20 Pills	41.99€ 39.99€	Buy
Cialis Generic	5mg	180 + 10 Pills	159.65€ 152.05€	Buy
Cialis Soft Tabs	20mg	60 + 4 Pills	159.37€ 151.78€	Buy
Cialis Generic	60mg	60 + 4 Pills	145.06€ 138.15€	Buy
Cialis Generic	5mg	10 Pills	29.39€ 27.99€	Buy
Cialis Original	20mg	120 + 8 Pills	497.29€ 473.61€	Buy
Cialis Professional	40mg	180 + 4 Pills	618.23€ 588.79€	Buy
Cialis Super Active	20mg	90 + 10 Pills	314.14€ 299.18€	Buy
Cialis Generic	2.5mg	20 Pills	40.73€ 38.79€	Buy
Cialis Professional	20mg	60 + 2 Pills	183.83€ 175.08€	Buy
Cialis Generic	60mg	30 + 2 Pills	85.33€ 81.27€	Buy
Cialis Generic	60mg	90 + 6 Pills	196.67€ 187.30€	Buy

The opinion is now referred for final action to the European Commission, which has the authority to approve medicines for the EU.

• Cialis prescription guidelines emphasize age and health status evaluation.
• The medication is contraindicated in men advised against sexual activity.
• Prior to Cialis, medical history should be reviewed thoroughly.
• Cialis enables more spontaneous and confidence-building intimacy.
• Treatment success is higher with proper adherence to dosing schedules.
• Patient-reported outcome measures monitor Cialis effectiveness.
• Cialis has been featured in numerous clinical practice guidelines.
• Fertility effects of Cialis have been studied but show no major risk.
• The drug is usually well tolerated across diverse populations.
• Treatment discontinuation can occur due to side effects or lack of efficacy.
• Lilly offers educational resources for healthcare professionals.
• Cialis complements lifestyle modification for ED treatment.

The Commission usually decides on CHMP recommendations within one to two months. Cialis was approved for erectile dysfunction (ED) in the EU in 2002.

• Cialis dosages allow flexibility: starting doses vary per patient need.
• Low-dose daily Cialis supports continuous readiness for sexual activity.
• Higher doses are typically used for occasional use prior to intercourse.
• Cialis clinical trials involved thousands of participants worldwide.
• Lilly’s research focused on minimizing adverse effects and maximizing efficacy.
• Cialis can alleviate symptoms of BPH by relaxing bladder muscles.
• Studies confirmed Cialis improves overall sexual satisfaction scores.
• The drug has a favorable safety profile compared to some alternatives.
• Lilly Armed Cialis with extensive marketing campaigns globally.
• Patient adherence improves if side effects are well managed.
• Cialis is contraindicated in patients with severe cardiovascular disease.
• The drug is monitored for post-marketing surveillance of safety.

Cialis for once daily use was approved for the treatment of ED in the EU in 2007. "If approved by the European Commission, Cialis will be the only medication in the EU to provide a single treatment option for men with both ED and BPH," said Anthony Beardsworth, senior medical director at Lilly. "The CHMP positive opinion for Cialis marks an important regulatory milestone for Eli Lilly and Company and our commitment to bringing new treatment options to the millions of men who experience ED and BPH." Cialis 5 mg for once daily use was approved by the U.S. Food and Drug Administration (FDA) in October 2011 for the treatment of the signs and symptoms of BPH. The FDA also approved Cialis 5 mg for once daily use to treat men who have both erectile dysfunction and the signs and symptoms of benign prostatic hyperplasia (ED+BPH). It is important to note that Cialis is not to be taken with medicines called "nitrates" such as isosorbide dinitrate or isosorbide mononitrate, which are often prescribed for chest pain, or with recreational drugs called "poppers" like amyl or butyl nitrite, as the combination may cause an unsafe drop in blood pressure. It also should not be taken by those who are allergic to Cialis or Adcirca® (tadalafil), or any of its ingredients. Anyone who experiences any symptoms of an allergic reaction, such as rash, hives, swelling of the lips, tongue or throat, or difficulty breathing or swallowing should call their healthcare provider or get help right away. In addition to the U.S., Cialis for once daily use has been approved to treat the signs and symptoms of BPH in Canada, Mexico, Brazil, South Korea, Russia, Panama, Argentina, Honduras, Ecuador, Costa Rica, Colombia and Israel. About ED and BPH ED is a condition where the penis does not fill with enough blood to harden and expand when a man is sexually excited, or when he cannot keep an erection. Approximately 50 percent of men between 40-70 years old have ED.

