International reference: 6 US FDA recalls for this ingredient

Superpotent Drug: Confirmed customer complaint of a single unit dose blister cavity containing 2 OXYCODONE HCl 5 mg tablets. (oxycodone)

Subpotent drug: Two lots of Oxycodone and Acetaminophen Capsules, USP 5/500 mg are being recalled due to low out of specification (OOS) assay result obtained at expiry (24 months) for the oxycodone portion of the product. (oxycodone)

Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities. (oxycodone)

Labeling: Missing Label (oxycodone)

Labeling: Incorrect or Missing Lot and/or Exp Date: Lot FG10517 is mislabeled on the primary container with Lot FG01517, shipper labels and invoices contain the correct lot number of FG10517. (oxycodone)

Adulterated Presence of Foreign Tablets: Customer complaint that some Endocet 10 mg/325 mg tablets were found mixed in a bottle with Endocet 10 mg/650 mg tablets. (oxycodone)

US-market enforcement records (OpenFDA), shown for reference - not specific to this product in Tanzania.

Registered Tanzania · TMDA

Adamycin 5%

Oxycodone Hydrochloride 50 mg

TAN 20 VM 0235 Solution for injection INN generic

What it does

Oxycodone is a strong painkiller used to relieve moderate to severe pain.

Commonly used for: pain relief (analgesia)

Read more in plain English ↓

Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

Ask about this medicine

Answers come only from this medicine's registration record, BNF monograph and interaction data - not medical advice.

Medicine sourcing is available in Kenya only. We don't sell or dispense medicines - licensed pharmacies do.

Sourcing - Kenya only

Registration & product details

Registration no.
TAN 20 VM 0235
Registration date
2025-07-06
Expiry date
2030-07-04
Status
Registered/Compliant
Active ingredient
Oxycodone Hydrochloride 50 mg
Strength
-
Pack size
-
Therapeutic class
-
Applicant / LTR
BIMEDA AMEA LTD
Country of origin
CHINA
Manufacturer location
China, Chong Qing Shi, Rong Chang Qu, 昌州大道CJ5G+837 邮政编码: 402493

Source: Tanzania Medicines and Medical Devices Authority · fetched 2026-06-19 02:01:20 · updated 2026-07-13 03:13:52

Drug Interactions

73
Check interactions

Pharmacodynamic Warnings

Oxycodone appears in TABLE 11: Drugs with CNS depressant effects

Severe (6)

Opioids - decreases concentration

Brigatinib potentially decreases the concentration of opioids (alfentanil, fentanyl). Avoid. Also see TABLE 6 p. 1518

Severe Theoretical

Opioids - increases exposure

Ceritinib is predicted to increase the exposure to opioids (alfentanil, fentanyl). Avoid. Theoretical → Also see TABLE 6 p. 1518

Severe Theoretical

Opioids - increases risk of cnstoxicity

Ritonavir increases the risk of CNS toxicity when given with opioids (pethidine). Avoid.

Severe Study

Opioids - decreases exposure

Lorlatinib is predicted to decrease the exposure to opioids (alfentanil, fentanyl). Avoid.

Severe Theoretical

Opioids - increases risk of adverse effects

Selegiline increases the risk of adverse effects when given with opioids (pethidine). Avoid. Also see TABLE 13 p. 1520

Severe Anecdotal

Opioids - increases exposure

Selpercatinib is predicted to increase the exposure to opioids (alfentanil, buprenorphine). Avoid.

Severe Study

Moderate (44)

Opioids - increases exposure

Dronedaroneispredictedtoincreasetheexposuretoopioids (alfentanil,buprenorphine,fentanyl,oxycodone).Monitorand adjustdose.oStudy →AlsoseeTABLE6p.1518

Moderate Study

Opioids - increases concentration

Amiodarone is predicted to increase the concentration of opioids (fentanyl). Monitor and adjust dose. Also see TABLE 6 p. 1518.

Moderate Theoretical

Opioids - decreases concentration

Carbamazepine decreases the concentration of opioids (tramadol). Adjust dose.

Moderate Study

Opioids - increases exposure

Miconazole is predicted to increase the exposure to opioids (alfentanil). Use with caution and adjust dose.

Moderate Theoretical

Opioids - increases exposure

Antifungals, azoles (fluconazole, isavuconazole, posaconazole) are predicted to increase the exposure to opioids (alfentanil, buprenorphine, fentanyl, oxycodone). Monitor and adjust dose.

Moderate Study

Unknown (23)

Drugs That Cause Serotonin Syndrome - increases risk of serotonin syndrome

Opioids (tapentadol) are predicted to increase the risk of serotonin syndrome when given with drugs that cause serotonin syndrome (see TABLE 13 p. 1520). Theoretical drugs that reduce serum potassium.

