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Anastrozol Teva

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Anastrozol Teva

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Medically reviewed

Marina Burgos

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.

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Overview of Anastrozol Teva

Quick Facts

Property Description
Active ingredient Anastrozole (INN)
Form Film-coated tablet
Pharmacological class Aromatase Inhibitor (AI)
General purpose Anti-estrogenic effect / Hormone suppression
Origin Synthetic (Nonsteroidal Triazole Compound)

What Type of Medicine is Anastrozol Teva?

Anastrozol Teva is a synthetic pharmaceutical preparation containing the active ingredient Anastrozole (INN), delivered as a prescription-only film-coated tablet designed for oral use. It is broadly categorized as an antineoplastic agent and belongs to the pharmacological class of aromatase inhibitors (AIs), specifically the nonsteroidal triazole compound type. This classification reflects its specialized mechanism.

Active Ingredient and Primary Purpose

The drug’s core active ingredient, Anastrozole, is a single active substance product developed to achieve a potent anti-estrogenic effect in postmenopausal women. Its general purpose is achieved by selectively and potently blocking the aromatase enzyme (CYP19A1). This enzyme is naturally responsible for estrogen biosynthesis—the conversion of precursor androgens into circulating estrogen in peripheral tissues. By inhibiting the enzyme, Anastrozol Teva significantly lowers the amount of circulating estrogen in the body, which is the foundational therapeutic objective. The medication is recognized for providing sustained hormonal suppression.

How Anastrozole Differs from Other Therapies

Anastrozole is differentiated within endocrine therapy by its classification as a nonsteroidal AI. This means it achieves its effect through a competitive and reversible binding mechanism, unlike certain steroidal AIs which act as irreversible inhibitors. This mechanism is crucial for achieving high specificity in estrogen biosynthesis inhibition. Its action is also distinct from that of earlier hormone-targeting agents, such as selective estrogen receptor modulators (SERMs), which block estrogen receptors on cells instead of reducing the overall supply of estrogen. The specific oral film-coated tablet formulation, typical of the Teva product, ensures consistent systemic delivery of the triazole compound.

Regulatory References

  1. U.S. National Library of Medicine
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What side effects are possible with Anastrozol Teva?

Possible side effects and safety information

Regulatory documents classify the possible side effects and safety characteristics of Anastrozol Teva (anastrozole) based on the body systems affected and their reported frequency. The safety profile is heavily characterized by effects related to estrogen deprivation.

Frequency-Classified Adverse Reactions

The frequency categories used in official labeling define the likelihood of adverse reactions, ranging from Very Common (occurring in 1 in 10 patients or more) to Very Rare (occurring in less than 1 in 10,000 patients).

Classification Examples of Documented Adverse Reactions
Very Common Hot flushes (Vasodilatation), Asthenia (Fatigue), Headache, Arthralgia (Joint pain/stiffness), Nausea, Osteoporosis.
Common Vomiting, Diarrhoea, Somnolence, Hypercholesterolaemia, Alopecia (Hair thinning), Carpal Tunnel Syndrome, Hypertension.
Uncommon to Very Rare Hypercalcaemia, Hepatitis, Erythema multiforme, Stevens-Johnson Syndrome, Angioedema.

System-Organ Class Focus

Adverse reactions are formally grouped by the following systems in regulatory data: Musculoskeletal and Connective Tissue Disorders (including pain and fractures), Vascular Disorders (e.g., hot flushes), Metabolism and Nutrition Disorders (e.g., high cholesterol), and Hepatobiliary Disorders.

Serious Safety Considerations

The label documents specific serious adverse reactions. These include a risk of bone fractures and osteoporosis associated with long-term decreases in bone mineral density. An increased incidence of ischemic cardiovascular events has also been reported in women with pre-existing ischemic heart disease. The very rare occurrence of severe cutaneous reactions (e.g., Stevens-Johnson Syndrome) is also documented.

Population and Contextual Safety Notes

Anastrozol Teva is formally contraindicated in premenopausal women and during pregnancy or lactation, based on official regulatory constraints. The label advises caution when used in patients with pre-existing hepatic impairment.

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Overdose and Emergency Response

Overdose and when to seek help — Official Regulatory Information for Anastrozol Teva

Overdose Scope

Domain Official Regulatory Statement
Documented Overdose Presentations Clinical experience with acute accidental overdosage in humans is limited, and specific symptoms resulting from high-dose ingestion are not established in regulatory documents.
Physiological systems affected No specific physiological systems are officially described as being characteristically affected following an acute overdose.
Dose-related or exposure-related factors The single dose that would result in life-threatening symptoms has not been established.
Population-specific overdose notes No specific population considerations related to overdose severity or management are documented in the official overdose sections.
Emergency-response statements Management of overdose must be symptomatic and supportive. Standard procedures, including frequent monitoring of vital signs and close observation, are considered. Inducing vomiting may be considered if the patient is conscious.
When immediate medical help is required Immediate medical attention is required. Contact a poison control center or emergency services immediately following a suspected overdosage.

