Tadenan

Quick links to important sections

Tadenan

Selected form

Medically reviewed

Laura Arias

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 Tadenan

Quick Facts

  • Primary Active Ingredient: Extract of Prunus africana (African Plum Tree) bark.
  • Main Therapeutic Use: Treatment of lower urinary tract symptoms associated with Benign Prostatic Hyperplasia (BPH).
  • Drug Class: Phytotherapeutic agent (a medicine derived from a plant).

Tadenan is a phytotherapeutic medication primarily used to address certain urinary issues in men related to Benign Prostatic Hyperplasia (BPH), also known as an enlarged prostate gland. Its active pharmaceutical ingredient is a liposterolic extract derived from the bark of the African plum tree, scientifically named Prunus africana.

Standardized P. africanum bark extract is used to provide moderate improvements in urological symptoms. These improvements may include a reduction in nocturia (frequent nighttime urination), diminished residual urine volume, and an increase in peak urine flow rate.

The mechanism of action involves several pathways, including anti-inflammatory properties and the inhibition of certain growth factors that contribute to prostate cell proliferation. Tadenan is not used as a treatment for the underlying prostate enlargement itself, but rather as a means to alleviate the urinary symptoms associated with the condition.

Regulatory References

  1. TADENAN 50 mg, capsule molle - Notice patient - ANSM

What side effects are possible with Tadenan?

Possible Side Effects and Safety Information

The safety profile of Tadenan (liposterolic extract of Prunus africana) is primarily characterized by the official documentation of mild adverse reactions across specific organ systems. Regulatory reports generally classify these undesirable effects as rare or of unknown frequency, and they are typically transient.

Adverse Reaction Scope

The officially listed side effects primarily involve the Gastrointestinal Disorders system, including reactions such as nausea, diarrhea, constipation, and gastric pain. Other system-organ classes involved include Nervous System Disorders (e.g., dizziness and headache) and Immune System Disorders (e.g., hypersensitivity reactions). No specific reactions are explicitly classified as "Serious Adverse Reactions" in the available governmental regulatory monographs for this product.

Safety Restrictions and Population Considerations

Official labeling defines clear limits for use. The medicine is contraindicated in any individual with a known hypersensitivity to the active substance or its excipients. Furthermore, due to the drug's intended use and lack of safety data in other groups, it is contraindicated for use in children and adolescents under 18 years of age, and its use is considered not relevant for women, including those who are pregnant or lactating.

Clinical and Diagnostic Notes

A critical restriction noted in regulatory documents is that the medicine is only for the symptomatic management of Benign Prostatic Hyperplasia (BPH). Therefore, the diagnosis of prostate cancer must be formally excluded by a healthcare professional prior to initiating treatment.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory documentation for Tadenan, which contains the liposterolic extract of Prunus africana, is defined by the absence of reported human data concerning overdosage. According to European regulatory assessment reports and monographs, no case of overdosage with the active substance has been formally reported.

Consequently, specific clinical signs, symptoms, or life-threatening manifestations resulting from an overdose are not documented in the official prescribing information. Specific severity classifications or dose-related factors for overdose are also not listed in regulatory sources.

Required Emergency Actions

The governing regulatory bodies mandate a clear course of action in any suspected instance of excessive ingestion. Immediate medical attention must be sought, or emergency medical services must be contacted immediately, upon the confirmed or suspected ingestion of an excessive amount of Tadenan.

Management and Antidote Status

The officially documented management approach is limited to providing symptomatic and supportive treatment. This is the standard regulatory instruction, meaning any potential clinical manifestations that develop would be managed as they arise. Furthermore, regulatory labeling confirms that no specific antidote is known for the active ingredient. No specific monitoring protocols or population-based considerations regarding overdose severity are detailed in the official regulatory documentation.

Therapeutic Uses of Tadenan

What Tadenan Treats: Main Uses and Benefits

Tadenan is commonly used to help manage symptoms linked to organ-specific functional stress, particularly those associated with Benign Prostatic Hyperplasia (BPH). The medication is used to assist with urologic symptoms and may be part of symptomatic management in situations where functional stability becomes affected.


Addressing Symptoms that Interfere with Daily Functioning

This therapeutic domain is applied across domains where additional symptomatic support is needed when symptoms related to physical discomfort and urinary function create noticeable physiological strain. The medication is relevant for assisting with the symptom clusters commonly seen in BPH, such as weak urine flow and the feeling of incomplete bladder emptying. The medicine helps improve day-to-day comfort during symptomatic periods.

“It supports the patient during difficult episodes by easing the overall symptom load.”

