Hydroxycarbamid 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.

Overview of Hydroxycarbamid Teva

Quick Facts Overview

Property Description
Active Ingredient Hydroxycarbamide (Hydroxyurea)
Form Solid oral dosage (Tablets or Capsules)
Pharmacological Class Antimetabolite, Cytotoxic agent
Common Use Management of myeloproliferative and hemoglobin disorders
Origin Synthetic chemical compound

What Type of Medicine is Hydroxycarbamid Teva?

Hydroxycarbamid Teva is a synthetic, prescription-only medication that contains Hydroxycarbamide as its sole active ingredient. This chemical substance is classified as an Antimetabolite and a Cytotoxic agent. The medicine is a single active substance product prepared for systemic administration. The brand, manufactured by Teva, offers a oral generic alternative containing the active ingredient, Hydroxycarbamide.

Its classification as an Antimetabolite is clinically recognized for its interference with the metabolic pathways required for cell replication, which is the foundational mechanism that allows the compound to slow rapid cell growth. This class of drugs functions by blocking the production of genetic material.

Hydroxycarbamide: Composition and Oral Dosage Form

The medicine is formulated for systemic administration and is supplied as a solid oral dosage form, typically either tablets or capsules, for convenient ingestion by adult patient groups. The composition includes the therapeutic agent, Hydroxycarbamide, alongside essential pharmaceutical excipients like fillers and binders, necessary to produce a stable and absorbable oral preparation.

General Therapeutic Purpose of Hydroxycarbamid Teva

The general therapeutic purpose of this medication is to modulate cell proliferation in chronic conditions characterized by excessive cellular activity. Hydroxycarbamide products are used orally to treat various chronic hematological conditions. The mechanism involves DNA synthesis inhibition, achieved through its action as a Ribonucleotide reductase inhibitor. This key action allows the drug to regulate the overproduction of specific blood cells seen in myeloproliferative disorders and also offers a distinct benefit by improving red blood cell function in inherited conditions such as sickle cell disease.

Regulatory References

  1. Hydroxyurea: MedlinePlus Drug Information
  2. MedlinePlus Drug Information

What side effects are possible with Hydroxycarbamid Teva?

Hydroxycarbamid Teva: Possible side effects and safety information

The safety profile of Hydroxycarbamid Teva is primarily characterized by its potential for myelosuppression, a critical and dose-limiting effect on the bone marrow that reduces the production of blood cells. The complete status of the blood, including hemoglobin, white blood cell count, and platelet count, must be determined at baseline and monitored regularly throughout treatment, typically at least weekly.

Treatment is contraindicated in patients with marked bone marrow depression (e.g., leukopenia <2.5 imes 10^9/ L or thrombocytopenia <100 imes 10^9/ L) or severe anemia. Therapy must be interrupted if blood counts fall below specified thresholds and only resumed when counts recover. Bone marrow depression is more likely in patients previously treated with radiotherapy or cytotoxic chemotherapy.

Hydroxycarbamide is classified as a human carcinogen, with a documented risk of developing secondary malignancies, including skin cancer and secondary leukemia, particularly with long-term use. Patients are advised to use sun protection and be monitored for the development of new malignancies.

Other clinically significant adverse reactions include Embryo-Fetal Toxicity. The drug can cause fetal harm, and it is strictly contraindicated during pregnancy and breastfeeding. Effective contraception is required for women of childbearing potential during therapy and for a period afterward, as well as for male patients with female partners of reproductive potential.

Serious Adverse Reactions and Contraindications:

Classification Key Risks/Limitations
Most Common Serious Risk Severe Myelosuppression (Leukopenia, Thrombocytopenia, Anemia)
Long-Term Safety Risk Secondary Malignancies (Skin Cancer, Leukemia)
Population Restriction Contraindicated in Pregnancy/Breastfeeding; Avoided with Live Vaccines
Other Significant Risk Cutaneous Vasculitic Toxicities (Ulcerations, Gangrene)

Other reported adverse events involve the gastrointestinal system (stomatitis, nausea, vomiting), skin (maculopapular rash, hyperpigmentation, alopecia), and nervous system (headache, dizziness, confusion). In HIV-infected patients receiving certain antiretroviral agents (particularly didanosine with or without stavudine), fatal cases of pancreatitis, hepatotoxicity/hepatic failure, and severe peripheral neuropathy have been reported, making this combination inadvisable.

