Pronunciation:

fam-OH-ti-deen

Brand Names:

• Heartburn Relief
• Pepcid
• Pepcid AC

Dosage Forms:

• Tablet
• Powder for Suspension

Classifications:

Therapeutic—

Gastrointestinal Agent

Pharmacologic—

Histamine H2 Antagonist

Uses of This Medicine:

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.

Before Using This Medicine:

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.

Children—

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.

Older adults—

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.

Breast-feeding—

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.

Other medicines—

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
• Buprenorphine
• Bupropion
• Buserelin
• Cefuroxime Axetil
• Ceritinib
• Chloroquine
• Citalopram
• Clarithromycin
• Clofazimine
• Clothiapine
• Clozapine
• Crizotinib
• Dabrafenib
• Dasatinib
• Degarelix
• Delamanid
• Delavirdine
• Deslorelin
• Deutetrabenazine
• Dexmedetomidine
• Domperidone
• Donepezil
• Efavirenz
• Encorafenib
• Entrectinib
• Erlotinib
• Escitalopram
• Etrasimod
• Fexinidazole
• Fingolimod
• Fluconazole
• Fluoxetine
• Formoterol
• Fosamprenavir
• Foscarnet
• Fostemsavir
• Gefitinib
• Gepirone
• Glasdegib
• Gonadorelin
• Goserelin
• Histrelin
• Hydroxychloroquine
• Hydroxyzine
• Infigratinib
• Inotuzumab Ozogamicin
• Ivabradine
• Ivosidenib
• Ketoconazole
• Ledipasvir
• Lefamulin
• Lenvatinib
• Leuprolide
• Levofloxacin
• Lofexidine
• Macimorelin
• Methadone
• Methylphenidate
• Metronidazole
• Mirtazapine
• Mobocertinib
• Moxifloxacin
• Nafarelin
• Neratinib
• Nirogacestat
• Octreotide
• Olanzapine
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Ozanimod
• Pacritinib
• Panobinostat
• Paroxetine
• Pasireotide
• Pazopanib
• Phenobarbital
• Pimavanserin
• Pitolisant
• Ponesimod
• Posaconazole
• Primidone
• Quetiapine
• Quizartinib
• Relugolix
• Ribociclib
• Rilpivirine
• Secretin Human
• Selpercatinib
• Sertraline
• Sevoflurane
• Siponimod
• Solifenacin
• Sotalol
• Sotorasib
• Sparsentan
• Sulpiride
• Sunitinib
• Tacrolimus
• Tizanidine
• Tolazoline
• Trazodone
• Triclabendazole
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Vismodegib
• Voclosporin
• Zuclopenthixol

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 of This Medicine:

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.

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 While Using This Medicine:

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 of This Medicine:

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.