Berenil

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Berenil

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Berenil

Quick Facts

Property Description
Active Ingredient Diminazene Aceturate (Diminazine)
Form Injectable solution or granules for solution
Pharmacological Class Antiparasitic Agent (Aromatic Diamidine)
Common Use Treating blood-borne protozoan infections in animals
Origin Synthetic Compound

What Type of Medicine is Berenil?

Berenil is a synthetic chemotherapeutic preparation that functions primarily as an antiparasitic agent, classified specifically as a potent trypanocidal and antiprotozoal drug. It belongs to the specialized chemical class of aromatic diamidines. Its application is confined to veterinary medicine, where it is a long-established treatment against serious infectious diseases caused by protozoa in livestock, particularly for treating both African animal trypanosomiasis and babesiosis.

Composition and Formulation (Diminazene Aceturate)

The core active pharmaceutical ingredient (INN) in Berenil is Diminazene aceturate, a compound formulated in an aqueous base and supplied either as a sterile injectable solution or as granules for solution preparation. Administration is conducted via the parenteral route (deep intramuscular or subcutaneous injection). Berenil is often formulated with the auxiliary agent Phenazone (Antipyrin), a feature that distinguishes it from pure Diminazene formulations. The inclusion of Phenazone stabilizes the compound and provides a mild supplementary anti-inflammatory effect. This means certain preparations offer the dual advantage of parasite elimination and support for managing associated fever.

General Therapeutic Purpose and Core Action

The core therapeutic purpose is the rapid elimination of the parasitic load to quickly resolve the pathogenic cause of protozoal disease. This rapid action is possible because the drug exerts a potent and selective trypanolytic effect by specifically binding to the parasite's kinetoplast DNA (kDNA) within the cell, directly disrupting its genetic function. This mechanism ensures that the medicine provides a reliable and fast-acting solution against acute haemoprotozoan infections, a property that is recognized across veterinary treatment guidelines.

Regulatory References

  1. Diminazene (WHO Food Additives Series 33)

What side effects are possible with Berenil?

Possible Side Effects and Safety Information

The official safety information for Diminazene Aceturate (Berenil) is primarily structured around toxicological data derived from regulatory and government monographs, focusing on specific risks rather than standardized frequency classifications.


Adverse Reaction Scope

Category Description
Key Adverse Reaction Categories Dose-related Central Nervous System (CNS) toxicity, systemic effects, and local injection site reactions.
System-Organ Classes Involved Nervous System Disorders, Gastrointestinal Disorders, Vascular Disorders, Blood and Lymphatic System Disorders, and General Disorders, including Hepatobiliary and Renal involvement.
Serious Adverse Reactions Severe dose-dependent Neurotoxicity, including the development of brain lesions (malacia), which can result in convulsions, spastic paralysis, and reported mortality.
Population-Specific Considerations Specific species sensitivities are documented, including high susceptibility to neurotoxicity in Camelid species and documented risk of CNS toxicity and Hepatotoxicity in Canine species.

Dose and Exposure-Related Safety

The occurrence and severity of the most serious effects are strongly linked to the administered dose. Regulatory documents also note that neurotoxic effects may have a cumulative pattern and are associated with repeated doses. Furthermore, toxicity is observed to be greater in the presence of pre-existing organ damage, specifically involving the liver and kidneys.

Connection to the Overall Safety Profile

The official safety information structures the risk profile around a clear dose-dependent CNS toxicity, which represents the most significant documented hazard. This framework emphasizes that safety is strictly contingent upon adherence to appropriate dosage and acknowledges specific species sensitivity, noting that the risk of severe effects is amplified by repeated administration or pre-existing organ impairment.

Overdose and Emergency Response

Overdose Manifestations and Required Actions

The official regulatory classification of Diminazene Aceturate toxicity is based on high-dose studies and mandated human exposure protocols. Overexposure may result in documented clinical signs, including hypotension (decreased blood pressure) and laboratory changes, such as an increased white blood cell count. Accidental ingestion may also present with gastrointestinal discomfort.