• Cialis is a medication used primarily to treat erectile dysfunction (ED).
• It contains the active ingredient tadalafil.
• Cialis is produced by Eli Lilly and Company.
• It works by relaxing muscles and increasing blood flow to certain areas.
• Cialis can also treat symptoms of benign prostatic hyperplasia (BPH).
• The effects of Cialis can last up to 36 hours.
• It is available in various doses, including 2.5 mg, 5 mg, 10 mg, and 20 mg.
• Cialis is taken orally, usually 30 minutes before sexual activity.
• Common side effects include headache, flushing, and indigestion.
• Cialis should not be combined with nitrates to avoid dangerous blood pressure drops.
• It was first approved by the FDA in 2003.
• Cialis can be prescribed for daily use or as needed.

BPH is a condition where the prostate enlarges, which can cause urinary symptoms. ED and BPH are conditions that may occur in the same patient. Several studies have shown that many men with ED also experience the symptoms of BPH. About Cialis Cialis is currently approved for generic brand cialis ED in more than 100 countries throughout the world. In the United States, Cialis provides men with ED two different dosing options – Cialis for once daily use (2.5 mg and 5 mg) and Cialis for use as needed (5 mg, 10 mg and 20 mg). Cialis is not to be taken more than one time each day. Cialis for once daily use is approved to treat ED, the signs and symptoms of BPH, and ED and the signs and symptoms of BPH in men who have both conditions (ED+BPH). Cialis 5 mg for once daily use is the recommended dose to treat BPH and ED+BPH.

Drug Label Information

Not studied for multiple attempts per dose. +In clinical trials, Cialis for use as needed started to work in 30 minutes for some men who took 20 mg of Cialis for use as needed. When taken as needed, Cialis was shown to improve, up to 36 hours after dosing, the ability of men with ED to have a single successful intercourse attempt. Important Safety Information for Cialis® (tadalafil) tablets What Is The Most Important Information I Should Know About Cialis? take medicines called "nitrates" such as isosorbide dinitrate or isosorbide mononitrate which are often prescribed for chest pain as the combination may cause an unsafe drop in blood pressure use recreational drugs called "poppers" like amyl nitrite and butyl nitrite are allergic to Cialis or Adcirca® (tadalafil), or any of its ingredients.

5.4 Effects on the Eye

Call your healthcare provider or get help right away if you experience any symptoms of an allergic reaction, such as rash, hives, swelling of the lips, tongue or throat, or difficulty breathing or swallowing After taking a single tablet, some of the active ingredient of Cialis remains in your body for more than 2 days. The active ingredient can remain longer if you have problems with your kidneys or liver, or you are taking certain other medications. Stop sexual activity and get medical help right away if you get symptoms such as chest pain, dizziness, or nausea during sex. Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease. What Should I Tell My Healthcare Provider Before Taking Cialis?

What should I do if I miss a dose of tadalafil?

