Histodil

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Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Histodil

Property Description
Active ingredient Cimetidine (INN)
Form Tablet, oral solution, injectable solution
Pharmacological class Histamine H2-receptor antagonist (H2-blocker)
General purpose Reduction of gastric acid
Origin Synthetic compound

What Type of Medicine is Histodil? (Classification and Origin)

Histodil is a pharmaceutical preparation whose active ingredient is the synthetic compound Cimetidine (INN). The drug is classified as a Histamine H2-receptor antagonist (H2-blocker), belonging to the broader category of Antiulcer Agents. Cimetidine functions as a single-ingredient preparation and is chemically an imidazole and guanidine derivative, acting as a systemic agent within the body. This class of agents is clinically recognized for its ability to reversibly inhibit acid production in the stomach, thereby modulating the gastric environment.


Composition and Available Forms of Histodil (Identity and Delivery)

The entire pharmacological identity of the medicine rests on the active component, Cimetidine. This compound is administered to patients in several high-level dosage form(s). These include solid formulations such as tablets for oral use, a liquid oral solution, and a sterile injectable solution for parenteral (intravenous or intramuscular) administration. This array of preparations ensures that the medicine can be delivered via the oral route for sustained effect or parenterally in settings where oral intake may be restricted, utilizing aqueous media and pharmaceutical excipients appropriate for each specific form.


What is the General Purpose of Histodil? (Core Benefit)

The fundamental purpose of Histodil is to achieve a significant and consistent reduction in the volume and acidity of gastric acid. This action is critical for managing clinical situations where excessive acid production contributes to irritation or damage. A typical application is to provide relief for patients experiencing discomfort or heartbeat due to this hyperacidity. By suppressing the potent secretory stimuli, the medicine helps to alleviate the associated pain and discomfort and supports the natural process of tissue healing in the upper digestive tract.

Regulatory References

  1. NCBI Bookshelf: Cimetidine - StatPearls
  2. FDA: Cimetidine Tablets, DailyMed

What side effects are possible with Histodil?

Histodil: Possible side effects and safety information

The safety profile of Histodil (Cimetidine) is documented in official regulatory sources by classifying possible adverse reactions according to the body system affected and their reported frequency of occurrence.

Frequency-Classified Adverse Reactions

Adverse effects are grouped based on the frequency defined in regulatory standards, such as those used by the European Medicines Agency (EMA):

Classification Examples of Documented Effects
Common Headache, dizziness, diarrhea, skin rashes, tiredness, and muscle pain (myalgia).
Uncommon Reversible confusional states, leukopenia, tachycardia, hepatitis, increases in plasma creatinine, gynecomastia, and reversible impotence.
Rare/Very Rare Thrombocytopenia, agranulocytosis, aplastic anemia, anaphylaxis, and heart block.

High-Level Safety Considerations

The most frequently reported adverse effects generally involve the Nervous System (e.g., headache) and the Gastrointestinal Tract (e.g., diarrhea). The regulatory label notes that certain effects, particularly reversible confusional states, are reported predominantly in older and severely ill patients. These states typically develop early in the course of treatment.

Specific effects on the Endocrine System, such as gynecomastia, and reports of reversible impotence are noted, particularly in patients receiving high doses or long-term therapy (one month or longer).

The safety documentation also includes important constraints, such as the statement that symptomatic improvement with Histodil does not preclude the presence of an underlying gastric malignancy. Rare but clinically significant reactions involve the Blood and Lymphatic System, including agranulocytosis and aplastic anemia.

Overdose and Emergency Response

Overdose and Immediate Medical Attention

Taking more than the recommended dose of Histodil can lead to a serious, potentially life-threatening overdose. The FDA has issued warnings that excessive doses may cause seizures, coma, or even death. Urgent medical attention is required immediately if an overdose is suspected.

Overdose effects involve the central nervous system (CNS) and the cardiovascular system, manifesting in symptoms that range from severe sedation to profound excitation.

Overdose Symptoms
CNS Effects: Drowsiness, unsteadiness (ataxia), confusion, delirium, or toxic psychosis. In children, paradoxical excitation (agitation, jitters) and seizures are more common. Severe overdose may progress to coma and respiratory depression.
Anticholinergic/Cardiovascular Effects: Flushing, blurred vision, dry mouth, rapid heartbeat (tachycardia), and inability to pass urine (urinary retention). High doses can also cause cardiac rhythm disturbances.