Overdose Classifications (High-Level)

Classification Official Regulatory Statement
Severity classification Not formally classified due to limited data; the regulatory focus is on life support and symptomatic care.
Regulatory basis Based on official Summary of Product Characteristics (SmPC) and FDA Prescribing Information.
Overdose-context constraints No specific antidote for anastrozole overdosage is known.

Resulting Overdose Structure

Official overdose statements:

  • Clinical experience is limited, and specific symptoms of acute, high-dose ingestion are not established in regulatory documentation.
  • Immediate medical attention is required; contact a poison control center or emergency services immediately.
  • Treatment is officially designated as symptomatic and supportive, including frequent monitoring of vital signs and close observation.
  • No specific antidote is known for Anastrozole overdosage.

Connection to the overall overdose profile (2–4 sentences): The regulatory profile is characterized by the absence of documented specific clinical manifestations following acute high-dose exposure. This requires immediate contact with emergency services and the prioritization of standard procedures for overdose management, focusing on continuous supportive care and monitoring due to the lack of a known specific antidote.

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Therapeutic Uses of Anastrozol Teva

The medication is a targeted endocrine therapy generally used in postmenopausal women for managing hormone receptor-positive conditions, which may involve recurrent or fluctuating manifestations. This is applied in addressing conditions presenting with systemic or localized discomfort.

Adjuvant Therapy to Prevent Recurrence

This application is commonly used after initial treatments, such as surgery, for managing the risk of relapse in early-stage breast cancer. The primary therapeutic benefit includes a reduction in the chance of cancer returning. This contributes to improved comfort during periods of heightened symptoms.

The core therapeutic indications include early-stage HR+ breast cancer in the adjuvant setting; first-line management of HR+ or HR-unknown locally advanced or metastatic breast cancer; and applied in situations after progression on prior hormone therapy.

“It supports patients during difficult episodes by easing distress related to the threat of recurrence and disease progression.”

Management of Advanced Malignancy and Risk Reduction

Anastrozol Teva is indicated for locally advanced or metastatic breast cancer to manage the condition where symptoms may intensify temporarily. The benefit is applied in addressing advanced stages by supporting disease management, and may help with maintaining a sense of stability when symptoms are more noticeable. Furthermore, this medication is considered relevant for chemoprevention in high-risk women who do not currently have breast cancer, where it may assist with lowering the overall probability of developing a new primary breast cancer in the future.


Quick Fact: Relief for Disease Progression Risk Anastrozol Teva helps address symptoms that interfere with daily functioning by providing long-term supportive management, particularly in scenarios involving the risk of relapse and advanced spread.

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Eligibility and Restrictions for Use

Who Can and Cannot Use Anastrozol Teva?

Anastrozol Teva's eligibility is strictly defined by regulatory bodies, focusing primarily on hormonal status and pre-existing conditions.

Populations Allowed and Restricted

Classification Population Group Regulatory Status
Approved Population Postmenopausal women Use Established
Use with Caution Patients with pre-existing hepatic or renal impairment Conditional Use
Not Recommended Children and adolescents Efficacy Not Established

Absolute Contraindications

The medicine is prohibited for use in the following populations, as stated in official labeling:

  • Premenopausal Women: The drug is not indicated for women who have not gone through menopause.
  • Pregnancy and Lactation: Use is strictly forbidden during pregnancy and while breastfeeding.
  • Hypersensitivity: Patients with known allergy to the active ingredient (anastrozole) or any excipient in the tablet must not use the medication.
  • Metabolic Disorders: Individuals with rare hereditary problems such as galactose intolerance or glucose-galactose malabsorption should not take this product.

