Description
Famotidine is used to treat stomach ulcers (gastric and duodenal), erosive esophagitis (heartburn or acid indigestion), and gastroesophageal reflux disease (GERD). GERD is a condition where the acid in the stomach washes back up into the esophagus. It is also used to treat certain conditions where there is too much acid in the stomach (eg, Zollinger-Ellison syndrome, multiple endocrine neoplasia).
Famotidine belongs to the group of medicines known as histamine H2-receptor antagonists or H2-blockers. It works by decreasing the amount of acid produced by the stomach.
This medicine is available with your doctor's prescription and also without a prescription. For the prescription form, there is more medicine in each tablet. Your doctor will have special instructions on the proper use and dose for your medical problem.
This product is available in the following dosage forms:
- Tablet
- Powder for Suspension
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of famotidine in children weighing 40 kilograms (kg) or more. Safety and efficacy have not been established in children to treat conditions causing too much stomach acid and to prevent an ulcer from coming back.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of famotidine in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require an adjustment in the dose for patients receiving famotidine.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Bepridil
- Cisapride
- Dronedarone
- Levoketoconazole
- Mesoridazine
- Pimozide
- Piperaquine
- Saquinavir
- Sparfloxacin
- Terfenadine
- Thioridazine
- Ziprasidone
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Acalabrutinib
- Adagrasib
- Amiodarone
- Amisulpride
- Amprenavir
- Anagrelide
- Apomorphine
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Atazanavir
- Azithromycin
- Bedaquiline
- Buprenorphine
- Bupropion
- Buserelin
- Cefuroxime Axetil
- Ceritinib
- Chloroquine
- Citalopram
- Clarithromycin
- Clofazimine
- Clothiapine
- Clozapine
- Crizotinib
- Dabrafenib
- Dasatinib
- Degarelix
- Delamanid
- Delavirdine
- Desflurane
- Deslorelin
- Deutetrabenazine
- Dexmedetomidine
- Domperidone
- Donepezil
- Efavirenz
- Encorafenib
- Entrectinib
- Erlotinib
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Cefditoren Pivoxil
- Cefpodoxime Proxetil
- Cyclosporine
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Kidney disease, moderate to severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
Take this medicine exactly as directed by your doctor or as directed on the package. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.
Keep using this medicine for the full time of treatment, even if you begin to feel better.
You may take this medicine with or without food.
Measure the oral liquid with a marked measuring spoon or medicine cup. The average household teaspoon may not hold the right amount of liquid.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage forms (suspension, tablets):
- To prevent an ulcer from coming back:
- Adults—20 milligrams (mg) once a day.
- Children—Use and dose must be determined by your doctor.
- To treat erosive esophagitis (heartburn):
- Adults and children weighing 40 kilograms (kg) or more—20 milligrams (mg) 1 or 2 times per day, at the morning and at bedtime, or 40 mg once a day at bedtime for up to 12 weeks.
- Children weighing less than 40 kg—Use and dose be determined by your doctor.
- To treat gastroesophageal reflux disease (GERD):
- Adults and children weighing 40 kilograms (kg) or more—20 milligrams (mg) 2 times per day, in the morning and at bedtime for up to 6 weeks.
- Children weighing less than 40 kg—Use and dose be determined by your doctor.
- To treat stomach ulcers:
- Adults and children weighing 40 kilograms (kg) or more—20 milligrams (mg) 2 times per day, at the morning and at bedtime, or 40 mg once a day at bedtime for up to 8 weeks.
- Children weighing less than 40 kg—Use and dose be determined by your doctor.
- To treat too much stomach acid (Zollinger-Ellison syndrome):
- Adults—20 milligrams (mg) every 6 hours. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- To prevent an ulcer from coming back:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Throw away any unused oral liquid after 30 days.
Precautions
It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
If your condition does not improve, or if it become worse, check with your doctor.
Check with your doctor right away if you have the following symptoms: confusion, delirium, hallucinations, disorientation, agitation, seizures, or unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness. These are more likely to occur if you are older or if you have a kidney disease.
Contact your doctor right away if you have any changes to your or your child's heart rhythm. You or your child might feel dizzy or faint, or you or your child might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you had a heart rhythm problem, such as QT prolongation.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Rare
- Anxiety
- bleeding gums
- blistering, peeling, or loosening of the skin
- blood in the urine or stools
- bloody, black, or tarry stools
- cough
- difficulty breathing
- discouragement
- fast, irregular, pounding, or racing heartbeat or pulse
- feeling sad or empty
- irritability
- lack of appetite
- loss of interest or pleasure
- noisy breathing
- pinpoint red spots on the skin
- seeing, hearing, or feeling things that are not there
- seizures
- swelling around the eyes
- tightness in the chest
- trouble concentrating
- trouble sleeping
- unusual bleeding or bruising
Incidence not known
- Agitation
- blistering, peeling, or loosening of the skin
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest pain
- chills
- clay-colored stools
- dark urine
- diarrhea
- difficulty swallowing
- dizziness or fainting
- fever
- general feeling of tiredness or weakness
- headache
- high fever
- hives, itching, skin rash
- hoarseness
- joint or muscle pain
- large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
- light-colored stools
- lower back or side pain
- nausea
- painful or difficult urination
- pale skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red skin lesions, often with a purple center
- red, irritated eyes
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- stomach pain
- swollen glands
- unpleasant breath odor
- unusual tiredness or weakness
- upper right abdominal pain
- vomiting of blood
- yellow eyes or skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
- Difficulty having a bowel movement
Rare
- Bad, unusual, or unpleasant (after) taste
- bone or muscle pain
- change in taste
- continuing ringing or buzzing or other unexplained noise in the ears
- decreased interest in sexual intercourse
- difficulty in moving
- dry mouth
- dry skin
- feeling of warmth
- hearing loss
- inability to have or keep an erection
- lack or loss of strength
- loss in sexual ability, desire, drive, or performance
- muscle pain or stiffness
- redness of the face, neck, arms and occasionally, upper chest
- redness of the white part of the eyes
- stomach discomfort
- unusual drowsiness
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-20072972