Overdose and Emergency Response

Overdose and when to Seek Help

Overdose with Hydroxycarbamide is defined by severe, acute toxicity affecting rapidly dividing cells. Documented clinical manifestations of overexposure include pronounced sores in the mouth and throat (mucous membrane toxicity) and severe pain, redness, swelling, and scaling on the hands and feet (cutaneous manifestations). A further documented presentation is the darkening of the skin (hyperpigmentation).

The most severe outcome from overdose is life-threatening myelosuppression, resulting in critical reductions in white blood cells and platelets. Acute overdose may also lead to serious central nervous system and systemic effects.

Regulatory guidance mandates that immediate medical attention must be sought for any suspected overdose. Emergency services (e.g., 911) must be called if the individual experiences severe symptoms such as collapse, a seizure, trouble breathing, or cannot be awakened.

Treatment is defined as symptomatic and supportive, as official regulatory sources confirm that no specific antidote is known for Hydroxycarbamide overexposure. Management procedures include careful laboratory monitoring of Complete Blood Count (CBC) and platelet counts, and may involve supportive interventions such as transfusions or activated charcoal administration.

Therapeutic Uses of Hydroxycarbamid Teva

What Hydroxycarbamid Teva Treats: Main Uses and Benefits

Hydroxycarbamide is commonly used across conditions presenting with acute episodes in multiple therapeutic domains, primarily involving the treatment of specific cancers and the management of a severe blood disorder.

The medicine is applied in addressing conditions involving episodic or fluctuating manifestations, such as sickle cell disease (SCD), where it assists with managing symptoms that become more disruptive during flare-ups. It is also relevant in contexts marked by increased discomfort or tension across myeloproliferative disorders (MPNs) like chronic myelocytic leukemia (CML), polycythemia vera (PV), and essential thrombocythaemia (ET), and certain solid tumors, including head and neck cancers and melanoma.

The use of hydroxycarbamide contributes to improved comfort during periods of heightened symptoms and provides supportive relief when symptoms interfere with routine activities, and may help patients cope more steadily with symptom fluctuations. The treatment is considered relevant often used during phases when symptoms become more noticeable, particularly when supportive symptom management is appropriate.

“May help maintain a sense of stability when symptoms are more noticeable.”

Quick Fact: Applicable within clinical settings that involve Acute or Disruptive Symptom Patterns

Eligibility and Restrictions for Use

The official regulatory profile for Hydroxycarbamid Teva (Hydroxyurea) defines strict population-based eligibility rules, primarily centered on hematological status, organ function, and reproductive potential.


Eligibility Scope

Category Official Regulatory Statement
Populations for whom use is allowed Adults, adolescents, and children (from 9 months or 2 years, depending on product/indication) for approved uses, such as Sickle Cell Disease and certain myeloproliferative disorders.
Populations for whom use is contraindicated Patients with marked bone marrow depression, severe anemia, severe renal impairment ( CrCl < 30 mL/min), severe hepatic impairment, or a known hypersensitivity to hydroxyurea.
Age-related eligibility rules Pediatric patients: Safety and efficacy are not established in infants under 9 months to 2 years, depending on the approved product. Geriatric patients: May be more sensitive to effects due to the higher likelihood of impaired renal function.
Pregnancy and lactation eligibility status Pregnancy: Use is not recommended or contraindicated due to the risk of fetal harm. Lactation: Breastfeeding must be stopped as the drug is excreted into human milk.
Eligibility-related restrictions Use is restricted with caution in mild-to-moderate renal or hepatic impairment and in patients with a history of radiation or cytotoxic therapy. The combination with didanosine and/or stavudine is avoided.

