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Codeine Sulfate

FDA-approved product (tablet, oral), marketed as Codeine Sulfate.

Registered studies
23
Lab records
0
Pathogens at ≥40%
3 of 4

Chemical structure

Chemical structure of Codeine Sulfate
A drawing shows what the molecule is, not what it does.

Existing / approved use

Documented · FDA, WHO, ChEMBL

Approved for

  • Cough
  • Drug dependence
  • Migraine disorder
  • Muscle spasm
  • Pain

Indications ChEMBL records as approved, from FDA and DailyMed labels. Label ↗

WHO therapeutic group
Natural opium alkaloids; Opium alkaloids and derivatives
Anti-infective classification
Not classified as an anti-infective.

Repurposing investigation

This medicine is being investigated here for AI-predicted antimicrobial activity against M. tuberculosis, MRSA and K. pneumoniae. It was surfaced computationally for further investigation; it is not an established treatment for these infections.

AI-predicted activity

AI prediction · nothing measured
  • MRSA40.6% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • E. coli37.8% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • K. pneumoniae48.8% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • M. tuberculosis43.3% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.

A model’s estimate of laboratory activity against each pathogen species. It is not clinical effectiveness.

Evidence

Clinical and experimental

Documented evidence

Clinical

23registered studies name this medicine, for any condition. See them below.

Experimental

No evidence found

No laboratory measurement against the four pathogens in the ChEMBL records loaded here.

Docking

Computational · nothing measured

Dihydrofolate reductase ↗ (E. coli)

-6.5 kcal/mol

0better fit →-12

KPC-2 carbapenemase ↗ (K. pneumoniae)

-7.4 kcal/mol

0better fit →-12

Enoyl-ACP reductase (InhA) ↗ (M. tuberculosis)

-7.0 kcal/mol

0better fit →-12

Dihydrofolate reductase ↗ (MRSA)

-7.2 kcal/mol

0better fit →-12

AutoDock Vina, one experimentally solved protein per pathogen. This project’s screening target is -7.0 kcal/mol, its own mark rather than a universal cutoff. A docking score is a structural hypothesis, not proof of binding, and requires experimental validation.

Other medicines to investigate

AI prediction · nothing measured

Other repurposing candidates: approved medicines besides Codeine Sulfate with AI-predicted activity ≥40% against the chosen pathogen, leaving out existing antimicrobials. They are computational candidates for further investigation, not alternatives and not recommendations.

Sorted by AI-predicted activity, high to low. The order is not a ranking of which medicine is better.

Registered studies

A registration describes a study; it does not establish a positive result.

  • Cutoff Assessment for Codeine in Fingerprint Sweat Relative to Oral Fluid, Following Controlled, Oral Administration of Codeine Phosphate Tablets to 40 Healthy Adults

    NCT07755267 · start 2026-01-28

    Registered record
    Registry ID
    NCT07755267
    Conditions
    Healthy Adult
    Interventions
    Determination of codeine phosphate
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Completed
    Start
    2026-01-28
    Completion
    2026-02-06
    Enrolment
    43

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHealthy Adult
    InterventionDetermination of codeine phosphate
    PhaseNot recorded
    Registry statusCompleted
  • PK of Codeine and Metabolites in Human Fingerprint Sweat, Oral Fluid, Blood and Urine

    NCT06519045 · start 2024-06-11

    Registered record
    Registry ID
    NCT06519045
    Conditions
    Pharmacokinetics
    Interventions
    Intelligent Fingerprinting Drug Screening System
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Unknown
    Start
    2024-06-11
    Completion
    2024-09-30
    Enrolment
    40

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionPharmacokinetics
    InterventionIntelligent Fingerprinting Drug Screening System
    PhaseNot recorded
    Registry statusUnknown
  • An Randomized Control Trial Comparing Two Drug Combinations for Pain Management After Third Molars Surgery

    NCT04874675 · start 2023-03

    Registered record
    Registry ID
    NCT04874675
    Conditions
    Impacted Third Molar Tooth; PAIN
    Interventions
    diclofenac / acetaminophen /codeine; ibuprofen/acetaminophen/codeine
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Suspended
    Start
    2023-03
    Completion
    2024-04
    Enrolment
    78

