Viagra, Cialis Side Effects Linked To High Rate of Hearing Loss in ISMP Report
According to the findings of a new report that analyzed adverse events submitted to federal drug regulators, there is increasing evidence that the erectile dysfunction drugs Viagra and Cialis may cause hearing loss among men.
The Institute for Safe Medication Practices (ISMP) issued the latest edition of its QuarterWatch report (PDF) last week, which monitors all problems submitted through the FDA Adverse Event Reporting System (FAERS), indicating that there is new evidence that side effects of Viagra and Cialis may cause sudden loss of hearing in one or both ears.
In 2007, the FDA issued a hearing loss warning for Viagra, Cialis and Levitra, as well as the pulmonary hypertension drug Revatio. All of the medications belong to a class of drugs known as phosphodiesterase type 5 (PDE5) inhibitors. At the time, the agency indicated it had received at least 29 reports of sudden hearing loss that occurred within hours or days of using the drugs.
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Side Effects of Viagra Linked to Risk of Melanoma Skin Cancer
Learn More About this Lawsuit SEE IF YOU QUALIFY FOR COMPENSATIONThe new ISMP report found that over the last year there were at least 180 reports of Cialis or Viagra hearing loss, indicating that the risk of hearing loss was 21.5 times higher for those who used the drugs compared to those who did not.
Cialis was linked to the highest rate of hearing loss, at nearly 30 times higher than normal, and appeared to be linked to cases with the most severe hearing loss effects. There were not enough cases to make an effective evaluation of Levitra.
ISMP researchers looked at data on every new adverse event report submitted to the FDA over the four calendar quarters ending in the third quarter of 2015. There were only 214 reports of deafness over that time period in total, but Cialis accounted for 152 of those cases and Viagra was linked to 28 of the reports. None were associated with Levitra, but researchers noted that Levitra only received 116 adverse event reports overall and said the sample size was too small.
“These new data extend and confirm the association between sudden hearing loss and PDE5 agents,” the report concludes. “Evidence to support a causal relationship includes evidence from clinical trials, case reports of immediate onset, adverse drug events from multiple countries over many years’ time, and includes analysis of individual cases and the quantitative assessment reported here.”
In the FDA’s 2007 warning, the agency urged individuals who experience sudden hearing loss after taking an erectile dysfunction drug to contact their doctors immediately and stop taking the medication.
Viagra and Cialis are both blockbuster medications that have been used by millions of men throughout the United States for treatment of erectile dysfunction. While the drugs have become widely used amid the belief that they are safe and carry few side effects, increasing evidence continues to emerge about potentially serious health risks.
In recent years, studies have examined a potential link between Viagra and melanoma. In April 2014, Harvard researchers found that men using the medication may be 84% more likely to be diagnosed with the aggressive and potentially life-threatening form of skin cancer.
Pfizer currently faces dozens of Viagra melanoma lawsuits brought by men throughout the U.S., which allege that the drug maker knew or should have known that the erectile dysfunction drug may increase the risk of skin cancer, yet withheld information from consumers and the medical community.
Last week, the U.S. Judicial Panel on Multidistrict Litigation decided to consolidate all Viagra cases involving melanoma pending in U.S. District Courts nationwide, for coordinated discovery and pretrial proceedings. However, if Pfizer fails to reach Viagra skin cancer settlements or otherwise resolve the litigation, each case may be remanded back to the venue where it was filed for an individual trial date in the future.
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14 Comments
PaulApril 3, 2023 at 8:54 pm
This all makes sense now. Awful ringing in the ears. Getting worse and worse. The relationship with viagra is now very obvious to me now. I feel used like we are just products for BIG PHARMA to make profits no matter the cost. Scandalous
TomNovember 30, 2022 at 11:15 am
Was prescribed tadalafil to treat enlarged prostate. At the same time doctor told me i could take it infrequently to counter stress related ED . One morning after taking the previous day one 5mg pill , i woke up with deafness in my right ear and ringing . Went to doctor 2 days later as i originally thought i might have contracted a cold or virus and would come back on its own. Doctor diagnosed 40[Show More]Was prescribed tadalafil to treat enlarged prostate. At the same time doctor told me i could take it infrequently to counter stress related ED . One morning after taking the previous day one 5mg pill , i woke up with deafness in my right ear and ringing . Went to doctor 2 days later as i originally thought i might have contracted a cold or virus and would come back on its own. Doctor diagnosed 40% loss of hearing and prescribed medrol cortisone high doses but ruled out it being from medication or tadalafil. Cortisone helped and i got my hearing back after 2 weeks. As I was assured it was not from the tadalafil I used it a couple of times after until again , one morning after taking it , i woke up with no hearing again. Visited doctor and was again given high doses of cortisone. 1 Month later i regained my hearing for the most part however a number of other doctors are oblivious to the fact that tadalafil causes this . If it was not for my own research I would still be on it battling hearing loss. This is a disgrace that this drug isnt banned ! It can seriously destroy quality of life . Loosing your hearing is no small deal not is it an acceptable tradeoff for solving ED.
