Heartburn Relief (Oral)

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 stomach acid comes back up into the esophagus. It is also used to treat certain conditions that involve too much acid in the stomach (for example, Zollinger-Ellison syndrome, multiple endocrine neoplasia).

Famotidine is part of a group of medicines called histamine H2-receptor antagonists or H2-blockers. It works by reducing the amount of acid the stomach produces.

This medicine is available with your doctor's prescription and also without a prescription. The prescription form contains more medicine in each tablet. Your doctor will give you specific instructions on how to use it and the correct dose for your medical issue.

It is very important for your doctor to check your or your child's progress during regular visits to ensure this medicine is working properly. Blood and urine tests may be needed to look for unwanted effects.

If your condition does not improve, or if it gets worse, contact your doctor.

Contact your doctor right away if you have any of the following symptoms: confusion, delirium, hallucinations, disorientation, agitation, seizures, or unusual drowsiness, dullness, tiredness, weakness, or feeling sluggish. These symptoms are more likely to happen if you are older or if you have kidney disease.

Get in touch with your doctor immediately if there are any changes in your or your child's heart rhythm. You or your child may feel dizzy or faint, or experience a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you have had a heart rhythm issue, such as QT prolongation.

Do not take any other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. For this medicine, consider the following:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your health care professional if you have any other allergies, such as food, dyes, preservatives, or animal allergies. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not shown any specific problems in children weighing 40 kilograms (kg) or more that would limit the use of famotidine. However, safety and effectiveness have not been established in children for treating conditions that cause too much stomach acid or for preventing ulcers from coming back.

Geriatric

Studies have not shown any specific problems in the elderly that would limit the use of famotidine. However, older patients are more likely to have kidney problems related to aging, which may require a dose adjustment for patients taking famotidine.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. You should weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to adjust the dose or take other precautions. When you are taking this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are based on their potential significance and may not include all possibilities.

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 necessary in some cases. If both medicines are prescribed together, your doctor may adjust 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
• 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
• Vilanterol
• Vinflunine
• Vismodegib
• Voclosporin
• Zuclopenthixol

Using this medicine with any of the following medicines may increase the 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 adjust the dose or how often you use one or both of the medicines.

• Cefditoren Pivoxil
• Cefpodoxime Proxetil
• Cyclosporine

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used at or around the time of eating food or certain types of food because interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions. The following interactions are based on their potential significance and may not include all possibilities.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Make sure to tell your doctor if you have any other medical issues, especially:

• Kidney disease, moderate to severe—Use with caution. The effects may be stronger because the medicine is removed from the body more slowly.

Along with its necessary effects, this medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, you might need medical attention.

Check with your doctor right away 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 happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also offer ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, 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 happen 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.

In the U.S.

• Heartburn Relief
• Pepcid
• Pepcid AC

Available Dosage Forms:

• Tablet
• Powder for Suspension

Therapeutic Class: Gastrointestinal Agent

Pharmacologic Class: Histamine H2 Antagonist

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.

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