Only your healthcare provider and you can decide if Cialis is right for you. Ask your healthcare provider if your heart is healthy enough for you to have sexual activity. You should not take Cialis if your healthcare provider has told you not to have sexual activity because of your health problems. Before taking Cialis, tell your healthcare provider about all your medical problems, particularly if you have or ever had: heart problems such as chest pain (angina), heart failure, irregular heartbeats, or have had a heart attack high or low blood pressure or have high blood pressure that is not controlled liver or kidney problems or require dialysis retinitis pigmentosa, a rare genetic (runs in families) eye disease severe vision loss, including a condition called NAION a deformed penis shape or Peyronie's disease an erection that lasted more than 4 hours blood cell problems such as sickle cell anemia, multiple myeloma, or leukemia Tell your healthcare provider about all the medicines you take especially if you take: medicines called "nitrates" which are often prescribed for chest pain alpha-blockers often prescribed for prostate problems medicines for HIV or some types of oral antifungal medications some types of antibiotics such as clarithromycin, telithromycin, erythromycin (several brand names exist, please contact your healthcare provider to determine if you are taking this medicine) other medicines or treatments for erectile dysfunction (ED) Cialis is also marketed as Adcirca for the treatment of pulmonary arterial hypertension. Do not take sildenafil citrate (Revatio®)* with Cialis. Cialis for once daily use can help men with ED be ready anytime between doses*, so they do not have to plan sexual activity around taking a pill. It can also treat the signs and symptoms of BPH. Cialis for once daily use is the only medication approved to treat both ED and the signs and symptoms of BPH. Cialis for use as needed is approved to treat erectile dysfunction (ED). Cialis for use as needed should be taken before sexual activity. It may go to work quickly (in as little as 30 minutes in some men) and can work up to 36 hours.*+ The most common side effects with Cialis are headache, indigestion, back pain, muscle aches, flushing and stuffy or runny nose. These side effects usually go away after a few hours. Men who get back pain and muscle aches usually get it 12 to 24 hours after taking Cialis. Back pain and muscle aches usually go away within two days. Not studied for multiple attempts per dose. +In clinical trials, Cialis for use as needed started to work in 30 minutes for some men who took 20 mg of Cialis for use as needed. When taken as needed, Cialis was shown to improve, up to 36 hours after dosing, the ability of men with ED to have a single successful intercourse attempt. Important Safety Information for Cialis® (tadalafil) tablets What Is The Most Important Information I Should Know About Cialis? take medicines called "nitrates" such as isosorbide dinitrate or isosorbide mononitrate which are often prescribed for chest pain as the combination may cause an unsafe drop in blood pressure use recreational drugs called "poppers" like amyl nitrite and butyl nitrite are allergic to Cialis or Adcirca® (tadalafil), or any of its ingredients. Call your healthcare provider or get help right away if you experience any symptoms of an allergic reaction, such as rash, hives, swelling of the lips, tongue or throat, or difficulty breathing or swallowing After taking a single tablet, some of the active ingredient of Cialis remains in your body for more than 2 days.

17.7 Sudden Loss of Vision

Several studies have shown that many men with ED also experience the symptoms of BPH. About Cialis Cialis is currently approved for generic brand cialis ED in more than 100 countries throughout the world. In the United States, Cialis provides men with ED two different dosing options – Cialis for once daily use (2.5 mg and 5 mg) and Cialis for use as needed (5 mg, 10 mg and 20 mg). Cialis is not to be taken more than one time each day. Cialis for once daily use is approved to treat ED, the signs and symptoms of BPH, and ED and the signs and symptoms of BPH in men who have both conditions (ED+BPH).

14.1 CIALIS for Use as Needed for ED

Cialis 5 mg for once daily use is the recommended dose to treat BPH and ED+BPH. Cialis for once daily use can help men with ED be ready anytime between doses*, so they do not have to plan sexual activity around taking a pill. It can also treat the signs and symptoms of BPH. Cialis for once daily use is the only medication approved to treat both ED and the signs and symptoms of BPH. Cialis for use as needed is approved to treat erectile dysfunction (ED).

