Do you read the labels on OTC pain relievers? Be honest now. The last time you purchased Advil, Motrin IB or some house brand ibuprofen pills, did you check out the dosage instructions or the warnings on the label? Do you know what ibuprofen side effects you should be watching for? Even if you read the label on OTC nonsteroidal anti-inflammatory (NSAID) products you may not be informed of all the potential serious complications.
Ibuprofen Side Effects:
- Heartburn, abdominal pain, nausea, vomiting
- Ulcers, bleeding ulcers, perforated ulcers
- Headache, dizziness, drowsiness, disorientation
- Skin rash, sensitivity to sunlight, itching
- Fluid retention, high blood pressure
- Heart failure, heart attack, stroke
- Irregular heart rhythms (AFib)
- Ringing in ears, hearing changes
- Visual disturbances
- Liver damage, kidney damage
Overdosing on NSAIDs:
A new study suggests that many people exceed the daily limit of OTC ibuprofen (Pharmacoepidemiology & Drug Safety, Jan. 26, 2018). They may also take two different NSAIDs during the same day, without realizing it.
Someone might be relying on Motrin IB for a backache during the day and Aleve PM to get to sleep at night. The Motrin IB contains ibuprofen and the Aleve contains naproxen. Both are NSAIDs.
Another example: someone may be taking Advil for a headache and also taking Dristan Sinus for nasal congestion. The two products contain ibuprofen, so it would be like doubling the dose. That could also lead to an increased risk of ibuprofen side effects.
NSAID Dosing Confusion:
We found one especially intriguing aspect to the new study. Most people assume that the proper dose of OTC pain relievers is 2 pills. That’s presumably because they are used to taking two Tylenols, two aspirin tablets or two ibuprofen pills at a time. It turns out that some of the cold, flu and allergy meds that contain ibuprofen suggest 1 pill dosing. And the instructions on the label of Aleve are different from the dosing recommendations for Advil.
Aleve Dosing Directions:
“What are the daily and maximum doses for adults?
“Take one tablet, caplet, gelcap or liquid gel every 8 to 12 hours while symptoms last. For the first dose, you may take 2 pills within the first hour.
“Do not exceed more than 2 tablets, caplets, gelcaps or liquid gels in 12 hours, and do not exceed 3 tablets, caplets, gelcaps or liquid gels in 24 hours. The smallest effective dose should be used. Drink a full glass of water with each dose.
“Do not take for more than 10 consecutive days for pain or 3 days for fever, unless directed by a doctor”
Advil Dosing Directions:
“Adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist
“If pain or fever does not respond to 1 tablet, 2 tablets may be used
“Do not exceed 6 tablets in 24 hours, unless directed by a doctor”
If someone were to take Aleve the way they take Advil (up to 6 pills a day) they would be doubling the daily limit and increasing the risk for adverse reactions.
Ibuprofen: The Most Popular NSAID in the Pharmacy
Americans are in a LOT of pain. That’s why the number one drug in the U.S. is acetaminophen (Tylenol). According to the latest Pharmacoepidemiology & Drug Safety study: ibuprofen
“…is the second or third most‐commonly‐used drug in the US after acetaminophen, and the most‐commonly‐used non‐aspirin NSAID.
“While NSAIDs are effective for their intended purposes, they also have considerable side effects which are generally dose related and can be fatal, including major upper gastrointestinal bleeding, acute renal injury, and cardiovascular outcomes such as myocardial infarction and stroke.”
Not Reading the Label:
Many people who use nonprescription drugs don’t read the label carefully. They may assume that if the FDA saw fit to make a drug available without a prescription then it must be quite safe.
The new study of 1,326 people found that 15 percent of them took more than the maximum recommended dose. The volunteers all filled out online medication diaries every day for a week. All of them used ibuprofen during the week, with 87 percent of them taking the drug without a prescription.
More than half of them took it at least three days a week, with 16 percent taking it every day. More than one-third of them took another drug in the same class. Most of the time that was aspirin or naproxen, and few of the participants realized that they were taking more than one NSAID.
Foreign Experts Weigh in on NSAIDs:
Dr. Gunnar Gislason is director of research for the Danish Heart Foundation in Cophenhagen. He told Reuters:
“I believe that the message sent to the consumer when these drugs are widely available in convenience stores and gas stations is that these drugs are safe and you can use them safely for pain relief – thus no need for reading the label.”
Dr. Liffert Vogt is associated with the Academic Medical Center at the University of Amsterdam in the Netherlands. Neither he nor Dr. Gislason were involved in the NSAID study. Dr. Vogt told Reuters:
“In my opinion NSAIDs should not be available as an over-the-counter drug, because of all their deleterious effects.”
Should the FDA Limit OTC Use of NSAIDs Like Ibuprofen or Naproxen?
We posed that question almost a year ago in this article. The outcry was immediate and intense. People want access to OTC ibuprofen and naproxen no matter what. Many said ibuprofen side effects are not an issue for them.
Angie in Portland, Oregon loves ibuprofen:
“Ibuprofen is the only pain medication that works to stop an absolutely debilitating pain that I get. Thankfully it does not occur all of the time but when it hits Advil works. I have tried aspirin and Tylenol, neither works. I don’t know what I would do without it. I am so grateful it’s available to me.”