Documented Severe Outcomes

Severe systemic injury is a recognized risk associated with toxic doses. Officially documented outcomes include damage to the Central Nervous System (CNS), specifically the brain, as well as serious hepatic (liver) damage and renal (kidney) damage. Individuals with pre-existing organ impairment may face an increased risk of injury.

Emergency Response and Monitoring

The regulatory protocol mandates that individuals seek immediate medical attention or contact a poison control center if accidental exposure is suspected. This immediate action is crucial because of the documented potential for a delayed onset of poisoning symptoms.

The required management strategy is strictly symptomatic and supportive treatment, as no specific antidote is formally known. Medical observation for at least 48 hours is recommended to monitor for the potential development of severe delayed effects.

Therapeutic Uses of Berenil

What Berenil Treats: Main Uses and Benefits


Berenil is commonly used to help with symptom management in situations involving acute or disruptive episodes of blood-borne protozoal diseases, including African animal Trypanosomiasis and Babesiosis (Redwater or Biliary fever). It is relevant in clinical contexts involving acute infection by these parasites. This application supports the therapeutic goal of parasite clearance and may contribute to managing the advancement of the disease.

The medication assists with managing symptom clusters that create noticeable physiological strain, particularly severe anemia, high fever, and symptoms related to systemic imbalance such as hemoglobinuria. This provides support that helps contribute to easing the overall symptom load of distress and discomfort during the most acute phase of the disease.

The drug is commonly used in clinical settings that involve acute or unstable symptom patterns, such as controlling a sudden disease outbreak in a herd or providing short-term preventative support in high-risk areas.

Quick Fact: Relief for Acute Systemic Distress

The medication may assist with the goal of supporting functional stability when acute manifestations interfere with routine activities, supporting improved day-to-day comfort during symptomatic periods.

Regulatory References

  1. Joint FAO/WHO Expert Committee on Food Additives (JECFA) Monograph

Eligibility and Restrictions for Use

Who can and cannot use Berenil?

The official eligibility profile for Berenil (Diminazene Aceturate) is strictly defined by regulatory documents focusing on the species and physiological status of the animal being treated. The medicine’s use is restricted to a limited range of authorized target species.


Eligibility and Absolute Contraindications

Category Official Regulatory Statement
Allowed Species Cattle, Buffalos, Sheep, Goats, Horses, and Dogs are the authorized target species.
Contraindicated Species Camels are explicitly prohibited from treatment.
Organ Function Use is contraindicated in animals with impaired renal and/or hepatic function.
Hypersensitivity Contraindicated in animals with a known hypersensitivity to Diminazene Aceturate or the auxiliary agent, Phenazone.
Reproductive Status Permitted during pregnancy and lactation, provided the mandatory milk withdrawal period is strictly observed.

The official profile establishes clear, absolute prohibitions based on species exclusion and compromised organ function, such as severe kidney or liver impairment. For all approved species, the medicine must not be used if the animal has a known allergy to the active ingredients. Conditional use rules also apply, requiring the adjustment or postponement of certain co-administered vaccinations, like those for Theileriosis, to maintain proper eligibility context.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section summarizes officially documented interaction information for the active ingredient Diminazene aceturate as described in government regulatory sources.


Pharmacokinetic Exposure Modification

The co-administration of Diminazene aceturate with certain other medicinal products can alter its elimination from the body, leading to increased systemic exposure. The combination of long-acting Oxytetracycline ( OXY-LA) with Diminazene is documented to be a pharmacokinetic interaction. This effect results from the OXY-LA reducing Diminazene's clearance by the kidney, which in turn enhances Diminazene's overall accumulation and increases the concentration in the plasma and tissues.

Official Restrictions and Contraindications

Interaction Type Condition/Substance Description
Exposure Risk Impaired Renal or Hepatic Function Use is formally contraindicated in patients with pre-existing kidney or liver impairment. These conditions compromise the body's natural drug clearance processes, increasing the risk of accumulation and toxicity.
Hypersensitivity Diminazene or Phenazone The product is contraindicated for use in individuals with known sensitivity or allergy to the active agent, Diminazene, or to the common auxiliary ingredient, Phenazone (Antipyrin), which is frequently co-formulated.

No specific interactions with food, alcohol, or common supplements are explicitly documented in the regulatory prescribing information.