DavidAugust 17, 2022 at 5:42 am
I took silidafil only on occasion and only half a pill. Now I have lost most hearing in my right ear. Cause seems to be related to GERD. Stomach acids pushing up into the middle ear. This drug relaxes the valve between your stomach, and the acids infect or damage the ear. It should be banned. As a mechanic and a guitarist, has ruined my life.
CharlesAugust 13, 2022 at 8:35 am
I'm going back and forth over the last 7 years using Viagra and levitra generic from a Canadian pharmacy. The last year I noticed a slight ringing in my ears and was told by an ENT that I had tinnitus. Over the next 6 months it progressed and got louder. I noticed the next morning after taking generic levitra that I felt a pop sensation in both ears like you experience when flying at high altitude[Show More]I'm going back and forth over the last 7 years using Viagra and levitra generic from a Canadian pharmacy. The last year I noticed a slight ringing in my ears and was told by an ENT that I had tinnitus. Over the next 6 months it progressed and got louder. I noticed the next morning after taking generic levitra that I felt a pop sensation in both ears like you experience when flying at high altitude. After 1 to 2 days each year opened back up like pressure had been released but the ringing had grown louder to this day my tinnitus is now almost unbearable and the ENT says there's nothing they can do I recently found this website and I am not taking those two drugs anymore. There should be a warning label on these drugs use at your own risk
JohnMay 29, 2022 at 9:06 pm
Generic cialis for 2 years. Lost 50% of hearing in left ear. Not optimistic it will come back
JohnMarch 6, 2022 at 9:53 am
I took generic Viagra on Thursday and at 4:00 am I woke up with a loud ringing in my right ear, hearing loss and my inner ear twitching. It's Sunday morning and the ringing has gone away but the hearing loss (about 40%) remains and I can hear the blood pumping in my ear. That was just one dose and am afraid to take more. I will call the doctor on Monday.
EricFebruary 9, 2022 at 8:16 pm
A lifetime Passion of performing, recording, and in the past few years, producing music all came to a screeching halt in approximately 2 seconds. I had been particularly invested in this life long musical endeavor over the last five years, training every single day for a post retirement career of television and movie scoring and sound production. It's all gone now, because of the Cialis I was[Show More]A lifetime Passion of performing, recording, and in the past few years, producing music all came to a screeching halt in approximately 2 seconds. I had been particularly invested in this life long musical endeavor over the last five years, training every single day for a post retirement career of television and movie scoring and sound production. It's all gone now, because of the Cialis I was prescribed to take daily by my doctor. If Eli Lily and others have known that drugs such as these can do these horrific things to us and allow it to stay on the market, then they WILL be held accountable. I'm now left with 0% hearing in my left ear. What little treatments that are available have done nothing for me. I'm not just angry and devastated, I feel a responsibility to help stop this from happening to others. Profit is what makes it's the world go round, I get that, but it shouldn't be at the cost of people's lives. It's a calculated risk THEY are willing to take. I'm not, but that risk was taken anyway, and is by millions of people who likely, as did I, have no idea this was even a problem. There is nothing I can do to fix this or my future career that is GONE.
BobDecember 31, 2021 at 6:25 pm
Taking 5mg Tadalafil daily for about two years. Sometimes a 10 mg pill. On Oct. 11 my right hear felt like it popped and then couldn't hear sound, only a high pitch tone. Felt like something stuffed in my ear. Saw the ENT four days later, he prescribed prednisone for a week and Lipo Flavanoid vitamins. Improved about 50% over a month but still have tested a noticeable lack of hearing. Dr then[Show More]Taking 5mg Tadalafil daily for about two years. Sometimes a 10 mg pill. On Oct. 11 my right hear felt like it popped and then couldn't hear sound, only a high pitch tone. Felt like something stuffed in my ear. Saw the ENT four days later, he prescribed prednisone for a week and Lipo Flavanoid vitamins. Improved about 50% over a month but still have tested a noticeable lack of hearing. Dr then did a procedure to inject steroid directly into the ear drum. Not fun. Two months out now and still no noticeable improvement. This is the first time I've heard about hearing loss with Tadalifil. My prescribing GP never mentioned this, and even though I listed the drug on my chart, the ENT never picked up on this. If this is true, this sucks and is not acceptable.
Anon.November 30, 2021 at 11:21 pm
Been using generic cialis (tadalafil) for a few years now, but infrequently. Last few years it's been half a regular pill (10mg) about once or twice a week. Hearing loss in right ear, tinnitus getting worse. 38yo.
EricNovember 30, 2021 at 8:11 am
Started taking cialis about two weeks ago and just 2 days ago experienced a significant loss of hearing. Stopped taking the drug immediately. Have Dr appointment today
MARCOAugust 20, 2021 at 1:13 pm
Felt pop in ear and days after ringing started getting worse with time.
ReneeApril 16, 2021 at 9:55 pm
Hearing loss in both ears right one 87% and left 49%
RonaldDecember 17, 2019 at 12:47 am
HEARING loss in right ear after taking generic cialis
ValerieNovember 29, 2017 at 3:05 pm
65% hearing loss in left ear after two years of sildenafil