Eligibility criteria are also affected by the severity of certain conditions; for instance, the medicine is contraindicated in some regions for patients with severe renal or moderate to severe hepatic disease.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

Interaction scope

Category Official Regulatory Information (Anastrozole)
Medicinal product categories with documented interactions Estrogen-containing therapies (e.g., estrogen replacement products). Other hormonal therapies (specifically Selective Estrogen Receptor Modulators).
Specific interacting medicines (if explicitly listed) Tamoxifen. Warfarin (Noted for absence of clinically significant interaction).
Mechanistic basis of interactions (only if stated in label) Pharmacodynamic interaction (Estrogen therapies nullify anti-estrogenic effect). Pharmacokinetic interaction (Tamoxifen reduces Anastrozole plasma concentration/exposure).
Timing-based interaction rules (if applicable) None documented for timing separation with food or co-administered drugs.
Population-specific interaction notes (if applicable) No specific interaction cautions are documented as being heightened in patients with hepatic or renal impairment compared to the general population.
Interaction-related restrictions Do not co-administer with estrogen-containing therapies. Co-administration with Tamoxifen should be avoided.

Interaction Classifications (High-Level)

Category Classification Details (Strictly Regulatory)
Interaction severity classification (as defined in official documents) Contraindicated (Estrogen-containing therapies) and Avoid Combination (Tamoxifen).
Regulatory basis (EMA / FDA / etc.) FDA Prescribing Information, European Summary of Product Characteristics (SmPC).
Interaction-context constraints (as defined in official documents) Food has no clinically significant effect on the extent of absorption, removing a potential administration constraint.

Resulting interaction structure

The regulatory profile strictly contraindicates co-administration with estrogen-containing therapies because this combination would nullify the anti-estrogenic effect. Co-administration with Tamoxifen is advised to be avoided due to a pharmacokinetic interaction where Tamoxifen reduces Anastrozole's plasma concentration by approximately 27%. While in vitro data show Anastrozole is a weak inhibitor of Cytochrome P450 enzymes (e.g., CYP 3A4), regulatory labeling states that co-administration with other medicines is unlikely to result in clinically significant inhibition. No mandatory timing rules or restrictions are documented for administration with food or most other medicines.

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Mechanism of Action

How Anastrozol Teva Works: Mechanism of Action

Selective Aromatase Enzyme Blockade

Anastrozole acts as a selective competitive inhibitor of the aromatase enzyme (CYP19A1), which is the molecular target that catalyzes the final and essential step of estrogen synthesis in the body. This specific interaction involves a reversible binding at the enzyme's active site, preventing the precursor hormones from being converted, thereby establishing the initial molecular effect of the medication.


Profound Systemic Estrogen Deprivation

Inhibiting the aromatase enzyme, the molecule interferes with the conversion of androgens to estrogens (e.g., testosterone to estradiol) in peripheral tissues, which are the main non-gonadal sources of estrogen. This specific pathway blockade leads to the mechanistic cascade's core physiological consequence: systemic estrogen deprivation, leading to a profound reduction in circulating serum estrogen levels.


Mechanistic Constraint in Premenopausal Physiology

While the drug inhibits peripheral aromatase, its mechanism is physiologically constrained in the presence of an actively functioning ovary. Because the ovarian source of estrogen is dominant and independent of peripheral aromatase, the high gonadal estrogen output overrides the effect of peripheral aromatase inhibition.

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Dosage and Administration Information

Anastrozol Teva is administered solely by the oral route as a 1 mg film-coated tablet. This 1 mg dose is the standard regimen recommended for all approved adult indications in postmenopausal women. Patients are directed to take one tablet once daily.

Administration Conditions and Timing

The standard usage instructions establish that the tablet may be taken with or without food, providing flexibility for daily scheduling. To maintain stable systemic levels, it is recommended to take the medication at approximately the same time each day. The tablet must be swallowed whole and should not be crushed or split. If a daily dose is missed, patients should skip the missed dose and take the next one at the regularly scheduled time; a double dose must be avoided.

Duration of Use and Population Rules

The duration of use is defined by the clinical context. For use in the adjuvant setting, treatment is typically continued for a period of five years. For advanced or metastatic disease, administration is continuous and maintained until clinical criteria indicate disease progression.

General medical guidelines state that no dose adjustment is required for older adults or patients presenting with mild to moderate renal or hepatic impairment. The use of this medicine is not recommended in premenopausal women or pediatric patients, as the labeled instructions restrict use to the postmenopausal population.

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Recent Clinical Evidence

Research evidence / Overview of Studies for Anastrozole (Anastrozol Teva)


Evidence for Adjuvant Therapy in Early-Stage Breast Cancer

Research explored anastrozole in the context of adjuvant therapy—post-surgery treatment—for early-stage breast cancer in postmenopausal women. The primary evidence stems from large-scale Randomized Controlled Trials (RCTs) that compared anastrozole against tamoxifen. Studies monitored endpoints like Disease-Free Survival and Time to Recurrence, with research groups reporting different patterns of measurements between the anastrozole and tamoxifen arms, particularly within the hormone receptor-positive patient subgroup.