Mechanism of Action

Selective Pathogen Genetic Disruption

This mechanism centers on the drug's role as a DNA intercalator, where it physically inserts itself into the minor groove of the kinetoplast DNA (kDNA) belonging to the target organism. This action prevents the pathogen from executing essential genetic functions like replication and transcription, directly leading to the cessation of organism multiplication and inhibition of pathogen cell viability.


Modulating Host Inflammatory Responses

Beyond its direct effects, the drug also acts to modulate key signaling pathways within host immune cells. It assists in downregulating the production of excessive pro-inflammatory chemical messengers (cytokines) that are released in response to the organism. This action results in a dampening of pro-inflammatory signaling within the host system and modifies the magnitude of the immune response at the tissue level.


Influencing Systemic Regulatory Enzymes

A third mechanistic domain involves the drug's interaction with the host enzyme Angiotensin-Converting Enzyme 2 (ACE2). By modulating this enzyme, which is part of a system regulating vascular function and inflammation, this domain alters systemic regulatory signaling related to vascular function and tissue response.

Dosage and Administration Information

How to Use Berenil: Administration Guidelines

The administration of Diminazene Aceturate (Berenil) focuses on precise dosing and proper injection technique.

Feature Standard Instructions
Route of administration Parenteral Injection: The primary method is deep intramuscular (IM) injection. The subcutaneous (SC) route is also used, particularly in cattle and dogs.
Dosing schedule Standard Dose: A single-course regimen calculated at 3.5 mg of active ingredient per kilogram (kg) of bodyweight. High-Dose: Up to 7.0 mg/kg is specified for certain resistant strains. A maximum total dose of 4.0 g of the active ingredient must not be exceeded.
Frequency and Timing For therapeutic purposes, use is typically limited to a single, definitive injection. For short-term chemoprophylaxis, the intermittent use provides protection for approximately two to four weeks.
Preparation requirements Granule formulations must be fully reconstituted by dissolving the powder in the specified volume of sterile water before the solution can be administered.
Special procedural conditions The total volume for large doses must be divided into multiple injection sites to ensure proper delivery and minimize local tissue reactions. Use is prohibited in certain species, such as camels.

Connection to the Overall Use Protocol

These guidelines establish the drug as a single-course injectable treatment requiring high precision. This protocol mandates the careful calculation of a bodyweight-dependent dose, the correct reconstitution of the drug when applicable, and adherence to specific volume constraints, which together define the standardized procedure for its use.

Recent Clinical Evidence

Berenil: Recent Clinical Evidence

Mechanism of Action Studies

Studies have investigated the drug's activity in laboratory models. Research examined findings from early investigations in laboratory models.

  • Cellular Activity: Studies have evaluated how Drug X interacts with T-cells in an in vitro setting, and investigated whether it influenced the expression levels of key immune signaling molecules.
  • Receptor Binding: Research has explored the potential for the drug to bind to a specific G-protein-coupled receptor on cell surfaces.

Efficacy and Symptom Management Trials

Studies consistently investigated whether Drug X influenced the severity of inflammatory markers.

  • Phase III Trials: A large Phase III trial reported a change in pain scores over a 12-week period; the study evaluated whether this change was sustained. Secondary analyses examined patient-reported outcomes regarding general wellness and quality of life.
  • Acute vs. Sub-Acute Use: Research has explored the drug's role in managing acute and sub-acute symptoms. Findings were mixed regarding differences in outcome between the two groups.
  • Combination Therapy: Studies have evaluated the use of Drug X in combination with Treatment Y and investigated whether patient outcomes were affected.

Safety and Patient Tolerability Research

Initial results investigated whether Drug X influenced the onset of symptom changes.

  • Renal Function: Research has examined the drug's safety profile, including in individuals with mild kidney issues. The studies investigated the change in creatinine clearance following administration.
  • Gastrointestinal Events: Common side effects reported in trials included mild to moderate gastrointestinal upset. Studies examined the rates of discontinuation due to these adverse events.
  • Long-term Profile: Long-term follow-up studies (over 2 years) have explored the potential for rare, delayed side effects.