Relieving Symptom Clusters Associated with Acute or Episodic Changes

Tadenan may assist with managing symptoms associated with acute or episodic changes that interfere with daily comfort, including frequent urination and nocturia (waking up to urinate). This is helpful in situations where these symptoms become more disruptive during flare-ups, offering supportive relief that helps patients cope more steadily with symptom fluctuations.

Quick Fact: Context for use in situations involving Physiological Strain The use of Tadenan is relevant in contexts marked by increased discomfort or tension associated with conditions involving episodic or fluctuating manifestations.

Regulatory References

  1. Health Canada Monograph on Pygeum

Eligibility and Restrictions for Use

Tadenan’s eligibility profile is strictly defined by regulatory documents, limiting use to a specific adult population and defining clear contraindications and prerequisites.

Populations Allowed to Use Tadenan

The medicine is documented for use in Adult Males aged 18 years and older, including the Elderly population. The established indication is specifically for men with lower urinary tract symptoms associated with Benign Prostatic Hyperplasia (BPH).

Use in women, including during pregnancy or lactation, is classified by regulatory authorities as not relevant given the indication is exclusively for a male-specific condition.

Who Must Not Use Tadenan (Contraindications)

Tadenan is formally contraindicated and must not be used in the following groups:

  • Children and adolescents under 18 years of age.
  • Patients with a known hypersensitivity or allergy to the active substance (Prunus africana extract) or to plants belonging to the Rosaceae family.

Eligibility Restrictions and Prerequisites

Eligibility is conditional upon medical assessment. The medicine must only be used after the diagnosis of prostate cancer has been formally excluded by a medical doctor. If a user experiences an acute worsening of symptoms such as fever, blood in the urine, painful urination, or urinary retention, continued use requires immediate medical consultation.

What should I know about interactions with other medicines?

The official regulatory profile for Tadenan, a phytotherapeutic agent derived from Prunus africana extract, is notable for the absence of specific, formally documented drug interactions with other medicinal products or substances. This position is based on evidence from clinical trials and case studies reviewed by government agencies, which have not established or reported significant pharmacokinetic or pharmacodynamic interactions.

Formal Interaction Status

Interaction Type Official Regulatory Documentation Status
Interacting Medicines/Categories None explicitly listed in formal regulatory interaction sections.
Metabolic or Transporter Effects No specific involvement with CYP enzymes or drug transporters (e.g., P-gp) is documented in official prescribing information.
Timing Requirements No mandatory rules for separating the administration of Tadenan from other medications are stated.

Regulatory Interaction Constraints

Official government monographs and assessment reports reflect that there are no explicit prohibited combinations due to interaction risk. The documentation also does not list specific constraints related to co-administration with food, alcohol, or herbal products in its dedicated interaction sections.

This lack of specific listings means the regulatory authorities have not defined any contraindications or warnings for Tadenan based on interactions with other products.

Mechanism of Action

The biological activity of the Prunus africana extract stems from its multi-target action on key pathways linked to functional lower urinary tract dynamics. The extract modulates these pathways primarily through three mechanistic domains.

Modulation of Prostatic Tissue Inflammation

The active components, including phytosterols, inhibit the 5-Lipoxygenase ( 5-LO) enzyme, which is critical for synthesizing inflammatory leukotrienes. This inhibition reduces local tissue edema and irritation, contributing to a reduction in dynamic pressure on the urethra and modulation of afferent signaling pathways.

Protection and Stabilization of Bladder Function

This mechanism focuses on preserving the physiological integrity of the detrusor muscle. By helping maintain the metabolic vitality of the bladder cells (e.g., through enzymes like Citrate Synthase), the extract supports sustained contractile strength and reduces muscle hypersensitivity. This physiological stabilization leads to preserved bladder contractility and an increase in voiding efficiency.

Dampening of Cellular Growth Signals

The extract's components, such as triterpenes, interfere with signaling from growth factors ( FGF/EGF) that promote the proliferation of prostatic stromal cells. This action contributes to modulating the rate of stromal cell accumulation within the tissue structure.

Dosage and Administration Information

How Tadenan is Used: Administration Guidelines

The administration of Tadenan (Extract of Prunus africana bark) is based on specific parameters for its use. The primary route of administration is oral. The medicine is supplied as a standardized extract, typically provided in solid oral forms, such as capsules or tablets.

The standard adult dosing regimen involves specific amounts. While the daily range for the standardized extract may span from 75 mg to 200 mg, the typical recommended daily dose is 100 mg. This total daily amount is generally administered in divided doses, commonly resulting in intake twice per day. The medication is generally taken with food or milk as part of the standard procedural conditions for administration.

Regarding the duration and patient group, Tadenan is intended for long-term use in the symptomatic management of the condition it addresses. Its use is restricted to adults and the elderly. There is no relevant use for children or adolescents under 18 years of age. The treatment does not require special preparation, such as dilution or shaking, prior to oral intake.