17.1 Nitrates

Cialis for use as needed should be taken before sexual activity. It may go to work quickly (in as little as 30 minutes in some men) and can work up to 36 hours.*+ The most common side effects with Cialis are headache, indigestion, back pain, muscle aches, flushing and stuffy or runny nose. These side effects usually go away after a few hours. Men who get back pain and muscle aches usually get it 12 to 24 hours after taking Cialis. Back pain and muscle aches usually go away within two days. The active ingredient can remain longer if you have problems with your kidneys or liver, or you are taking certain other medications.

• Cialis tablets come with different packaging, including blister packs and bottles.
• Eli Lilly provides comprehensive patient information leaflets with Cialis.
• Cialis is sometimes prescribed off-label for Raynaud’s phenomenon.
• The medication has a bioavailability of about 80%.
• Food intake has minimal impact on Cialis absorption.
• Cialis is metabolized primarily by the liver enzyme CYP3A4.
• Dose adjustments might be necessary for patients with kidney impairment.
• Cialis’s half-life is approximately 17.5 hours, contributing to long effect.
• Lilly has faced generic competition for Cialis in many markets.
• The drug’s patent expiration allowed entry of tadalafil generics.
• Cialis is included in some clinical guidelines for ED management.
• Monitoring for rare but serious side effects is part of patient care.

Stop sexual activity and get medical help right away if you get symptoms such as chest pain, dizziness, or nausea during sex. Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease. What Should I Tell My Healthcare Provider Before Taking Cialis? Only your healthcare provider and you can decide if Cialis is right for you. Ask your healthcare provider if your heart is healthy enough for you to have sexual activity. You should not take Cialis if your healthcare provider has told you not to have sexual activity because of your health problems.

13.2 Animal Toxicology and/or Pharmacology

The Commission usually decides on CHMP recommendations within one to two months. Cialis was approved for erectile dysfunction (ED) in the EU in 2002. Cialis for once daily use was approved for the treatment of ED in the EU in 2007. "If approved by the European Commission, Cialis will be the only medication in the EU to provide a single treatment option for men with both ED and BPH," said Anthony Beardsworth, senior medical director at Lilly. "The CHMP positive opinion for Cialis marks an important regulatory milestone for Eli Lilly and Company and our commitment to bringing new treatment options to the millions of men who experience ED and BPH." Cialis 5 mg for once daily use was approved by the U.S.

Choose what you want

Food and Drug Administration (FDA) in October 2011 for the treatment of the signs and symptoms of BPH. The FDA also approved Cialis 5 mg for once daily use to treat men who have both erectile dysfunction and the signs and symptoms of benign prostatic hyperplasia (ED+BPH). It is important to note that Cialis is not to be taken with medicines called "nitrates" such as isosorbide dinitrate or isosorbide mononitrate, which are often prescribed for chest pain, or with recreational drugs called "poppers" like amyl or butyl nitrite, as the combination may cause an unsafe drop in blood pressure. It also should not be taken by those who are allergic to Cialis or Adcirca® (tadalafil), or any of its ingredients. Anyone who experiences any symptoms of an allergic reaction, such as rash, hives, swelling of the lips, tongue or throat, or difficulty breathing or swallowing should call their healthcare provider or get help right away.