When to Seek Emergency Help

Immediately call emergency services (such as 911) or contact a Poison Control Center (1-800-222-1222) if any of the following severe symptoms occur or if the person cannot be awakened:

  • Seizures
  • Severe difficulty breathing
  • Loss of consciousness or unresponsiveness
  • Signs of heart problems (e.g., very fast, pounding, or irregular heartbeat)

Recovery from a severe overdose depends on immediate medical intervention to manage life support and treat specific symptoms. Do not attempt to treat a suspected overdose at home without professional medical guidance.

Therapeutic Uses of Histodil

Quick Facts About Histodil

  • May assist in the management of duodenal ulcers.
  • Used to address active benign gastric ulcers.
  • Contributes to the care of gastroesophageal reflux disease (GERD).
  • Employed in the treatment of pathological hypersecretory conditions, such as Zollinger-Ellison syndrome.

Histodil is a medicinal product utilized to support the management of certain conditions related to the stomach and upper gastrointestinal tract. Its use is associated with therapeutic benefit in addressing active ulcers that occur in the duodenum and in the stomach lining. For individuals with duodenal ulcers, Histodil may be used for initial treatment as well as for ongoing maintenance care, which seeks to reduce the probability of recurrence following initial healing.

This medication is also a therapeutic option for individuals experiencing gastroesophageal reflux disease (GERD). In this context, Histodil is intended to provide relief from symptoms and to support the healing of associated erosive damage to the esophagus. Furthermore, it is clinically indicated for the care of pathological hypersecretory conditions, including the complex acid-overproduction seen in Zollinger-Ellison syndrome, to help regulate gastric acid secretion.

Appropriate use of Histodil should always be discussed with a healthcare professional to ensure the therapeutic plan aligns with individual health requirements and clinical objectives.

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Histodil — official regulatory information

Histodil (Cimetidine) eligibility is strictly defined by regulatory documents, distinguishing between permitted use, restrictions, and absolute contraindications.


Eligibility Scope

Classification Population Group / Condition
Populations for whom use is allowed Adults (typically 16 years and older) under standard labeled conditions.
Populations for whom use is contraindicated Individuals with known hypersensitivity to Cimetidine or to other H2-receptor antagonists.
Age-related restrictions Use is not established for most children under 16 years. Over-the-counter formulations are not for use in children under 12 years.
Condition-specific eligibility Patients with impaired renal function require a formal dosage adjustment to remain eligible for use. Use requires caution in patients with pre-existing liver disease.
Pregnancy and lactation status Use during pregnancy and lactation is generally not recommended or advised only if clearly necessary, as the drug is excreted in human milk.

Connection to the overall eligibility profile

The regulatory profile strictly excludes individuals with hypersensitivity to the drug class (absolute contraindication). Eligibility is conditional on the patient's physiological status, with specific restrictions placed on use in patients with impaired kidney function, where clearance of the medicine is altered. Furthermore, use is formally not recommended in most pediatric populations and during breastfeeding, indicating limited established data.

What should I know about interactions with other medicines?

Histodil (cimetidine) can interact with many other prescription and over-the-counter medications, as well as certain foods and supplements. These interactions can alter the levels of either Histodil or the other drug in the body, potentially leading to increased risk of side effects or reduced effectiveness.

Increased Risk of Side Effects

Histodil is known to inhibit certain liver enzymes, primarily Cytochrome P450 (CYP) enzymes, which are responsible for breaking down many drugs. Taking Histodil with the following medications may increase their concentration in the blood, potentially leading to toxicity:

Drug Class / Specific Drug Potential Interaction Outcome
Anticoagulants (e.g., warfarin) Increased blood thinner effect, raising bleeding risk.
Anti-epileptics (e.g., phenytoin) Increased seizure medication levels, raising side effect risk.
Beta-blockers (e.g., propranolol, metoprolol) Increased blood pressure medication levels, potentially causing low blood pressure or slow heart rate.
Anti-arrhythmics (e.g., lidocaine, quinidine) Increased heart medication levels, raising risk of toxicity.
Theophylline (for breathing problems) Increased theophylline levels, raising risk of serious toxicity.
Certain Benzodiazepines (e.g., diazepam) Increased sedative effect and risk of central nervous system side effects.
Tricyclic Antidepressants Increased antidepressant levels, raising side effect risk.

Decreased Drug Absorption

Histodil reduces stomach acid, which can affect the absorption of medications and supplements that require an acidic environment to dissolve properly. Medications that may be less effective when taken with Histodil include certain antifungal medications (e.g., ketoconazole) and certain HIV/antiviral drugs.