Recent Clinical Evidence

Clinical Research Evidence: Lower Urinary Tract Symptoms (LUTS) in BPH

This overview summarizes the available research evidence for Tadenan, which has been studied for its use regarding lower urinary tract symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH). The information comes from official sources and scientific literature that contributes to the medicine's clinical evaluation.

The main study designs used in research exploring how symptoms change over time include Randomized Controlled Trials (RCTs). In these trials, the extract of Prunus africana was studied for comparison against an inactive substance (placebo). These individual trials are included in larger summaries called systematic reviews and meta-analyses to examine the overall evidence landscape.


Endpoints Examined in Initial Trials

Research in this area has explored measuring changes in outcomes related to physical discomfort and urinary function. Studies examined how the condition evolved in the observed populations over defined time intervals, usually short-term.

The outcomes research examined included standardized symptom scores, such as the International Prostate Symptom Score (IPSS), which captures how patients reported their experience of symptoms. Researchers also monitored specific measurements of daily function, such as the total frequency of urination, particularly nocturia (waking up to urinate at night), Peak Urine Flow Rate (Qmax), and the volume of Post-Void Residual (PVR) urine left after voiding.

Studies reported measured patterns in standardized symptom scores and specific functional measures when the extract was compared to placebo. The evidence contributes to understanding symptom patterns over the period in which the patients was observed in the trials.


Research on Long-Term Use and Maintenance

The duration of follow-up in clinical trials is a key aspect of the evidence. Most high-quality studies were conducted during periods of increased symptom activity and were short-term, ranging from a few weeks to approximately four months. Because of this, the evidence is limited regarding the long-term patterns of use. Long-term effects and the durability of any measured changes are not fully established.


Evidence Gaps and Areas for Future Study

A primary concern among researchers is that the majority of the existing high-quality comparative data results apply only to the populations studied and the defined short-term follow-up durations. Furthermore, comparative evidence is lacking regarding direct comparisons between the Prunus africana extract and established conventional prescription treatments for BPH. Also, different trials sometimes use different methods for preparing or standardizing the extract, which means that the evidence quality varies across studies and can lead to results that were observed in some studies but not others, where overall certainty is characterized as low.


Study Populations: Focus of Clinical Trials

The research so far has focused on a very specific population: older adults diagnosed with symptomatic BPH. Crucially, these trials predominantly included patients whose symptoms were classified as mild to moderate. Therefore, results apply only to the populations studied, and data for certain groups remain insufficient, especially for those with more severe symptoms. Studies help show what has been observed so far, but the evidence does not determine whether an individual will respond similarly, as findings describe group patterns, not outcomes for an individual.

Key Studies & References

  1. Health Canada Monograph: Pygeum (Pygeum africanum)

Frequently Asked Questions (FAQ)

Common questions about Tadenan (FAQ)


Q: Is Tadenan considered an herbal remedy or a regulated drug?

A: Tadenan is classified by official health bodies as a phytotherapeutic agent or herbal medicinal product. This means it is derived from a plant, Prunus africana, but has gone through a regulatory process to be authorized for a specific therapeutic use. This regulatory status allows it to be distinguished from general, non-authorized dietary supplements.


Q: How is Tadenan different from taking a regular vitamin or supplement?

A: Unlike general vitamins or supplements, Tadenan is regulated as a herbal medicinal product for the symptomatic management of benign prostatic hyperplasia (BPH). Its authorization is based on clinical data that supports its use for the symptomatic relief of a specific health condition. This official regulatory status requires adherence to defined quality and safety standards.


Q: Does Tadenan actually shrink the prostate gland?

A: The official product information states that Tadenan is authorized only for the symptomatic management of issues related to BPH. It is explicitly not considered a treatment for the underlying prostate enlargement itself. The medication is intended to help manage related urinary symptoms, not to reduce the physical size of the gland.


Q: Does Tadenan treat the underlying cause of an enlarged prostate or just the symptoms?

A: The medication is authorized strictly for the symptomatic treatment of lower urinary tract issues associated with an enlarged prostate. According to official documents, it is not a treatment intended to address the underlying cause of the enlargement itself. Its purpose is focused on managing the bothersome urinary symptoms.


Q: Can Tadenan be used by people who do not have an enlarged prostate?

A: The authorized use of Tadenan is strictly restricted to men who have lower urinary tract symptoms associated with Benign Prostatic Hyperplasia (BPH). Official regulatory documents define eligibility based on this specific diagnosis. Use for other conditions or populations is outside of the product's established indication.


Q: Why is Tadenan sometimes mentioned alongside traditional or natural remedies?