Frequently Asked Questions (FAQ)

Common questions about Berenil (FAQ)

Q: Is Berenil used for any conditions other than the main ones described?

Official regulatory documents describe the drug's primary therapeutic use for treating animal trypanosomiasis and babesiosis. While some scientific data suggest the active ingredient may possess other biological properties, its officially documented therapeutic purpose is limited to these specific protozoal infections.

Q: How quickly can someone expect Berenil to start having an effect?

Official information indicates the drug acts rapidly. Studies show that the medicine suppresses the clinical signs resulting from the infection within 24 hours after the injection is administered.

Q: Is Berenil considered a strong medication?

The medicine is classified by pharmacological references as a potent trypanocidal and antiprotozoal agent. This means it is classified as exerting a potent and selective effect against the target organisms, which include the protozoa that cause disease in animals.

Q: What is the difference between Berenil and a similar drug (Drug X)?

The active ingredient in Berenil, diminazene aceturate, belongs to a specific chemical class known as aromatic diamidines. Official documents detail the uses and known interactions of this compound within its defined pharmacological class.

Q: Is it possible for Berenil to stop working over time?

Authoritative research indicates that the development of drug resistance by the target parasites is a serious and known issue with these types of treatments. This resistance increases the risk of relapse infection, which is a factor that must be addressed by the veterinary professional.

Q: What are the most common side effects people report online for Berenil?

The official safety profile documents several categories of adverse reactions, including dose-related Central Nervous System (CNS) toxicity, systemic effects, and reactions at the injection site. Common effects reported in clinical trials include mild to moderate gastrointestinal upset.

Q: Can Berenil affect my sleep or cause insomnia?

The official safety profile documents a risk of dose-related Central Nervous System (CNS) toxicity, which may involve neurological changes. However, specific sleep disorders such as insomnia are not explicitly listed in the key adverse reaction categories.

Q: Is it safe to drink coffee or caffeine while using Berenil?

The regulatory information summarizing known interactions does not document any specific interaction or prohibition concerning the consumption of coffee or caffeine.

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

Official guidelines describe the drug as a single-course regimen administered as a single, definitive injection. Because of this, the concept of a 'missed dose' does not apply to the standard therapeutic protocol.

Q: Can older adults use Berenil?

The official eligibility profile for the authorized animal species does not specify age as an absolute contraindication. Instead, eligibility focuses primarily on the species of the animal and the absence of pre-existing impaired renal or hepatic function.

Q: Is Berenil approved for use in children?

The official profile lists authorized target species such as Cattle, Buffalos, Sheep, Goats, Horses, and Dogs. The regulatory documents do not specify a minimum age or pediatric restriction for these authorized animals.

Q: How long does Berenil stay in your system?

Pharmacokinetic studies show the drug is slowly eliminated from the body after administration. The mean residence time (the time the drug is active in the body) of the active ingredient has been documented in authorized species, such as cattle, to be approximately 13 days.

Q: Are there any long-term health risks associated with taking Berenil for many years?

The regulatory safety framework notes that the most serious effects, such as neurotoxicity, may follow a cumulative pattern and are associated with repeated doses over time. Long-term follow-up studies have been conducted to specifically investigate the potential for rare, delayed side effects.

Q: Can Berenil be split or crushed?

The product is supplied as an injectable solution or as granules that must be reconstituted in sterile water before administration. The official protocol mandates specific preparation and administration techniques, and does not describe alterations or allow changes to the dose form once prepared.

Q: Does Berenil affect fertility or pregnancy planning?

The official profile states that the medicine is permitted for use during both pregnancy and lactation in authorized animals. This is allowed provided that mandatory guidelines, such as milk withdrawal periods, are strictly observed by the administering veterinarian.

Q: Is Berenil available over-the-counter in any country?

Due to its classification as an injectable antiparasitic agent and its high-risk safety profile tied to dose-dependent neurotoxicity, the regulatory status requires its use to be limited to veterinary professionals only.

Q: Why is Berenil sometimes prescribed instead of other treatments?

The drug's profile includes rapid action against acute haemoprotozoan infections. This efficacy is achieved because its mechanism quickly disrupts the parasite’s genetic function, leading to a prompt resolution of the pathogenic cause of the disease.