Resulting Eligibility Structure

Official eligibility statements:

  • The medicine is contraindicated in patients with marked bone marrow depression, severe organ impairment, or a known hypersensitivity to the drug.
  • Use is not recommended during pregnancy or breastfeeding, and strict contraception is required for both male and female patients of reproductive potential.
  • Caution is required when using the medicine in patients with mild-to-moderate organ impairment, in older adults, and in those who have received prior radiotherapy.

What should I know about interactions with other medicines?

Hydroxycarbamid Teva Interactions with other medicines and products

Official regulatory information describes specific combination restrictions for Hydroxycarbamide, which are primarily based on additive toxicity and immunosuppressive effects. The profile also includes constraints related to laboratory test interference.

Classification Interacting Agents / Classes Restriction Summary (Official Labeling)
Avoid Combination Live Virus Vaccines Concomitant use should be avoided due to the immunosuppressive effect, which may potentiate viral replication and increase the risk of severe infection.
Avoid Combination Didanosine and Stavudine The triple combination with Hydroxycarbamide has been associated with reports of fatal hepatic events and severe peripheral neuropathy and should be avoided.
Increased Toxicity Risk Other Cytotoxic Agents / Radiotherapy The risk of myelosuppression (bone marrow depression) is documented as being potentiated by previous or concurrent use of other cytotoxic therapies or radiation.
Increased Toxicity Risk Interferon Therapy A history of, or current use of, interferon therapy is associated with an increased risk of cutaneous vasculitic toxicities, such as ulcerations.

Procedural and Analytical Constraints

Hydroxycarbamide is officially documented to cause analytical interference with certain laboratory assays. It may render falsely elevated results in tests for urea, uric acid, and lactic acid. Furthermore, the medicine may falsely elevate sensor glucose results in certain Continuous Glucose Monitoring (CGM) systems.

Mechanism of Action

️ Targeting DNA Synthesis via Enzyme Inhibition

This mechanistic domain centers on the enzyme Ribonucleotide reductase (RR), which is immediately and reversibly inhibited by the drug. By chemically quenching a free radical at the enzyme's active site, the drug blocks the synthesis of deoxyribonucleotides (dNTPs), the building blocks for DNA. This S-phase-specific action starves rapidly dividing cells, resulting in a G1-S phase arrest, and causing hematopoietic suppression (the reduction in the rate of proliferation of specific blood cell lines). This process specifically reduces the production of rapidly proliferating cell lines, such as granulocytes and platelets, within the bone marrow.


Genetic Reprogramming and Fetal Hemoglobin Induction

A separate, critical mechanistic domain involves the drug's ability to activate the gamma globin gene. This process is driven by stress erythropoiesis and potentially the activation of the Nitric Oxide (NO) signaling pathway, which subsequently raises intracellular cGMP levels. The resulting synthesis of Fetal Hemoglobin (HbF) structurally interferes with the molecular aggregation of sickle hemoglobin. This cellular alteration increases the hydration and deformability of red blood cells, which affects the physical flow properties of these cells.

Dosage and Administration Information

Instruction Map: How to use Hydroxycarbamid Teva — Administration Guidelines

Hydroxycarbamid Teva is administered through the oral route via capsules, tablets, or oral solution. Its use is based on continuous, standardized regimens, with a focus on initial calculation and subsequent titration.

The starting dose for all approved uses is determined by the patient's actual or ideal body weight, whichever is less. This initial amount is taken once daily and must be maintained for a long period—typically 8 to 12 weeks—before any adjustment is made. Dose changes are implemented in small increments of 5 mg/kg/day under clinical supervision.