Antacids should be taken at least one hour before or after Histodil, as they can decrease Histodil's absorption and effectiveness. Additionally, long-term use may impair the absorption of Vitamin B12 from food.

Mechanism of Action

Histodil (Cimetidine) operates through a selective pharmacodynamic mechanism by targeting the regulatory mechanisms of acid production in the stomach. The mechanism is entirely based on a precise receptor blockade and the resulting signal cascade interruption.

Blocking the Histamine H2 Receptor Signal

Histodil's primary action involves acting as a competitive antagonist at the histamine H2 receptors located on the gastric parietal cells. By binding to these receptors, the drug directly interferes with the ability of the natural signaling molecule, histamine, to initiate the acid-secreting process. This molecular blockade immediately modulates the primary pathway for acid stimulation.

Interruption of the cAMP Secretion Cascade

The receptor blockade leads to a crucial cellular consequence: the H2 receptor is prevented from activating the internal enzyme that produces cyclic AMP ( cAMP), a necessary second messenger. The resulting drop in the cAMP signal prevents the full activation of the Proton Pump ( H^+/ K^+-ATPase), the final machinery for acid transport, resulting in an inhibition of HCl secretion.

Physiological Effect: Modulating Gastric Acidity

By disrupting the cellular regulation of acid production, the mechanism consistently suppresses both basal (continuous) and stimulated (meal-related) acid output. This systemic physiological effect results in a lowering of the hydrogen ion concentration and the overall volume of gastric fluid, thereby altering the hydrogen ion concentration of the gastric fluid.

Dosage and Administration Information

Histodil, which contains Cimetidine, is administered via multiple official routes to ensure systemic availability. The medicine is available for oral intake as tablets or an oral solution, and it may be administered parenterally via intravenous (IV) or intramuscular (IM) injection when oral intake is compromised.

Dosing regimens are precisely defined. For the treatment of active ulcers, established oral schedules include 800 mg taken once daily at bedtime, or 300 mg taken four times a day. For ongoing maintenance therapy, the standard dose is generally 400 mg once daily, typically taken at bedtime. The total daily dose across all routes is officially restricted and should not normally exceed 2.4 g.

Specific procedural requirements govern the proper use of Histodil. The four-times-daily regimen is designed to be taken with meals and at bedtime. Conversely, when used for symptom prevention, the oral solution or tablet is often taken 30 minutes before eating a meal. Patients with impaired renal function require a mandated dose adjustment, often leading to a reduced schedule like 200 mg twice daily in severe cases. Parenteral administration of 200 mg doses requires administration slowly over at least five minutes. Treatment duration for active ulcers typically runs for a minimum of four weeks, extending to six weeks for gastric ulcers.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Histodil


Evidence for use in Stomach and Duodenal Ulcers

Histodil was evaluated in research exploring its use in stomach (gastric) and small intestine (duodenal) ulcers. The research in this area primarily includes controlled trials that examined how the medication influences outcomes related to physical discomfort and whether the research examined patterns related to ulcer status. These trials monitored patients over defined time intervals to observe how outcomes related to ulcer status changed and how symptom patterns evolved.

The findings from these clinical trials generally describe patterns observed in ulcer status, with a focus on outcomes related to patient-reported experiences of pain and discomfort. Research describes that the use of Histodil was associated with changes in outcomes capturing phases of heightened symptom activity when compared to placebo groups. However, the data also show patterns related to varying degrees of observed changes across different individuals and study designs.

Evidence for use in Severe Acid Reflux (GERD) and Erosive Esophagitis

Research has explored the role of Histodil in severe acid reflux (Gastroesophageal Reflux Disease or GERD), especially when the condition has caused damage to the lining of the food pipe (esophagus). The studies conducted for this indication were used in research exploring how symptoms change over time, focusing on outcomes related to changes in erosion status and patterns of change in the frequency and intensity of heartburn and regurgitation.

In trials focusing on episodes where symptoms become more noticeable, Histodil was evaluated in patients experiencing GERD. The evidence contributes to understanding symptom patterns by reporting on the frequency of symptoms and the measured time intervals over which erosions were observed to change. The findings describe patterns of changes in symptoms and changes in erosion status for some patients during the study periods.