Jane in Erie, PA is outraged with the idea of limiting OTC NSAIDs:
“I don’t believe in banning NSAIDs or making them Rx only. People need to read, learn, and take responsibility for what they put in their mouths! I have celiac disease and I am not asking for a ban on gluten.
“Get a grip. I am sick of Big Brother telling us what we can and cannot take! Opioids are a totally different matter, for another discussion. But banning over-the-counter NSAIDs is ridiculous! Get educated, people!”
Klara in Atlanta agrees with Jane:
“I agree with Jane from Erie, PA. LEAVE IBUPROFEN ALONE! I don’t take NSAIDs on a regular basis, but I keep them around for occasional aches and muscle pain and they’re wonderful. I hate it when Big Brother takes a perfectly good OTC medicine away from us or makes us go through gatekeepers to get it. Don’t patronize us! Let everyone decide for himself whether to take it or not.”
Thai has come up with a suggestion that we have long supported:
“I think a middle ground might be the best way to allow purchase of ibuprofen and naproxen. It should be available without having to make a doctor’s appointment. That causes unnecessary expense and limits who can benefit from the real pain relief these OTC drugs provide.
“Requiring a pharmacist’s consultation to explain the serious aspects of taking these drugs before they can be purchased makes good sense. Warnings on packages or literature given with purchase isn’t enough now that it’s known life threatening events can happen when taking these drugs.”
This is called “behind the counter” access. Many other countries have this 3rd category for medications. We even have it in the U.S. for the decongestant pseudoephedrine. That’s because public health officials worry that this drug can be turned into methamphetamine. By requiring the pharmacist to keep track and counsel patients it has presumably limited the amount of illicit meth that is “cooked” in the U.S.
The Down Side of OTC NSAIDs:
Kate suffered a stroke after taking NSAIDs:
“This is alarming to me. I, as many others, assume that if it is sold OTC it must be harmless. I took Aleve fairly frequently for a headache, muscle ache or just having trouble sleeping.
“I had a medium stroke in November. The neurologists cannot find a definitive reason, after many tests. My eating is healthy. I exercise fairly regularly. My blood pressure is very good. I exercise moderation in things. The scary part is that I don’t know how to prevent another one.
After reading this, I am wondering if the use of an NSAID might have been a cause.”
Greg the Pharmacist in Toledo, Ohio shared this story:
“A friend of mine recently ended up in the hospital with ulcers up and down his esophagus from taking high doses of OTC NSAIDs over several months.
“Some doctors question if NSAIDS might do damage to cartilage and stop healing over time.
“Unfortunately Rx to OTC moves are usually done to make money and are not in the best interest of the public.”
Patty reinforces the message of the new study published in Pharmacoepidemiology & Drug Safety:
“I have known people who have taken OTC drugs without paying any attention to the dosage info. They think the pills are harmless. If 1 pill is the dosage, then 4 is better.
“Also OTC and RX drugs may not be for everyday, all day for the rest of your life. Yet, that is what people end up doing. Doctors do not take the time to advise patients on this.”
Deborah in North Carolina also had a stroke:
“I just had a stroke with no risk factors for stroke in family or myself. Of Course, I am on HRT and have been on it since my forties. I had started taking ibuprofen at night to help with sleep when the stroke happened.
“All work ups and tests after the stroke show no risk factors except, of course, maybe from the hormones and of course the ibuprofen. I had one in my sleep without knowing it and had taken an ibuprofen that night.”
Ibuprofen Side Effects: Plausible Denial
People who sell NSAIDs are likely react to a story like Deborah’s with disbelief. They could easily insist that the hormones were responsible. Or her age was the determining factor. It is almost impossible to prove that any given individual experienced a stroke, a heart attack or cardiac arrest because of an NSAID. Ditto for kidney damage or atrial fibrillation. On the other hand, gastroenterologists often link stomach ulcers to drugs like ibuprofen or naproxen without a moment’s hesitation.
People’s Pharmacy Perspective:
We are not advocating that the FDA ban ibuprofen or naproxen. We would like to see these drugs continue to be sold without a prescription. But we would like them sold behind the counter with a pharmacist’s consultation rather than in convenience stores or super markets.
That way people could be warned about symptoms to be alert for and drug interactions that could be dangerous. Doctors who prescribe NSAIDs like celecoxib, diclofenac or meloxicam get detailed warning information about heart attacks, strokes, gastrointestinal bleeding, ulceration and perforation, liver toxicity, hypertension, heart failure, kidney toxicity and serious skin reactions. They are told to:
“Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their healthcare provider immediately.”
Lida is seeking alternatives to acetaminophen and NSAIDS:
“Are there any safe alternatives to reduce pain when needed? I was told to take aspirin to reduce my chances of heart attack or stroke but after using it for awhile it caused stomach inflammation and triggered diverticulitis which I had been keeping in check. Tylenol does nothing to reduce headache pain or pain in other areas.”
In our book, Graedons’ Guide to Alternatives for Arthritis, we offer a variety of non drug options to control pain and inflammation. They include herbs such as ashwagandha, boswellia, turmeric (curcumin), ginger and stinging nettle. There is information on pineapple (bromelain), gelatin and dietary supplements like MSM and SAMe. You can learn much more about these NSAID alternatives and favorite home remedies at this link.
Share your own story about the pros and cons of NSAIDs. Have you ever noticed ibuprofen side effects? Others can benefit from your experience in the comment section below.