17.10 Sexually Transmitted Disease

In addition to the U.S., Cialis for once daily use has been approved to treat the signs and symptoms of BPH in Canada, Mexico, Brazil, South Korea, Russia, Panama, Argentina, Honduras, Ecuador, Costa Rica, Colombia and Israel. About ED and BPH ED is a condition where the penis does not fill with enough blood to harden and expand when a man is sexually excited, or when he cannot keep an erection. Approximately 50 percent of men between 40-70 years old have ED. BPH is a condition where the prostate enlarges, which can cause urinary symptoms. ED and BPH are conditions that may occur in the same patient. Before taking Cialis, tell your healthcare provider about all your medical problems, particularly if you have or ever had: heart problems such as chest pain (angina), heart failure, irregular heartbeats, or have had a heart attack high or low blood pressure or have high blood pressure that is not controlled liver or kidney problems or require dialysis retinitis pigmentosa, a rare genetic (runs in families) eye disease severe vision loss, including a condition called NAION a deformed penis shape or Peyronie's disease an erection that lasted more than 4 hours blood cell problems such as sickle cell anemia, multiple myeloma, or leukemia Tell your healthcare provider about all the medicines you take especially if you take: medicines called "nitrates" which are often prescribed for chest pain alpha-blockers often prescribed for prostate problems medicines for HIV or some types of oral antifungal medications some types of antibiotics such as clarithromycin, telithromycin, erythromycin (several brand names exist, please contact your healthcare provider to determine if you are taking this medicine) other medicines or treatments for erectile dysfunction (ED) Cialis is also marketed as Adcirca for the treatment of pulmonary arterial hypertension.

5.8 Hepatic Impairment

There is no indication that the legitimate supply chain is at risk, therefore consumers can be confident that prescription medicines received through legitimate state-licensed pharmacies located in the U.S. are safe and effective. Counterfeit versions of Cialis can be identified by the following differences on the label of the bottle when compared to the authentic product. lists “AUSTR81137” on the front of the bottle; does not include an NDC number on the front of the bottle, such as “NDC 0002-4462-30” for the 20 mg tablets; does not include the tablet strength in a colored box; has different patterns and colors; it has yellow and darker green designs on the front label; has misspellings; it lists, “CLALIS is a product of: Eli lilly Australia PTY Limited” on the side of the bottle; lists the manufacturer location as “112 Wharf Road, WEST RYDE, NSW 2114” on the side of the bottle; and lists “Lot: AC 066018, Exp: 01SEP17” on the side of the bottle. Consumers should not use products that match one or more of the descriptions above.

Adverse Reactions/Side Effects

If you have additional information about these products, you may contact FDA at DrugSupplyChainIntegrity@fda.hhs.gov. To date, FDA is not aware of consumer adverse events related to the use of these counterfeit versions of Cialis. Health care professionals and consumers are encouraged to report adverse events related to the use of any suspect medications to FDA’s MedWatch Adverse Event Reporting program by: Completing and submitting the report online at MedWatch Online Voluntary Reporting Form Downloading and completing the form (PDF - 1.22MB), then submitting it via fax at 1-800-FDA-0178 Consumers who buy prescription medicines online should be careful. Some websites sell medicine that may not be safe to use and may put their health at risk. Go to for more information about the risks, to learn the signs of websites that may sell counterfeit or otherwise unsafe medicines, and how to find legitimate licensed online pharmacies.

8.3 Females and Males of Reproductive Potential

FDA is committed to protecting public health by working to secure the drug supply chain against counterfeit and unapproved medications that enter the United States through fraudulent sources. Picture of authentic bottle of Eli Lilly’s Cialis 20 mg Tablets sold in the U.S. INDIANAPOLIS, Sept. 21, 2012 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in the European Union (EU), recommending approval of Cialis 5 mg for once daily use for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). The opinion is now referred for final action to the European Commission, which has the authority to approve medicines for the EU. Do not take sildenafil citrate (Revatio®)* with Cialis. What Should I Avoid While Taking Cialis? Do not use other ED medicines or ED treatments while taking Cialis. Do not drink too much alcohol when taking Cialis (for example, 5 glasses of wine or 5 shots of whiskey).

Study / Source	Effectiveness (%)	Comments
Clinical Trial 2022	70-80%	Used in men with ED
Patient Surveys	75%	Reported satisfaction with Cialis
Comparative Studies	Slightly better than Viagra	Longer duration of effect
Real-world Data	78%	Consistent effectiveness

Drinking too much alcohol can increase your chances of getting a headache or getting dizzy, increasing your heart rate, or lowering your blood pressure.