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ranitidine

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Brand names: Zantac

H2 Receptor Antagonist OTC

Ranitidine (Zantac) helps reduce stomach acid. It can relieve heartburn and sour stomach.

What it does

This medicine treats heartburn caused by acid indigestion and sour stomach.

Common side effects

Headache

Key warnings

There are no boxed warnings in the provided data.

How It Works

Ranitidine is an H2 receptor antagonist. It works by blocking histamine. Blocking histamine reduces the amount of acid your stomach makes.

How to Take It

Adults and children 12 years and older can take this medicine. To relieve symptoms, swallow 1 tablet with a glass of water. To prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating or drinking. You can take it up to twice a day, but do not take more than 2 tablets in 24 hours. Children under 12 years should ask a doctor.

Pregnancy & Breastfeeding

There is no information about pregnancy or breastfeeding in the provided data. Talk to your doctor if you are pregnant or breastfeeding.

Missed Dose

If you miss a dose, take it as soon as you remember. Do not take more than 2 tablets in 24 hours.

Storage

Store this medicine as directed by your doctor or pharmacist.

Side Effects (from patient reports)

Based on 139,052 FDA adverse event reports.

Breast cancer
24,853
Prostate cancer
22,252
Colon and rectal cancer
17,674
Bladder cancer
16,746
Kidney cancer
16,278
Esophageal cancer
9,648
Wrong dose given
9,631
Liver cancer
7,592
Stomach cancer
7,538
Pancreatic cancer
6,840

FDA Adverse Event Report Analysis

Detailed analysis of 197,405 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 1999–2025.

Total Reports

197,405

Death-Related Reports

15,440

Hospitalization Reports

25,953

Top Indication

Dyspepsia

Gender Distribution

Female 90,213 (52%)
Male 83,162 (48%)

Age Distribution

0–17 3,109
18–44 13,417
45–64 43,800
65–74 20,606
75+ 11,493

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 BREAST CANCER 24,853
2 PROSTATE CANCER 22,252
3 COLORECTAL CANCER 17,674
4 BLADDER CANCER 16,746
5 RENAL CANCER 16,278
6 OESOPHAGEAL CARCINOMA 9,648
7 INCORRECT DOSE ADMINISTERED 9,631
8 HEPATIC CANCER 7,592
9 GASTRIC CANCER 7,538
10 PANCREATIC CARCINOMA 6,840
11 LUNG NEOPLASM MALIGNANT 6,759
12 NAUSEA 4,715
13 CHRONIC KIDNEY DISEASE 4,687
14 FATIGUE 4,464
15 DRUG INEFFECTIVE 4,031

Reactions in Death Reports

DEATH 2,248
PANCREATIC CARCINOMA 1,995
HEPATIC CANCER 1,871
NEOPLASM MALIGNANT 1,623
OESOPHAGEAL CARCINOMA 1,456
GASTRIC CANCER 1,233
LUNG NEOPLASM MALIGNANT 1,139
COLORECTAL CANCER 1,013
INCORRECT DOSE ADMINISTERED 971
BLADDER CANCER 883

Reactions in Hospitalization Reports

NAUSEA 2,042
DIARRHOEA 1,967
DYSPNOEA 1,934
VOMITING 1,870
PNEUMONIA 1,740
FATIGUE 1,719
PAIN 1,521
OFF LABEL USE 1,492
PYREXIA 1,404
ASTHENIA 1,390

Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

There are no boxed warnings in the provided data.

Known Drug Interactions

Dose adjustment is not recommended for risperidone tablets when co-administered with ranitidine, cimetidine, amitriptyline, or erythromycin [see Table 18 ] . Do not exceed twice the patient’s usual dose Enzyme (CYP3A) inhibitors Ranitidine 150 mg twice daily 1 mg single dose 1.2 1.4 Dose adjustment not needed Cimetidine 400 mg twice daily 1 mg single dose 1.1 1.3 Dose adjustment not needed Erythromycin 500 mg four times daily 1 mg single dose 1.1 0.94 Dose adjustment not needed Other Drugs Amitriptyline 50 mg twice daily 3 mg twice daily 1.2 1.1 Dose adjustment not Needed *Change relative t...

Mechanism: Ranitidine causes a small increase in risperidone levels, but it is not enough to change how the drug works or its safety.

What to do: No dose adjustment is necessary when these two medications are used together.

albuterol, systemic and inhaled mebendazole amoxicillin medroxyprogesterone ampicillin, with or without sulbactam methylprednisolone atenolol metronidazole azithromycin metoprolol caffeine, dietary ingestion nadolol cefaclor nifedipine co-trimoxazole (trimethoprim and sulfamethoxazole) nizatidine diltiazem norfloxacin dirithromycin ofloxacin enflurane omeprazole famotidine prednisone, prednisolone felodipine ranitidine finasteride rifabutin hydrocortisone roxithromycin isoflurane Sorbitol (purgative doses do not inhibit theophylline absorption) isoniazid sucralfate isradipine terbutaline, s...

Mechanism: Ranitidine can slow down how quickly your liver processes theophylline, which may cause the drug to build up to unsafe levels in your body.