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionImpacted Third Molar Tooth; PAIN
    Interventiondiclofenac / acetaminophen /codeine; ibuprofen/acetaminophen/codeine
    PhaseNot applicable
    Registry statusSuspended
  • Evaluation of the Analgesic Efficacy of the Combination of Dexketoprofen + Paracetamol and the Combination of Naproxen Sodium + Codeine in Patients With Acute Dental Pain

    NCT06916234 · start 2023-01-10

    Registered record
    Registry ID
    NCT06916234
    Conditions
    Acute Dental Pain
    Interventions
    Dexketoprofen Trometamol + Paracetamol; Naproxen Sodium + Codeine Phosphate
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2023-01-10
    Completion
    2024-01-20
    Enrolment
    100

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionAcute Dental Pain
    InterventionDexketoprofen Trometamol + Paracetamol; Naproxen Sodium + Codeine Phosphate
    PhasePhase 4
    Registry statusCompleted
  • COMPARISON OF EFFICACY OF DIFFERENT DRUG COMBINATIONS IN ACUTE SCIATICA

    NCT05626140 · start 2021-09-28

    Registered record
    Registry ID
    NCT05626140
    Conditions
    Sciatica Acute; Sciatica
    Interventions
    Lacosamide 50 MG Oral Tablet [Vimpat]; Codeine Phosphate; Diclofenac Sodium
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2021-09-28
    Completion
    2022-07-31
    Enrolment
    120

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionSciatica Acute; Sciatica
    InterventionLacosamide 50 MG Oral Tablet [Vimpat]; Codeine Phosphate; Diclofenac Sodium
    PhasePhase 3
    Registry statusCompleted
  • Colonic Motor Patterns in Healthy Volunteers

    NCT05770960 · start 2018-06-27

    Registered record
    Registry ID
    NCT05770960
    Conditions
    Opioid-Induced Constipation
    Interventions
    Naloxegol; codeine phosphate; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2018-06-27
    Completion
    2019-05-09
    Enrolment
    15

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionOpioid-Induced Constipation
    InterventionNaloxegol; codeine phosphate; Placebo
    PhasePhase 4
    Registry statusCompleted
  • Efficacy of Naproxen-codeine, Naproxen+Dexamethasone, and Naproxen on Myofascial Pain

    NCT04066426 · start 2018-03-01

    Registered record
    Registry ID
    NCT04066426
    Conditions
    Temporomandibular Disorder
    Interventions
    naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2018-03-01
    Completion
    2019-07-15
    Enrolment
    200

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionTemporomandibular Disorder
    Interventionnaproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol
    PhasePhase 4
    Registry statusCompleted
  • Clinical Evaluation of the VIPUN Balloon Catheter 0.1

    NCT03239821 · start 2017-09-25

    Registered record
    Registry ID
    NCT03239821
    Conditions
    Healthy; Motility Disorder; Gastric Emptying
    Interventions
    VIPUN Balloon Catheter 0.1 deflated; Codeine Phosphate; Placebo; VIPUN Balloon Catheter 0.1 inflated
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Completed
    Start
    2017-09-25
    Completion
    2018-04-30
    Enrolment
    22

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHealthy; Motility Disorder; Gastric Emptying
    InterventionVIPUN Balloon Catheter 0.1 deflated; Codeine Phosphate; Placebo; VIPUN Balloon Catheter 0.1 inflated
    PhaseNot applicable
    Registry statusCompleted
  • Codeine on Pharyngeal and Esophageal Motility

    NCT03784105 · start 2017-09-07

    Registered record
    Registry ID
    NCT03784105
    Conditions
    Esophageal Motility Disorders
    Interventions
    Codeine Phosphate; Siripus simplex
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2017-09-07
    Completion
    2018-12-14
    Enrolment
    22

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionEsophageal Motility Disorders
    InterventionCodeine Phosphate; Siripus simplex
    PhasePhase 4
    Registry statusCompleted
  • E7 TCR T Cells for Human Papillomavirus-Associated Cancers

