Sildenafil Package Insert – What’s this FDA Approved Drug For?

Sildenafil Citrate is commonly heard or spoken about in the market for erectile dysfunction. This is because it is one of the most effective agents when it comes to erectile dysfunction treatment in males. You may not have heard of Sildenafil Citrate yet, but you may have already come across Viagra—this product is one of the most prominent drugs when it comes to impotence treatment in males.

ra is from the renowned company Pfizer, a multinational, massive company stationed in New York. Viagra is Pfizer’s brainchild and one of its most popular drugs and is currently the only brand-name drug for erectile dysfunction approved by the US FDA (save for Sildenafil TEVA from TEVA Israel). Generic alternatives exist for this product, but they are still unapproved in some countries, like the United States.

Sildenafil FDA Approval for Pulmonary Hypertension

Sildenafil Citrate’s discovery is a unique one. It was initially developed by Pfizer as an angina treatment. However, the drug was ineffective for angina treatment but gave peculiar side effects in the male participants. Instead of improving angina, Sildenafil Citrate actually improved erectile function in patients—and the rest is history.

The drug Sildenafil Citrate was developed as an impotence treatment in male patients and was later on approved by the Food and Drug Administration in 1998, hence its US-wide and worldwide marketing as “Viagra”, the famous impotence medication.

Besides for erectile dysfunction, the FDA also came to approve the drug Sildenafil for the management of pulmonary arterial hypertension (PAH) in patients. On June 3, 2005, FDA formally announced its approval of Sildenafil 20 mg as a treatment for early PAH and as an agent for improving exercise        ability in patients. Since the drug Sildenafil Citrate 20mg demonstrated satisfactory effects in patients suffering from PAH and has significantly improved their exercise tolerance as opposed to placebo. However, patent approvals for generic Sildenafil 20 mg counterparts are served by since 2012, unlike Viagra’s generic counterparts, which are still unapproved by the FDA (save for Sildenafil TEVA).

Here are several FDA-approved brands for Sildenafil 20 mg (generic counterparts of Revatio):

  • Apotex Corp (November 2012)
  • Dr. Reddys Labs Ltd (November 2012)
  • Torrent Pharms Ltd (November 2012)
  • Watson Labs Inc (November 2012)
  • TEVA Pharms (January 2013)
  • Amneal Pharms  (February 2013)
  • Macleods Pharms Ltd (December 2013)
  • Hetero Labs Ltd V (November 2014)
  • Aurobindo Pharma Ltd (November 2015)
  • Mylan Pharms Inc (June 2016)

This is not a complete list of the FDA-approved generic drugs for PAH although this can list can be a mini-guide for buyers looking for generic brands actually approved by the US FDA for PAH treatment.

Revatio Prescribing Information

Revatio and other generic Sildenafil Citrate 20 mg products are solely intended for the management of pulmonary hypertension in patients. According to Revatio prescribing information from the FDA, Revatio has several dose formulations available: tablets, oral suspension, injection, and powder for oral suspension.

The approved dose for patients with preliminary PAH is 5 or 20 mg, thrice a day for tablets and oral suspension. On the other hand, the injection dose for Revatio in PAH is 2.5 or 10 mg, also thrice a day.

Revatio Package

Revatio Package

As for Sildenafil for impotence, patients are advised to take 25 mg to 100 mg as needed, and only once in a period of 24 hours. In some cases, patients are assigned by their doctors generic Sildenafil 20 mg instead of the Viagra 25-100mg tablets due to the immense expense incurred by the brand product. Since Sildenafil Citrate 20 mg generic counterparts are available at local drugstores in the US, patients are prescribed by their doctors with the 20 mg product and are only advised to adjust their intake of the drug.

Side effects identified for Sildenafil include hypotension, epistaxis, headache, flushing, dyspepsia, and changes in vision.

Tadalafil Package Insert

Another world-famous impotence treatment is the drug Tadalafil, or commonly known by its trade name Cialis, from the company Eli Lilly and Company in the United States. It is gaining popularity amongst impotence users due to its excellent and lasting effect (has a 36-hour duration in the body as opposed to Sildenafil’s 4-hour effect).

Tadalafil Package – Cialis 20 mg Tablets from Eli Lilly

Tadalafil Package – Cialis 20 mg Tablets from Eli Lilly

Besides erectile dysfunction, though, the drug Cialis, according to its FDA prescribing information, the drug is intended for patients with benign prostatic hyperplasia (BPH) or enlargement of the prostate. Cialis helps patients relieve urinary retention in patients suffering from enlarged prostates.

Tadalafil in the form of Cialis is also significant for its daily dose option, as opposed to Sildenafil’s as needed use. Patients can treat Cialis daily as a “maintenance” treatment, helping the males remove their time concerns that come with the use of impotence treatments. The on-demand dose of Cialis, too, makes for fewer time concerns due to its staggering 36-hour effect in the patients.

Patients are prescribed with Cialis in 10-20mg on demand and 2.5-5mg daily. As for side effects, patients taking the drug may experience headache, myalgia, back pain, flushing, limb pain, and nasal congestion.


Sildenafil Citrate is used for the management of erectile dysfunction and in preliminary pulmonary arterial hypertension. Trade names of Sildenafil Citrate include Viagra for ED and Revatio for PAH. Generic options are available for both drugs, but the US FDA has yet to approve generic counterparts for Viagra (especially in the US); Sildenafil 20 mg generic counterparts, though, are already accessible at the local pharmacy level. Since Viagra is expensive and there are no approved generic Sildenafil 25 to 100 mg at US local pharmacies, buyers should consider getting their generic Viagra online, preferably at safe stores like the ones included on our list of Top Online Pharmacies.