U.S. Food and Drug Administration |
This article originally appeared in the June 1995 FDA Consumer and contains revisions made in November 1996. It is no longer being updated. |
A vague queasiness stirs in your stomach. Queasy quickly turns to severely nauseated. A sour bubble rises in your throat, and you dash for the bathroom in a cold sweat.
Whatever the cause, the nausea and vomiting of an upset stomach are nasty. Upset stomachs caused by motion or too much food or drink may respond to over-the-counter (OTC) medicines. For other upset stomachs, professional care and no medication often are best.
Motion Sickness
Paleness, yawning and restlessness often precede the nausea, vomiting and dizziness that occur in motion sickness, which most frequently strikes youngsters ages 2 to 12, but may occur at any age.
The primary culprit in this condition is excess stimulation to the inner ear's maze of fluid-filled canals, responsible for maintaining the body's balance. Poor ventilation, anxiety or other emotional upset, and visual stimuli may contribute to motion sickness.
Because motion sickness is easier to prevent than to treat once it has begun, it may help to take an OTC drug to prevent symptoms 30 to 60 minutes before traveling and then continue doses during travel.
The Food and Drug Administration considers four active ingredients to be safe and effective for use in OTC drugs for motion sickness, says Gerald Rachanow, deputy director of the monograph review staff in FDA's Office of OTC Drug Evaluation. The ingredients are cyclizine (Marezine and others), dimenhydrinate (Dramamine and others), diphenhydramine (Benadryl and others), and meclizine (Bonine and others).
The active ingredients in these drugs are antihistamines. Their main side effect is drowsiness. Alcohol, tranquilizers and sedatives may increase this effect. Rachanow says anyone taking a drug for motion sickness should use caution when driving a vehicle or operating machinery and should avoid alcoholic beverages.
In large doses, OTC drugs for motion sickness may cause dry mouth and, rarely, blurred vision. "People with breathing problems such as emphysema or chronic bronchitis, glaucoma, or urinating difficulty due to an enlarged prostate should not take these drugs unless directed to do so by a doctor," Rachanow says.
OTC drugs for motion sickness have the following age restrictions:
FDA recently approved four drugs for OTC use that work systemically to reduce the amount of stomach acid produced. They are also sold by prescription at higher dosage levels to treat gastrointestinal illnesses such as ulcers.
Pepcid AC Acid Controller (famotidine), Tagamet HB (cimetidine), and Axid AR (nizatidine) are marketed OTC as a preventative before consuming food and beverages expected to cause heartburn, acid indigestion, or sour stomach. Pepcid AC and Tagamet HB also are labeled for relief of the symptoms. A fourth acid reducer, Zantac 75 (ranitidine hydrochloride), is labeled only for relief. The drugs are for people age 12 or older.
Users should take no more than four tablets of Tagamet HB or two tablets of the other acid reducers in 24 hours, and should limit use at the maximum dose without consulting a doctor to two weeks. They should consult a doctor if they have swallowing difficulty or persistent abdominal pain, as these symptoms may indicate a more serious condition.
In addition, with Tagamet HB, people should consult their doctor before use if they also take any of these prescription drugs: theophylline (oral asthma medicine), warfarin (blood-thinning medicine), or phenytoin (seizure medicine). If people have questions about whether their medicines contain these drugs or about other drug interactions, they should call the manufacturer, SmithKline Beecham Consumer Affairs, at (1-800) 482-4394.
Most products approved to relieve heartburn, indigestion, or upset stomach from too much food or drink are antacids, which neutralize gastric acidity.
Antacids may contain various active ingredients. The four general categories, with common brands and potential side effects, are:
"Antacids are fast-acting drugs," says Hugo Gallo-Torres, M.D., a medical officer in FDA's division of gastrointestinal and coagulation drug products. "They should bring relief within 15 to 20 minutes of each episode. If, after several episodes, there is no relief, then something else may be going on, something that requires a physician's evaluation."