Extended follow-up data from these large trials, extending to ten years or more, allow researchers to monitor the sustained patterns of Disease-Free Survival after the treatment has concluded. Researchers also examined the incidence of a new cancer appearing in the opposite breast (Contralateral Breast Cancer), with studies reporting distinct patterns between the research groups.


Evidence for Managing Advanced or Metastatic Disease

Anastrozole was studied for use as a first-line treatment for managing advanced (metastatic) breast cancer in postmenopausal women with hormone receptor-positive disease. Trials compared anastrozole to tamoxifen, focusing on measurements like the time until the cancer continued growing (Time to Progression, or TTP) and the proportion of women whose cancer shrank (Objective Response Rate, or ORR, which measures the rate of tumor size reduction).

Findings related to Overall Survival in this advanced setting generally did not report a statistically significant difference between the two treatments, often due to patients switching therapies after disease progression.


Evidence for Breast Cancer Risk Reduction (Chemoprevention)

Anastrozole was evaluated in research exploring chemoprevention in postmenopausal women considered to be at high risk. The foundational evidence comes from a large, randomized, double-blind trial that compared anastrozole against a placebo (an inactive dummy pill). Studies monitored the primary outcome of incidence of breast cancer (including invasive cancer and DCIS). Studies reported different occurrence patterns between the anastrozole group and the placebo group over the study period, particularly for cancers that were estrogen receptor-positive.

Follow-up data beyond the five years of treatment provide insight into the persistence of the observed patterns in cancer incidence. Comparative evidence for the overall patterns related to breast cancer mortality (death) in the chemoprevention setting is not fully established and data are still emerging with continued long-term observation.

Key Studies & References

  1. Public Assessment Report Scientific discussion Anastrozol Accord 1 mg, film-coated tablets (EMA/EU regulatory review)
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Frequently Asked Questions (FAQ)

Common questions about Anastrozol Teva (FAQ)


Q: Does Anastrozol Teva cause weight gain?

Studies and official information indicate that weight gain has been reported as a side effect. According to regulatory data, this is generally considered a less common adverse reaction, occurring in roughly 1% to 10% of patients in certain trials.


Q: Can men take Anastrozol Teva?

Official regulatory documents state that Anastrozol Teva is FDA-approved only for use in postmenopausal women to treat specific types of breast cancer. The use of this medicine in men is not part of the standard approved regulatory indication.


Q: Is Anastrozol Teva a chemotherapy drug?

Regulatory documents classify Anastrozol Teva as an antineoplastic agent and an Aromatase Inhibitor. It is a form of hormone therapy that works by reducing estrogen levels, and is not typically classified as a cytotoxic chemotherapy drug.


Q: What is the difference between Anastrozol Teva and letrozole?

Anastrozol Teva (anastrozole) and letrozole both belong to the Aromatase Inhibitor class and function similarly by lowering estrogen levels in the body. Differences exist in their specific chemical structure, and while both have been extensively studied, official documents focus on describing the drug's own profile rather than direct comparison data.


Q: Will Anastrozol Teva affect my mood?

Regulatory data lists mood disturbances and depression among the documented side effects. Mood changes were reported in a subset of patients during the clinical trials that examined the drug.


Q: Does Anastrozol Teva interact with common antidepressants?

Official regulatory checkers have not identified known interactions between anastrozole and certain common antidepressants. The product information advises patients to inform their healthcare provider about all medicines being taken.


Q: Can Anastrozol Teva be used with pain relievers like ibuprofen?

Regulatory review and interaction checkers indicate no direct interaction has been documented between anastrozole and ibuprofen. As with any co-administered medicine, official guidance indicates that concurrent use should be discussed with a healthcare provider, especially concerning the general risks associated with medicines like ibuprofen.


Q: What if I'm using herbal remedies with Anastrozol Teva?

Official guidance documents state that herbal remedies or supplements intended for menopausal symptoms are often restricted. This is because they may contain estrogen-like ingredients that could potentially counteract the intended effect of Anastrozol Teva.


Q: Does taking Anastrozol Teva require any special diet changes?

The official product information states that the tablet can be taken with or without food, as food does not significantly affect how the medicine is absorbed. While there are no required diet changes in the label, some patient guidance materials describe lifestyle adjustments, such as limiting caffeine, to potentially help manage side effects like hot flashes.


Q: Is it okay to drink coffee while taking Anastrozol Teva?

The official drug label does not prohibit drinking coffee. However, patient guidance documents sometimes suggest avoiding caffeine intake to potentially help reduce the frequency or severity of hot flashes, which is a very common side effect of the medicine.