Long-term Studies and Follow-up

Research has also explored outcomes reflecting daily functioning or activity level in patients taking Histodil over longer time frames, primarily in relation to the recurrence of ulcers. These studies monitored whether the initial positive changes were sustained. While research provides context but not individual predictions about the durability of the observed changes, long-term effects are not fully established for all possible uses and patient groups. Limited information is available for long-term outcomes, and follow-up durations were limited in many initial trials.

Key Studies & References

  1. Recurrent ulcer after successful treatment with cimetidine or antacid – PubMed – NIH (Long-term follow-up and recurrence patterns)

Frequently Asked Questions (FAQ)

Common questions about Histodil (FAQ)


Q: What kind of conditions is Histodil approved to treat?

A: According to official regulatory documents, Histodil is approved to treat several conditions. These indications typically include duodenal ulcers, gastric ulcers, severe acid reflux (Gastroesophageal Reflux Disease or GERD), and certain conditions characterized by excessive acid secretion.


Q: Why do some people say Histodil also helps with sleep?

A: Histodil is not officially approved for use as a sleep aid. However, official safety records list somnolence, the medical term for drowsiness, as a documented central nervous system side effect. This may be the reason some people perceive the medicine as having effects related to sleep.


Q: Does Histodil treat the cause of symptoms or just the symptoms themselves?

A: Histodil works by addressing a primary mechanism involved in digestive symptoms. Official product information describes its action as blocking histamine H2-receptors, which are critical sites for stimulating acid production in the stomach. This molecular blockade leads to a reduction in the secretion of gastric acid.


Q: How quickly should I expect Histodil to start working?

A: Official pharmacokinetic data, which describe how the drug moves through the body, indicate that the highest concentration of Histodil in the bloodstream is typically reached within 1 to 2 hours after it is taken by mouth.


Q: How long does the effect of Histodil typically last?

A: The official pharmacokinetic profile indicates the plasma elimination half-life (t1/2) of Histodil is approximately 2 hours. This time frame describes how quickly the medicine is processed and cleared by the body.


Q: Is it common to feel drowsy after taking Histodil?

A: Somnolence, the medical term for drowsiness, is listed among the documented central nervous system adverse reactions in the regulatory documentation for Histodil. This information is included in the official safety profile for the medicine.


Q: Can Histodil cause stomach upset or nausea?

A: Official safety records document nausea and vomiting as possible undesirable effects associated with Histodil. These effects are classified in the adverse reaction section of the official product information.


Q: Will Histodil still work if I take it with food?

A: Regulatory data on Histodil describes that taking the medicine with food may slightly decrease the speed at which it is absorbed into the body. However, the total amount of the drug that the body absorbs is generally not considered to be significantly affected.


Q: Is it okay to have a coffee or other caffeinated drinks while using Histodil?

A: Official drug interaction information notes that Histodil can affect the metabolism of certain substances, including caffeine. Because of this, taking Histodil may potentially lead to increased concentrations of caffeine in the body.


Q: What should I know about Histodil and alcohol?

A: Regulatory information indicates that Histodil may increase the concentration of alcohol present in the bloodstream. Official labeling contains a warning that using the medicine could potentially lead to increased effects from alcohol consumption.


Q: Is Histodil safe for older adults?

A: Official documentation on Histodil includes a warning regarding certain adverse effects, specifically reversible confusional states. These effects have been reported predominantly in older or severely ill patients.


Q: What happens if I miss a dose of Histodil?

A: Patient-use guidance describes that a missed dose of Histodil may be taken as soon as it is remembered. However, this is conditional: if it is nearly time for the next scheduled dose, the guidance recommends skipping the missed dose instead.


Q: Is Histodil considered an over-the-counter or prescription medicine?

A: Histodil is available in both over-the-counter (OTC) formulations and in higher-strength prescription forms. The specific strength and formulation used depend on the condition being addressed and regulatory guidelines.


Q: Are there any long-term side effects associated with Histodil use?

A: Official safety documents describe certain endocrine system effects that have been noted with Histodil, particularly following use at high doses or over long periods (defined as one month or longer). These specific effects include gynecomastia (enlargement of breast tissue).


Q: Do I need to take Histodil every day for it to work?

A: Official dosing regimens include protocols for both daily, continuous use, such as for maintenance therapy, and specific short-term active treatment periods. The required frequency of use depends on the established protocol for the condition being treated.


Q: Have there been any major safety warnings issued for Histodil?

A: The official FDA labeling for Histodil does not contain a Boxed Warning. This specific type of warning is reserved for drug products that carry the most serious risks.


Q: Does Histodil cause dry mouth or dry eyes?