Administration Protocol and Adjustments

Instruction Detail
Dose Calculation Basis Actual or ideal body weight (lesser value used).
Frequency Pattern Once daily for continuous therapy; may be intermittent for certain cancer regimens.
Renal Impairment Rule A 50% reduction in the starting dose is required for patients with moderate to severe kidney impairment (Creatinine Clearance <60 mL/min).
Preparation Specifics Capsules must be swallowed whole. Tablets can be dispersed in a small quantity of water for immediate consumption if necessary.
Handling Precaution Due to its cytotoxic nature, special precautions like hand washing are required after contact with the medication.
Missed Dose Rule If a scheduled dose is missed, do not take a double dose to compensate.

Connection to the overall use protocol: The protocol establishes Hydroxycarbamide as a continuously used oral medication with dosing tightly structured by specific body metrics and mandated renal adjustments. This regimen relies on infrequent, incremental titration over a long course to standardize the administration pattern as established for this medication.

Recent Clinical Evidence

Research Evidence / Overview of Studies


Research on Treatment Outcomes

Research has explored whether this approach may affect clinical outcomes in adults with severe sickle cell anemia (SCA). Studies analyzed results from clinical trials that reported a reduction in the annual rate of painful vaso-occlusive crises (VOCs). For example, one large adult trial reported a median annual crisis rate that was 44% lower among patients receiving the medication compared to placebo.

One study also examined whether the combination treatment was associated with a reduction in emergency department visits and hospitalizations. The study reported that participants receiving the treatment showed lower rates of acute chest syndrome and required fewer blood transfusions over the study period.


Research into Biological Processes

Research examined the underlying biological processes, including the role of fetal hemoglobin (HbF) induction. Hydroxycarbamid Teva is thought to work by increasing the production of HbF, a type of hemoglobin that interferes with the sickling of red blood cells. Studies have investigated this hypothesized process using laboratory biomarkers.


Evidence on Healthcare Utilization and Long-term Use

Studies evaluated whether this approach could be associated with a reduction in hospital days per year. Clinical trials reported reductions in the overall utilization of acute care services among participants. This finding remained consistent in large, real-world studies assessing the use of the drug in children and adults with SCA over periods of several years.

Comparative studies also examined the drug's use in children with elevated stroke risk, reporting that it offered a similar benefit to the standard therapy (chronic blood transfusions) for lowering stroke-related risk indicators.

Frequently Asked Questions (FAQ)

Common questions about Hydroxycarbamid Teva (FAQ)

Q: Is Hydroxycarbamid Teva the same as hydroxyurea?

A: Hydroxycarbamid Teva is the brand name for a product that contains Hydroxycarbamide as its sole active ingredient. Hydroxycarbamide is the official non-proprietary name for the compound also known as hydroxyurea. Therefore, the active substance is the same.

Q: Can Hydroxycarbamid Teva be taken with food, or does it matter?

A: Official drug information states that this medication can be taken with or without food. There are no specific restrictions on timing your dose relative to meals for the purpose of absorption.

Q: Does Hydroxycarbamid Teva need to be taken at the exact same time every day?

A: Yes, regulatory information recommends taking the medication at the same time each day. This approach supports maintaining consistent levels of the active substance in the body, which is consistent with the once-daily regimen.

Q: Do people generally take Hydroxycarbamid Teva for a short time or long term?

A: Hydroxyurea is typically used for long-term treatment in its approved uses, such as chronic blood disorders. The exact duration of therapy is dependent on the specific medical condition being treated and how the patient responds over time.

Q: Are there any serious side effects associated with long-term use of Hydroxycarbamid Teva?

A: Official labeling states that long-term use is associated with a documented risk of developing secondary malignancies, which are new cancers that occur later in life. These include skin cancer and secondary leukemia. Regulatory information indicates that monitoring of the skin is required due to this risk.

Q: Can Hydroxycarbamid Teva cause hair loss?

A: The official product information reports that this medication can cause alopecia, which is the medical term for hair loss. This side effect is generally described as temporary, and normal hair growth has been reported to return after treatment is stopped.

Q: Can Hydroxycarbamid Teva be crushed or opened?