Unknown Theoretical

Opioids - additive effect

Clozapine can cause constipation, as can opioids; concurrent use might increase the risk of developing intestinal obstruction. Also see TABLE 11 p. 1519

Unknown Anecdotal

Opioids - increases exposure

Asciminibispredictedtoincreasetheexposuretoopioids (alfentanil).rTheoretical

Unknown Theoretical

Opioids - increases exposure

Bictegravirispredictedtoincreasetheexposuretoopioids (methadone).oTheoretical

Unknown Theoretical

Opioids - increases exposure

Bulevirtideispredictedtoincreasetheexposuretoopioids (alfentanil).oTheoretical

Unknown Theoretical

Data from BNF 85 (British National Formulary). This is not a substitute for professional medical advice. Matched via: class

Disclaimer: This information is sourced from Tanzania Medicines and Medical Devices Authority (Tanzania). Always consult a qualified healthcare professional before using any medication.

About this medicine

Oxycodone is a strong painkiller used to relieve moderate to severe pain.

What it treats

  • pain relief (analgesia)

How it works

Oxycodone works by affecting the brain and nervous system to reduce the feeling of pain.

Who it's for

This medication is for adults and sometimes children who need strong pain relief.

Drug class

Opioids

Cautions

  • • Be careful if you are taking other medications that can cause sleepiness or slow down your breathing.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: oxycodone

BNF-referenced

Oxycodone is a potent opioid analgesic belonging to the class of drugs known as opioids. It is primarily used for the management of moderate to severe pain, often in patients requiring continuous pain relief. Oxycodone is available in various formulations, including immediate-release and extended-release forms, and is known for its efficacy in managing pain associated with surgical procedures, cancer, and chronic pain conditions. Due to its potential for abuse and dependence, oxycodone is classified as a controlled substance in many jurisdictions.

Mechanism of action

Oxycodone acts as an agonist at the mu opioid receptors in the central nervous system and peripheral tissues. It selectively binds to these receptors, leading to the inhibition of pain transmission and the modulation of pain perception. The drug's mechanism involves the activation of G protein-coupled receptor signaling pathways, which results in the inhibition of N-type voltage-operated calcium channels, thereby reducing the release of neurotransmitters responsible for pain signaling. Oxycodone also binds to kappa and delta opioid receptors at higher doses, contributing to its overall analgesic effect.

Pharmacodynamics

Oxycodone has a range of pharmacodynamic effects beyond analgesia, affecting multiple systems in the body. It induces dose-dependent respiratory depression by acting on the respiratory center in the brainstem, which can lead to significant adverse reactions, particularly in overdose situations. Additionally, oxycodone suppresses the cough reflex, reduces gastrointestinal motility leading to constipation, and can cause miosis (constriction of pupils). It may also influence cardiovascular stability by releasing histamine, which can result in flushing, pruritus, and decreased blood pressure. Furthermore, oxycodone affects endocrine functions, potentially leading to hormonal imbalances such as increased prolactin levels and decreased cortisol and testosterone levels.

Pharmacokinetics

Oxycodone is well absorbed from the gastrointestinal tract, with a bioavailability of approximately 60-87% for oral formulations. It undergoes extensive hepatic metabolism, primarily via CYP3A4 and CYP2D6 enzymes, leading to the formation of active metabolites such as noroxycodone and oxymorphone. The drug has a volume of distribution of about 3-5 L/kg and is approximately 45% protein-bound in plasma. The elimination half-life of oxycodone ranges from 3 to 5 hours, but this can be extended in cases

Adverse effects

  • Respiratory depression
  • CNS depression
  • Constipation
  • Nausea
  • Vomiting
  • Dizziness
  • Pruritis
  • Flushing
  • Sweating
  • Decreased blood pressure

Interactions

  • Dronedarone
  • Antifungals (azoles)
  • Cobicistat
  • Crizotinib
  • Idelalisib
  • Imatinib
  • Letermovir
  • Clarithromycin
  • Erythromycin
  • Mitotane

Precautions

  • Use with caution in patients with respiratory disorders
  • Monitor patients for signs of opioid dependence or misuse
  • Consider potential for drug interactions
  • Titrate dosage carefully to avoid respiratory depression

Pregnancy

Oxycodone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It may cause neonatal withdrawal syndrome if used in the third trimester.

Breast-feeding

Oxycodone is excreted in breast milk. Caution is advised when administering to nursing mothers due to the risk of sedation and respiratory depression in the infant.

Storage

Store in a cool, dry place, away from light. Keep out of reach of children.

Formulations

  • Oral tablets
  • Oral solution
  • Extended-release formulations

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: Oxycodonehydrochloride

BNF-referenced

Oxycodone hydrochloride is an opioid analgesic used to manage moderate to severe pain. It is particularly employed in palliative care settings, where pain control is essential for maintaining quality of life. Oxycodone acts on the central nervous system to alleviate pain and is often utilized as an alternative to morphine or in combination with other analgesics.