Antacids may interact with many drugs. Gallo-Torres advises consulting a doctor before using antacids if you have a condition that requires adjusting sodium in your diet, or if you are taking a prescription medicine.
Overindulgence
Bismuth subsalicylate is recommended for overeating and drinking excessively. Bismuth also has some antibacterial effect. The product, sold as Pepto-Bismol and generic brands, may cause a temporary, harmless darkening of the tongue or stool.
FDA has proposed that products containing bismuth subsalicylate have labeling warning not to give the drug to children and teenagers who have or are recovering from chickenpox, flu symptoms (nausea, vomiting or fever), or flu. The warning is needed because, like aspirin, bismuth subsalicylate is a salicylate and may be associated with an increased risk of Reye syndrome, a rare but serious illness that can occur in children and teenagers with those illnesses.
Other proposed warnings advise users not to take the drug if they're allergic to any salicylate, and to consult a doctor first if they have diabetes, gout or arthritis or if they take blood-thinning medicine.
Users are also advised to stop taking the drug if they have ringing in the ears. Rachanow explains: "This may happen when too much drug is taken or when another salicylate, such as aspirin, is taken at the same time."
Viral Infection
Nausea, vomiting and diarrhea may also be due to mild viral gastrointestinal infection. Children are especially susceptible. A doctor should be consulted if vomiting or diarrhea recur or persist, because dehydration or a chemical imbalance may result and require treatment. It is very important that patients recovering from viral gastrointestinal infection drink plenty of fluids.
General Advice
With stomach upsets in general, it's a good idea to call the doctor if symptoms last more than a few days. A doctor should be called if symptoms become severe-for instance:
Women who are pregnant or breast-feeding should consult their doctors before taking any drugs.
Fortunately, most upset stomachs get better by themselves or require minimal treatment. As with any medicine, it's important to read an OTC drug's entire label and follow directions carefully. And, as with any illness, it's important to know when to call the doctor.
Dixie Farley is a staff writer for FDA Consumer.
(This chart is also available as an 8K PDF documen.t)
Drug | Common Brands | Possible Side Effects |
---|---|---|
cyclizine | Marezine | drowsiness; dry mouth; rarely, blurred vision |
dimenhydrinate | Dramamine | same |
diphenhydramine | Benadryl | same |
meclizine | Bonine | same |
Drug | Common Brands | Possible Side Effects |
---|---|---|
sodium salts | Alka-Seltzer Bromo Seltzer |
interference with salt-restricted diet; with sodium bicarbonate to be dissolved in water, risk of stomach rupture if product is not fully dissolved |
calcium salts | Alka-2, Calcium Rich Rolaids, Titralac, Tums | with extended heavy use, kidney stones, reduced kidney function |
aluminum salts | ALternaGEL, Amphogel, Rolaids | constipation; with overuse, weakened bones |
magnesium salts | Camalox, Gelusil, Maalox, Mylanta | laxative effect; with prolonged use, kidney stones; with excessive blood magnesium, problems of the heart, central nervous system, and kidneys |
Drug | Common Brands | Possible Side Effects (seen at higher prescription dosges) |
---|---|---|
famotidine | Pepcid AC Acid Controller | headache, dizziness, constipation, diarrhea |
nizatidine | Axid AR | headache, dizziness |
ranitidine hydrochloride | Zantac 75 | headache, constipation, diarrhea; elevated liver enzymes when given intravenously |
cimetidine | Tagamet HB | headache, diarrhea, diziness, sleepiness; Rx and OTC--drug interactions with theophylline, warfarin or phenytoin |
Drug | Common Brands | Possible Side Effects |
---|---|---|
bismuth subsalicylate | Pepto-Bismol | temporary, harmless darkening of the tongue or stool; risk of Reye syndrome in children or teenagers who have or are recovering from flu or chickenpox; with overuse, ringing in the ears |
Publication No. (FDA) 96-3219
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