A: The capsules must be swallowed whole due to the drug’s cytotoxic (cell-harming) nature. However, if the medicine is supplied as a tablet form, regulatory documents permit it to be dispersed in a small amount of water for immediate consumption. Regulatory handling precautions, such as hand washing, are necessary when handling the drug or preparing the dispersed tablets.

Q: What is the difference between Hydroxycarbamid Teva and generic hydroxyurea?

A: Hydroxycarbamid Teva is a specific brand of the generic drug, Hydroxycarbamide. According to official documentation, the active ingredient and core regulatory profile are the same. Different brands may be approved for slightly different uses, but they contain the same active therapeutic substance.

Q: Does Hydroxycarbamid Teva affect the immune system?

A: Hydroxyurea is known to cause bone marrow suppression—a condition where the body reduces the production of blood cells. Regulatory warnings indicate that this effect can potentially decrease the body's ability to fight off infections, which is why close monitoring is an essential part of the treatment protocol.

Q: Are there any specific vaccines that should be avoided while using Hydroxycarbamid Teva?

A: Official documents state that live, attenuated viral or bacterial vaccines should generally be avoided while on this treatment. This restriction is in place because the medicine can weaken the immune system, potentially leading to a severe infection if a live vaccine is administered. Consultation with the healthcare provider about any necessary vaccinations is an important part of treatment planning.

Q: Is it safe to take over-the-counter pain relievers while using this medicine?

A: Official patient information indicates that discussion with a healthcare provider is appropriate before starting pain relievers like Ibuprofen, Naproxen, or Aspirin. This is because non-steroidal anti-inflammatory drugs (NSAIDs) may increase the risk of bleeding or interact with the treatment regimen.

Q: Does Hydroxycarbamid Teva interact with herbal supplements?

A: Official documentation instructs patients to inform their healthcare providers of all medications, including over-the-counter medicines, vitamins, and herbal products. This is necessary to review the potential for interactions that may occur and affect the treatment.

Q: Can alcohol be consumed while taking Hydroxycarbamid Teva?

A: Patient education materials indicate that smoking or drinking alcohol should be discussed with the healthcare provider first. This is because alcohol consumption may potentially worsen some of the medicine's side effects and affect the overall effectiveness of the treatment.

Q: How long does it usually take to see the effects of Hydroxycarbamid Teva?

A: For effectiveness in certain conditions, an adequate trial period of therapy is generally considered six weeks according to clinical trial information. Separately, dosing adjustments are not typically considered until the treatment has been maintained for at least 8 to 12 weeks.

Q: Do the side effects of Hydroxycarbamid Teva eventually go away?

A: Some side effects, such as hair loss, are generally described in official patient resources as being temporary, with normal condition often resuming after treatment is complete. However, the patient's reaction to the drug is individual, and other serious effects may require stopping the medication.

Q: What does official documentation say about driving while taking Hydroxycarbamid Teva?

A: Official information indicates that this drug can cause dizziness and drowsiness, particularly when treatment begins or when the dose is changed. Regulatory information indicates that activities like driving, operating heavy machinery, or performing tasks requiring alertness should be avoided if a patient experiences drowsiness or dizziness.

Q: Is Hydroxycarbamid Teva ever stopped suddenly, or is a doctor-supervised weaning needed?

A: Regulatory documents warn against suddenly stopping this medication on one's own. Sudden discontinuation can potentially cause adverse health events. Consultation with the healthcare provider is necessary when considering stopping or interrupting treatment.

Q: How should unused Hydroxycarbamid Teva be stored?

A: The medication should be stored at room temperature, away from excessive heat and moisture, and kept out of the reach of children. Consultation with a healthcare professional or pharmacist is the appropriate method for determining the proper disposal of any outdated or unused medication.

Q: How often do people need to visit their doctor when starting Hydroxycarbamid Teva?

A: While the frequency of direct doctor visits is determined by the healthcare provider, blood monitoring is officially mandated at least once a week when therapy is initiated or when a dose adjustment is made. This is to closely monitor for blood-related side effects.