What to do: Your doctor may need to check your blood levels more frequently and adjust your dose if necessary.

Cimetidine and Ranitidine Cimetidine and ranitidine do not affect the clearance of valproate.

Mechanism: Ranitidine does not change how the body processes or removes valproate from your system. There is no known interaction between these two drugs based on the provided information.

What to do: These medications can be taken together as prescribed. No dosage adjustments are usually necessary.

moderate midazolam

Other Drug Interactions Caution is advised when midazolam is administered concomitantly with drugs that are known to inhibit the P450-3A4 enzyme system such as cimetidine (not ranitidine), erythromycin, diltiazem, verapamil, ketoconazole and itraconazole. The effect of single oral doses of 800 mg cimetidine and 300 mg ranitidine on steady-state concentrations of midazolam was examined in a randomized crossover study (n=8). Ranitidine increased the mean steady-state concentration to 62 ng/mL.

Mechanism: Ranitidine can cause midazolam levels to build up in your body. This happens because the drug is processed more slowly than usual.

What to do: Use caution when taking these medicines together. Your doctor may need to watch you closely for extra sleepiness.

Effect of Other Drugs on the Pharmacokinetics of Clonazepam: Literature reports suggest that ranitidine, an agent that decreases stomach acidity, does not greatly alter clonazepam pharmacokinetics.

Mechanism: Ranitidine reduces stomach acid but does not have a major effect on how clonazepam moves through your body.

What to do: No specific action is typically required when taking these medications together.

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Common Questions

What is ranitidine used for?
It relieves and prevents heartburn and sour stomach.
How often can I take ranitidine?
You can take it up to twice a day.
Can children take ranitidine?
Children 12 and over can take the adult dose. Children under 12 should ask a doctor.
How long before eating should I take ranitidine?
Take it 30 to 60 minutes before eating or drinking.
How many tablets can I take in a day?
Do not take more than 2 tablets in 24 hours.
What should I do if I miss a dose?
Take it as soon as you remember.
Can I take ranitidine while pregnant?
Ask your doctor if you are pregnant.
Can I take ranitidine while breastfeeding?
Ask your doctor if you are breastfeeding.
Does ranitidine have side effects?
Headache is a common side effect.
How should I store ranitidine?
Store this medicine as directed by your doctor or pharmacist.
What are the common side effects of ranitidine?
The most commonly reported side effects of ranitidine include Headache. Based on 139,052 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does ranitidine interact with other medications?
Yes, ranitidine has 15 known drug interactions. Notable interactions include risperidone, theophylline, valproate. Always inform your doctor about all medications you are taking.
What drug class is ranitidine?
ranitidine belongs to the H2 Receptor Antagonist drug class. It is available over the counter (OTC). This medicine treats heartburn caused by acid indigestion and sour stomach.
Is ranitidine safe during pregnancy?
There is no information about pregnancy or breastfeeding in the provided data. Talk to your doctor if you are pregnant or breastfeeding. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.
Has ranitidine been recalled?
There are 12 recalls associated with ranitidine products. CGMP Deviations: Presence of NDMA impurity detected in product. Check the recalls section below for full details and affected products.

Active Recalls

Class II December 17, 2019

CGMP Deviations: Presence of NDMA impurity detected in product.

Glenmark Pharmaceuticals Inc., USA

Class II December 17, 2019

CGMP Deviations: Presence of NDMA impurity detected in product.

Glenmark Pharmaceuticals Inc., USA

Class II December 17, 2019

CGMP Deviations: Presence of NDMA impurity detected in product.

Glenmark Pharmaceuticals Inc., USA

Class II December 17, 2019

CGMP Deviations: Presence of NDMA impurity detected in product.

Glenmark Pharmaceuticals Inc., USA

Class II December 13, 2019

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Granules India Limited

Class II November 22, 2019

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Amneal Pharmaceuticals, Inc.

Class II November 6, 2019

CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

AuroMedics Pharma LLC

Class II October 22, 2019

CGMP Deviations: Presence of NDMA impurity detected in product.

Sanofi-Aventis U.S. LLC

Class II October 22, 2019

CGMP Deviations: Presence of NDMA impurity detected in product.

Sanofi-Aventis U.S. LLC

Class II October 22, 2019

CGMP Deviations: Presence of NDMA impurity detected in product.

Sanofi-Aventis U.S. LLC

Class II October 22, 2019

CGMP Deviations: Presence of NDMA impurity detected in product.

Sanofi-Aventis U.S. LLC

Class II October 22, 2019

CGMP Deviations: Presence of NDMA impurity detected in product.

Sanofi-Aventis U.S. LLC

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Medication Guides

Related Health & Safety Data

What the FDA Data Shows for ranitidine

The FDA label for ranitidine (sold under brand names such as Zantac) classifies it as an over-the-counter product in the H2 Receptor Antagonist class. This medicine treats heartburn caused by acid indigestion and sour stomach. Official labeling lists 1 commonly reported side effect, including Headache.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 139,052 voluntary reports. The database also lists 15 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. Acquisition-cost data is surveyed weekly by CMS and updated as manufacturers report changes.

Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 12 recall records on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.

Last updated: May 23, 2025

All federal data sources used on this page