A: Official adverse reaction lists for Histodil include xerostomia, which is the medical term for dry mouth, as a possible documented effect. Dry eyes are not explicitly noted in the common safety records.


Q: Can I take pain relievers like ibuprofen with Histodil?

A: Regulatory documents confirm that Histodil does not typically cause a significant drug interaction with non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen. This is because Histodil does not substantially affect the way these pain relievers are metabolized by the body.


Q: How does the body process and eliminate Histodil?

A: According to official pharmacokinetic information, Histodil is absorbed by the digestive system, is processed by the liver to a limited extent, and is then primarily removed from the body through renal (kidney) excretion.


Q: Is it true that Histodil can affect reaction time?

A: Due to the potential for adverse effects such as dizziness and somnolence (tiredness), official labeling advises that Histodil may impair functions related to reaction time. The official labeling contains a caution regarding the ability to drive or operate machinery.


Q: Is it normal to have a slight headache when starting Histodil?

A: Official safety records classify headache as a 'Common' adverse reaction associated with Histodil. In medical documentation, 'Common' means that this effect has been reported frequently in patients taking the medicine.


Q: Is there a risk of dependence or addiction with Histodil?

A: Official labeling for Histodil contains specific statements regarding its potential for abuse and dependence. According to these regulatory documents, there is no known risk of drug abuse or physical dependence associated with the medicine.


Q: Does Histodil have an inactive ingredient list I should check?

A: Official labeling includes a complete list of inactive ingredients, often called excipients, used in the various formulations of the medicine. These lists are included in the product information for patients to review.


Q: Is it safe to stop taking Histodil suddenly?

A: Patient guidance for Histodil used in short-term treatment protocols generally advises that abrupt discontinuation is permissible. However, if the medicine has been used for a longer period, official guidance recommends consulting a healthcare provider before making changes to the regimen.


Q: What is the FDA status or approval timeline for Histodil?

A: Regulatory records indicate that the active ingredient in Histodil, Cimetidine, was originally approved in the United States in the late 1970s. This information is part of the established history of the drug's regulatory status.


Q: Do studies show Histodil is effective across different age groups?

A: Clinical trials primarily focused on adults. Subgroup analyses of the clinical data did not identify differences in the medicine's effectiveness between younger and older adult subjects who were included in the studies.


Q: Why is Histodil sometimes combined with other medicines?

A: Histodil may be used in combination with other medicines as part of established medical protocols. For example, it is used alongside antibiotics in certain treatment regimens for the eradication of H. pylori bacteria.


Q: Does Histodil affect birth control pills?

A: Official regulatory documents describe that Histodil does not typically affect the effectiveness of oral contraceptives, commonly referred to as birth control pills.


Q: Is Histodil generally well-tolerated?

A: The safety summary contained in regulatory documents classifies the majority of reported adverse effects as Common or Uncommon. Based on this frequency data, the medicine is generally described as being tolerated in clinical settings.


Q: Does the effectiveness of Histodil decrease over time with repeated use?

A: Clinical trials have investigated how long the response lasts (durability) during established treatment periods. The evidence from these studies does not typically describe a significant decrease in the medicine's effectiveness with repeated use over time.


Q: Is it true that Histodil should not be taken with grapefruit juice?

A: Regulatory documents, including official drug interaction lists, indicate that there is no known clinically significant interaction between Histodil and grapefruit or grapefruit juice.


Q: Does Histodil have any known drug interactions with herbal supplements?

A: The official drug interaction profile notes the potential for Histodil to interact with various supplements, especially those that may influence CYP enzyme activity in the liver. This general caution applies to herbal supplements as well.

How should Histodil be stored and disposed of?

Histodil, like most medications, must be stored properly to maintain its potency and safety.

Storage

  • Keep Histodil tablets and other forms in the original container, tightly closed.
  • Store at controlled room temperature, generally between 68 F and 77 F (20 C and 25 C).
  • Protect the medication from moisture and excessive heat. Do not store in the bathroom or near a kitchen stove.
  • Keep Histodil, and all medicines, out of the reach of children and pets.

Disposal

  • The preferred method for disposing of expired or unused Histodil is through a drug take-back program or by using a mail-back disposal envelope available at pharmacies.
  • If a take-back option is not available, do not flush Histodil down the toilet. Dispose of it in your household trash after mixing the medication with an undesirable substance (like dirt or used coffee grounds) and placing the mixture in a sealed bag or container.
  • Scratch out all personal information on the prescription label before discarding the empty packaging.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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