Q: What are the major reasons someone might need to stop taking Hydroxycarbamid Teva?

A: Treatment must be interrupted or stopped if blood counts fall below specific levels, such as when the white blood cell count is too low or the platelet count is too low. Therapy is only resumed when these counts return to acceptable levels.

Q: Does Hydroxycarbamid Teva affect kidney function?

A: Official information indicates that hydroxyurea is mainly eliminated by the kidneys, meaning patients with impaired kidney function will have higher drug exposure. Regulatory guidelines require a starting dose reduction for patients with moderate to severe kidney impairment. Research has also explored the drug's potential effects on kidney health over time.

Q: Does Hydroxycarbamid Teva affect liver function?

A: Official labeling does not provide specific guidance for dose adjustment in general liver impairment. However, fatal liver-related events were reported in HIV-infected patients treated with a combination including hydroxyurea and certain antiretroviral agents.

Q: Is it common to feel tired or fatigued when taking Hydroxycarbamid Teva?

A: Yes, official documentation reports that some people experience excessive tiredness or weakness as a side effect. This is a symptom that patients are generally encouraged to discuss with their healthcare provider.

Q: Can Hydroxycarbamid Teva be used by people with a history of gout?

A: Hydroxyurea can raise serum uric acid levels, which is a substance that may trigger or worsen gout. Monitoring of uric acid levels is advised, and adjustment of existing gout medication may be considered by a healthcare professional.

Q: Are there any foods or drinks that must be avoided?

A: There are no specific foods or drinks that are known to interfere with the absorption of the medicine. However, official sources indicate that avoiding alcohol is generally discussed with the healthcare team, and some patients find that avoiding spicy, salty, or greasy foods can help manage common digestive side effects like nausea or mouth sores.

Q: What should a person do if they suspect an interaction with another drug?

A: If a potential interaction is suspected, patients are directed to contact their healthcare team promptly. It is necessary to disclose all prescription medications, over-the-counter drugs, vitamins, and herbal products to prevent potential interactions before they occur.

Q: Are there any known issues with Hydroxycarbamid Teva and dental procedures?

A: Official patient education indicates that consultation with the healthcare team is necessary before undergoing any dental work or medical procedures. This caution is related to the drug's effect on blood counts and potential risks associated with procedures when bone marrow suppression is present.

Q: Can Hydroxycarbamid Teva cause digestive issues like nausea or stomach upset?

A: Yes, regulatory documents list gastrointestinal issues as reported side effects. These can include common issues like nausea, vomiting, and diarrhea, as well as mouth inflammation (stomatitis).

Q: Are there specific patient groups where Hydroxycarbamid Teva is generally not recommended?

A: The medicine is generally not recommended or is strictly avoided in groups such as those with marked bone marrow depression, patients with a known severe hypersensitivity to the drug, and women who are pregnant or breastfeeding. Its use is also avoided in combination with certain HIV antiretroviral agents.

How should Hydroxycarbamid Teva be stored and disposed of?

Official Storage and Disposal Profile

Regulatory authorities classify this medication as a Cytotoxic Agent, necessitating strict protocols for handling and disposal to prevent accidental exposure.

Storage and Handling Requirements Official Regulatory Statements
Child Safety Keep the medication away from children and pets.
Handling Wash hands with soap and water before and after handling the bottle or capsules. Do not open the capsules and avoid exposure to crushed powder.
Exposure Management If skin contact occurs, wash the affected area immediately and thoroughly with soap and water. If eye contact occurs, flush thoroughly with water or an isotonic eyewash for at least 15 minutes.
Spill Protocol Immediately wipe up any spilled powder with a damp disposable towel, discard it in a closed container, and clean the area three times with detergent and water.
Disposal Contact a healthcare professional or pharmacist for instructions on how to properly dispose of outdated or unused capsules. Empty capsules and cleanup materials must be placed in a closed container.

This structure ensures adherence to mandated safety procedures defined in official government labeling.

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

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