Q: Are there any limitations on driving while using Anastrozol Teva?

The official product information advises caution because some patients may experience side effects such as fatigue or somnolence (drowsiness). If these effects occur, they may affect an individual's ability to drive or operate machinery safely.


Q: What are the possible vision-related side effects of Anastrozol Teva?

Regulatory safety data reports blurred vision as a potential side effect. Additionally, cataracts (clouding of the lens in the eye) have also been reported in patients during the course of clinical trials with the active ingredient.


Q: Is Anastrozol Teva a controlled substance?

According to official regulatory classifications from bodies like the DEA, the active ingredient, anastrozole, is not classified as a controlled substance.


Q: Is it necessary to have bone density scans while taking Anastrozol Teva?

Due to the risk of bone loss and osteoporosis associated with the medicine, the FDA label describes that healthcare providers should consider bone mineral density monitoring in patients treated with the medicine.


Q: Is it safe to get a flu shot while taking Anastrozol Teva?

Official regulatory reviews show that anastrozole is not known to interact with any vaccines or immunizations. The product instructions indicate that patients should consult with a physician regarding any vaccination during treatment.


Q: Can I stop taking Anastrozol Teva if I feel better?

The duration of treatment is determined by the treating physician for a specific period or until disease progression. The medication should not be discontinued unless instructed by a qualified healthcare professional.


Q: Is Anastrozol Teva used for conditions other than breast cancer?

Official documents state that Anastrozol Teva is only approved by the FDA for treating specific types of breast cancer in postmenopausal women. The regulatory indication does not cover other conditions.


Q: Can Anastrozol Teva affect my sense of taste?

Regulatory safety data includes reports of sensory disturbances as a side effect. Specifically, this may include taste perversion (an altered sense of taste) or taste loss (dysgeusia).


Q: Can I take Anastrozol Teva if I have high blood pressure?

Hypertension (high blood pressure) is listed as a common side effect of anastrozole in official documents. Official information includes a warning regarding the use of the medicine in patients with pre-existing cardiovascular conditions, including hypertension. The medicine is not listed as an absolute contraindication for mild hypertension.


Q: Is it common to have trouble sleeping when on Anastrozol Teva?

Official regulatory data lists somnolence (drowsiness or sleepiness) as a common side effect of Anastrozol Teva. While difficulty falling asleep (insomnia) is not always specifically listed, somnolence is an effect related to central nervous system activity.


Q: Can Anastrozol Teva cause stomach upset?

Regulatory documents report nausea and vomiting as common to very common side effects of the medicine. These specific reactions are part of the gastrointestinal effects observed in regulatory data.


Q: Does Anastrozol Teva affect liver function?

Regulatory documents report hepatitis (liver inflammation) as an uncommon to very rare side effect. Official product information includes a warning that caution should be exercised when the medicine is used in patients with pre-existing hepatic impairment (liver problems).


Q: Can Anastrozol Teva interact with blood thinning medications?

Official regulatory labeling specifically notes that there is an absence of a clinically significant interaction between anastrozole and warfarin, a common blood thinner. However, the regulatory profile does not address the broader category of all blood thinning medications.


Q: What are the signs of a serious reaction to Anastrozol Teva?

Official patient information often describes the signs to watch for. Symptoms may include a severe rash or blistering (indicating a severe cutaneous reaction) or experiencing chest pain or shortness of breath (indicating an ischemic cardiovascular event). The appearance of these signs indicates a need for immediate medical review.


Q: What types of food or drinks should be avoided with Anastrozol Teva?

The medicine can be taken with or without food, as food does not significantly affect absorption. However, to help manage side effects like hot flashes, patient guidance may suggest limiting the intake of caffeine and alcohol.


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How should Anastrozol Teva be stored and disposed of?

How to Store and Dispose of Anastrozol Teva?

The storage and disposal of Anastrozol Teva tablets must adhere strictly to regulatory conditions to maintain product stability and ensure safety.


Storage Requirements

Condition Regulatory Specification
Temperature Store at Controlled Room Temperature (20°C to 25°C / 68°F to 77°F). Brief excursions up to 30°C are permitted.
Protection Keep in a tight container and store in a dry place. The product must not be frozen and must be protected from excessive heat and moisture.
Child Safety The medicine must be kept out of the sight and reach of children.

Disposal Instructions

Official guidelines recommend disposing of unused or expired tablets through a drug take-back program if available. If a program is not accessible, the product may be mixed with an undesirable substance (such as dirt or coffee grounds) and sealed in a container before being placed in the household trash. The tablets must not be flushed down the toilet or disposed of in wastewater, as mandated by regulatory documents.

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

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