    NCT02858310 · start 2017-01-27

    Registered record
    Registry ID
    NCT02858310
    Conditions
    Papillomavirus Infections; Cervical Intraepithelial Neoplasia; Carcinoma In Situ; Vulvar Neoplasms; Vulvar Diseases
    Interventions
    E7 TCR cells; Aldesleukin; Fludarabine; Cyclophosphamide; EKG; Biopsy; Chest CT and MRI or PET; PFT; Granisetron; Ondansetron; Droperidol; Prochlorperazine; Diphenoxylate HCL; Atropine sulfate; Codeine sulfate; Loperamide; Indomethacin; Acetaminophen; Diphenhydramine HCL; Hydroxyzine HCL; Meperidine
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Completed
    Start
    2017-01-27
    Completion
    2025-07-02
    Enrolment
    224

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionPapillomavirus Infections; Cervical Intraepithelial Neoplasia; Carcinoma In Situ; Vulvar Neoplasms +1 more
    InterventionE7 TCR cells; Aldesleukin; Fludarabine; Cyclophosphamide +17 more
    PhasePhase 1 / Phase 2
    Registry statusCompleted
  • Bioequivalence Study of One Tablet of Paracetamol 1000 mg + Codeine 30 mg vs. Two Tablets of Paracetamol 500 mg + Codeine 30 mg

    NCT02902666 · start 2016-04

    Registered record
    Registry ID
    NCT02902666
    Conditions
    Healthy
    Interventions
    Paracetamol 1000 mg/codeine phosphate hemihydrate 30 mg tablet; Paracetamol 500 mg/codeine phosphate hemihydrate 30 mg tablet
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2016-04
    Completion
    2016-05
    Enrolment
    46

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHealthy
    InterventionParacetamol 1000 mg/codeine phosphate hemihydrate 30 mg tablet; Paracetamol 500 mg/codeine phosphate hemihydrate 30 mg tablet
    PhasePhase 1
    Registry statusCompleted
  • A Prospective Trial to Assess Cost and Clinical Outcomes of a Clinical Pharmacogenomic Program

    NCT02297126 · start 2015-03

    Registered record
    Registry ID
    NCT02297126
    Conditions
    Adverse Drug Reaction
    Interventions
    Pharmacogenetic Intervention Arm (pharmacogenetic testing)
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Completed
    Start
    2015-03
    Completion
    2019-05-03
    Enrolment
    4,465

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionAdverse Drug Reaction
    InterventionPharmacogenetic Intervention Arm (pharmacogenetic testing)
    PhaseNot applicable
    Registry statusCompleted
  • Codeine Phosphate/Guaifenesin ER Tablet 30 mg/600 mg Steady State Clinical Study

    NCT02572375 · start 2014-10

    Registered record
    Registry ID
    NCT02572375
    Conditions
    Cough
    Interventions
    Codeine Phosphate/Guaifenesin ER Tablet; Codeine Phosphate/Guaifenesin IR Tablet
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2014-10
    Completion
    2015-01
    Enrolment
    38

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionCough
    InterventionCodeine Phosphate/Guaifenesin ER Tablet; Codeine Phosphate/Guaifenesin IR Tablet
    PhasePhase 1
    Registry statusCompleted
  • Bioequivalence Study of Co-codamol 15mg/500mg Capsules vs Co-codamol 30mg/500mg Tablets in Healthy Subjects

    NCT03280095 · start 2014-09-23

    Registered record
    Registry ID
    NCT03280095
    Conditions
    Healthy
    Interventions
    co-codamol 15mg/500mg capsule; co-codamol 30mg/500mg tablet
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2014-09-23
    Completion
    2014-12-12
    Enrolment
    50

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHealthy
    Interventionco-codamol 15mg/500mg capsule; co-codamol 30mg/500mg tablet
    PhasePhase 1
    Registry statusCompleted
  • Single Dose Trial of Extended Release Combination Tablet Codeine and Guaifenesin

    NCT02157649 · start 2014-06

    Registered record
    Registry ID
    NCT02157649
    Conditions
    Cough
    Interventions
    IR Tablet under Fasted conditions; ER Tablet under Fed Conditions; ER Tablet under Fasted Conditions
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2014-06
    Completion
    2014-09
    Enrolment
    26

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionCough
    InterventionIR Tablet under Fasted conditions; ER Tablet under Fed Conditions; ER Tablet under Fasted Conditions
    PhasePhase 1
    Registry statusCompleted