Indications

  • Moderate to severe pain
  • Palliative care
  • Postoperative pain

Dosage

Children: Refer to BNF for Children for appropriate dosing information based on age and weight.

Adults: Initially, 10 mg every 12 hours, to be increased if necessary according to severity of pain.

Mechanism of action

Oxycodone exerts its analgesic effects primarily by binding to mu-opioid receptors in the brain and spinal cord. This binding inhibits the release of neurotransmitters involved in pain signaling and alters the perception of pain. Oxycodone also has an affinity for kappa and delta opioid receptors, contributing to its overall analgesic profile. The interaction with these receptors activates intracellular signaling pathways that lead to decreased neuronal excitability and pain transmission.

Pharmacodynamics

As a potent opioid, oxycodone provides effective pain relief through its action on opioid receptors. It has a relatively rapid onset of action, making it suitable for acute pain management. The drug's effectiveness can be influenced by individual patient factors, including previous opioid exposure, pain severity, and specific pain conditions.

Pharmacokinetics

Oxycodone is well-absorbed following oral administration, with a bioavailability of approximately 60-87%. Peak plasma concentrations are typically reached within 1-2 hours. It is metabolized primarily in the liver via CYP3A4 and CYP2D6 enzymes, producing both active and inactive metabolites. Oxycodone has a half-life of about 3-4 hours, and its elimination is predominantly renal, necessitating dose adjustments in patients with renal impairment.

Contra-indications

  • Acute abdomen
  • Chronic constipation
  • Cor pulmonale
  • Delayed gastric emptying
  • Pancreatitis
  • Toxic psychosis

Adverse effects

  • Anxiety
  • Bronchospasm
  • Drowsiness
  • Nausea
  • Vomiting
  • Constipation
  • Respiratory depression

Interactions

  • CNS depressants may enhance the sedative effects of oxycodone
  • MAO inhibitors may increase the risk of serotonin syndrome
  • Alcohol may increase the risk of respiratory depression

Precautions

  • Use with caution in patients with respiratory impairment
  • Monitor for signs of abuse and dependence
  • Adjust dose in patients with renal or hepatic impairment

Pregnancy

Oxycodone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It may cause respiratory depression in newborns.

Breast-feeding

Oxycodone is excreted in breast milk. Caution should be exercised when administered to nursing mothers, as it may cause sedation or respiratory depression in the infant.

Storage

Store in a cool, dry place. Keep out of reach of children. Protect from light.

Formulations

  • Oxycodone hydrochloride 5 mg tablets
  • Oxycodone hydrochloride 10 mg tablets
  • Oxycodone hydrochloride 20 mg tablets
  • Oxycodone hydrochloride oral solution
BNF 85 (British National Formulary) p.523 BNF for Children 2019-2020 p.314 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: oxycodone

PubChem CID 5284603

Molecular formula: C18H21NO4

Mechanism of action

The full mechanism of oxycodone is not known. Under conditions of inflammation or hyperalgesia, opioid receptors in the heart, lungs, liver, gastrointestinal tract, and reproductive system are upregulated and transported to nerve terminals. Oxycodone and its active metabolites, noroxycodone, oxymorphone, and noroxymorphone are opioid agonists. These compounds passively diffuse across the blood brain barrier or may be actively transported across by an unknown mechanism. Oxycodone and its active metabolites can selectively bind to the mu opioid receptor, but also the kappa and delta opioid receptors in the central nervous system and periphery, and induce a G protein coupled receptor signalling pathway. Activation of mu opioid receptors inhibits N-type voltage operated calcium channels, inhibiting responses to pain. Oxycodone is a full opioid agonist and is relatively selective for the mu-opioid receptor, although it can bind to other opioid receptors at higher doses. The principal therapeutic action of oxycodone is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with oxycodone. Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression. The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug. ... Oxycodone has the same mechanism of action as other opioids: binding to a receptor, inhibition of adenylyl-cyclase and hyperpolarization of neurons, and decreased excitability. These mechanisms also play a part in the onset of dependence and tolerance. ...

Pharmacodynamics

Oxycodone acts directly on a number of tissues not related to its analgesic effect. These tissues include the respiratory centre in the brain stem, the cough centre in the medulla, muscles of the pupils, gastrointestinal tract, cardiovascular system, endocrine system, and immune system. Oxycodone's effect on the respiratory centre is dose dependant respiratory depression. The action on the cough centre is suppression of the cough reflex. Pupils become miopic or decrease in size, peristalsis of the gastrointestinal tract slows, and muscle tone in the colon may increase causing constipation. In the cardiovascular system histamine may be released leading to pruritis, red eyes, flushing, sweating, and decreased blood pressure. Endocrine effects may include increased prolactin, decreased cortisol, and decreased testosterone. It is not yet known if the effects of opioids on the immune system are clinically significant.

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.