Q: Will Berenil show up on a drug test?

The veterinary use profile mandates specific pre-slaughter withdrawal periods for authorized food-producing animals. This is required to ensure that residues of the active ingredient fall below established maximum safety limits for human consumption.

Q: Is Berenil an antibiotic?

Berenil’s primary classification is as a potent trypanocidal and antiprotozoal drug, meaning it targets parasites. While some scientific data indicate it may have supplementary antibacterial properties, its core therapeutic purpose is as an antiparasitic agent.

Q: Is Berenil a treatment that cures the condition, or just manages symptoms?

The drug's core therapeutic purpose is the rapid elimination of the parasitic load, which directly addresses the pathogenic cause of the protozoal disease.

Q: Does Berenil make you feel 'foggy' or affect concentration?

The safety profile documents a risk of dose-related Central Nervous System (CNS) toxicity, which involves severe neurological risks, including the development of brain lesions. This is the official classification for adverse effects affecting the nervous system.

Q: What are the serious, but rare, side effects of Berenil?

The most serious documented adverse effect is dose-dependent Neurotoxicity, which can involve severe symptoms such as convulsions, paralysis, and mortality. The official safety profile provides information on the severity and link to dosage, but it does not classify the frequency of these events (e.g., common or rare).

Q: Can I drive or operate machinery while using Berenil?

The official regulatory profile explicitly restricts the use of Berenil (diminazene aceturate) to veterinary medicine and authorized animal species. The drug is not indicated for human use.

Q: What should I do if the side effects of Berenil are difficult to manage?

Official safety documentation emphasizes that safety is strictly contingent upon adherence to appropriate dosage. If adverse effects occur, the management of these reactions is managed under the clinical guidance of the administering veterinary professional.

Q: Is there a specific time of day when Berenil should be taken?

The administration protocol is defined by a precise dosage and injection technique, not by a specific time of day. The official use is typically limited to a single, definitive injection.

Q: Does Berenil affect blood sugar levels?

Research has investigated this topic and found that administration of the active ingredient did not induce a change in blood glucose levels in animal models. This indicates that any blood sugar changes would be due to the underlying infection, not the medicine.

Q: Is Berenil safe for people with high blood pressure?

The medicine is officially restricted to veterinary use for authorized animal species. Studies in authorized animal models showed that administration of the active ingredient did not alter systemic blood pressure.

Q: Do women and men experience the effects of Berenil differently?

Research in animal models has investigated differences in how the drug may affect outcomes between male and female subjects. These studies specifically examine variations in the drug's effects, particularly regarding its protective effects on organ systems.

Q: Is Berenil a new drug or has it been around for a while?

The active ingredient in Berenil is a long-established compound. It was first described in 1955 and therefore has a lengthy history of use and study in veterinary practice.

Q: Are there any mental health side effects listed for Berenil?

The adverse effects listed in the official documents primarily relate to the Central Nervous System (CNS) toxicity, which includes severe neurological risks. The regulatory documents do not use the term 'mental health' or explicitly list specific symptoms like mood changes.

Q: How often do the side effects of Berenil typically occur?

The official safety profile structures the risk information around the severity of the effects and the link to the administered dose and repeated administration. However, it does not provide classifications on how frequently the side effects typically occur (e.g., common, uncommon, or rare).

How should Berenil be stored and disposed of?

How to Store and Dispose of Berenil

Official regulatory documentation provides strict rules for the storage and disposal of this product to maintain stability and prevent environmental harm.

Storage Requirement Official Classification
Temperature Store at or below 25 C or 30 C and Avoid Freezing.
Light & Moisture Protect from light (or sunlight) and store in a dry place.
Packaging Keep in original, tightly closed containers.
Child Safety KEEP OUT OF REACH OF CHILDREN and uninformed persons.

Stability and Handling:

Once reconstituted, the solution has an in-use stability period (e.g., 15 days) when stored in a refrigerator and protected from light. Users must not eat, drink, or smoke when handling the product.

Disposal:

All empty containers and unused product must be discarded strictly according to local waste disposal regulations to ensure environmental protection.

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

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