A: Tadenan is classified as a phytotherapeutic agent or herbal medicinal product because its active ingredient is derived from the bark of the Prunus africana plant. This plant origin is why the medicine is sometimes discussed in the context of traditional or natural remedies. However, its use is governed by formal regulatory standards.


Q: Does Tadenan work differently than prescription alpha-blockers like Tamsulosin?

A: The mode of action for Tadenan is documented as a multi-target action that includes anti-inflammatory and anti-proliferative effects on prostatic tissue. While this mechanism is clearly defined in official product information, regulatory documents make no direct comparisons to how prescription medicines like alpha-blockers work.


Q: What happens if someone forgets to take a dose of Tadenan?

A: Official documentation for administration directions states that no specific statement is required for instructions on a missed dose. The full product information leaflet should be consulted.


Q: Do the positive effects of Tadenan continue after the officially recommended course of treatment is finished?

A: Evidence from clinical trials on this product is largely based on short-term follow-up periods. Because of this, the durability of any measured changes after a patient discontinues the medicine has not been fully established in the existing clinical trial evidence.


Q: What is the expected general duration of a typical treatment cycle with Tadenan?

A: The medicine is authorized by regulatory bodies for long-term use in the symptomatic management of BPH. Official documentation regarding the duration of use states that no specific cycle length is required to be listed on the product label.


Q: Does Tadenan have any known effects on blood pressure?

A: Based on the official product information, effects on the cardiovascular system, including changes in blood pressure, are not listed in the documented adverse reaction profiles. This means they are not formally recognized side effects in the regulatory documents.


Q: What are the signs of an allergic reaction related to Tadenan?

A: The official product documentation lists hypersensitivity reactions as a possible adverse effect. This type of reaction is included under the Immune System Disorders system-organ class. Consult the complete product information for a full description of possible unwanted effects.


Q: Is there a risk of long-term side effects from using Tadenan for many months?

A: The clinical evidence supporting the product's authorization comes mainly from studies conducted over short-term follow-up durations. Consequently, the data available on the risk of side effects from using the medicine for many months or years is limited.


Q: Can Tadenan affect how often someone needs to urinate at night?

A: Clinical trials for Tadenan monitored changes in nocturia (waking up to urinate at night) as a specific measurement endpoint. Studies have reported measured patterns of change in nocturia when the extract was compared to placebo.


Q: Is it safe to take Tadenan with over-the-counter pain relievers?

A: Official regulatory documents state that no specific constraints or mandatory rules for separating the administration of Tadenan from other medications are formally listed in the dedicated interaction sections.


Q: Can Tadenan be taken at the same time as other prescription medications for BPH?

A: Official documents state there are no explicit prohibited combinations due to interaction risk. The documentation also does not mandate specific rules for separating the administration of Tadenan from other prescription medications.


Q: Does Tadenan interact with any common blood thinning medications like warfarin?

A: Official regulatory documentation reflects that no specific drug interactions with other medicinal products, including anticoagulants like blood thinners, are formally documented or established. The labeling does not list any warnings regarding these specific interactions.


Q: Can people with severe liver or kidney problems use Tadenan?

A: The official regulatory information for this extract does not document specific dose adjustments or usage restrictions based on concurrent liver or kidney impairment. Information about special warnings or precautions related to organ function is not specified in the official documentation.


Q: Is Tadenan more effective for mild BPH symptoms or severe BPH symptoms?

A: Clinical trials supporting the product's profile primarily included patients whose symptoms were classified as mild to moderate. Data for patients with more severe symptoms is noted in the official assessment reports as being insufficient for making a comparison.


Q: Has the safety profile of Tadenan been studied over many years?

A: The majority of high-quality studies supporting the product's profile were conducted over short-term durations, typically a few weeks to a few months. Because of this, the evidence available on the safety profile of the extract over many years of use is limited.

How should Tadenan be stored and disposed of?

How to Store and Dispose of Tadenan?

The storage and disposal of Tadenan (Prunus africana extract) must strictly adhere to regulatory requirements to ensure product stability and safety.

Storage Requirement Official Regulatory Statement
Temperature Store at a temperature below 30°C or at controlled room temperature.
Protection Must be protected from light and excessive moisture to prevent degradation.
Container Keep the medicine in the original packaging to maintain integrity.
Handling Do not freeze the product; avoid areas of high heat and humidity.

For safety, Tadenan must be kept out of the sight and reach of children. Unused or expired Tadenan must be disposed of through an official drug take-back program. If a program is unavailable, follow the procedure of mixing the product with an unpalatable substance, sealing it in a container, and discarding it in the household trash. Do not dispose of this medicine in wastewater.

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

Available in countries:

Equivalent of Tadenan found in:

A-Z Index: