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Palladone (Hydromorphone) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Palladone (Hydromorphone) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (12)
Death (3)

Reports by Reaction Type

Night Sweats (2)Weight Decreased (2)Alpha 2 Globulin Increased (2)Somnolence (2)Hepatotoxicity (2)Chest Pain (2)Depression (2)Hallucination (2)Vomiting (2)Dyspnoea (2)Nausea (2)Prostate Cancer (2)

Possible Palladone side effects in

Reported by a physician from Germany on 2012-08-17

Patient:

Reactions: Withdrawal Syndrome

Drug(s) suspected as cause:
Palexia Retard
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Palladone
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication



Possible Palladone side effects in 31 year old female

Reported by a pharmacist from Germany on 2012-08-02

Patient: 31 year old female

Reactions: Dyspnoea

Drug(s) suspected as cause:
Palladone



Possible Palladone side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-02

Patient: female, weighing 60.0 kg (132.0 pounds)

Reactions: Weight Decreased, Night Sweats, Alpha 2 Globulin Increased, Vomiting, Nausea, Drug Intolerance, Chest Pain, Depression, Hallucination

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Exalgo
    Dosage: 16 mg qd
    Administration route: Oral

Palladone
    Dosage: 8 mg, qd
    Administration route: Oral
    Start date: 2011-10-01

Exalgo
    Dosage: 16 mg, qd
    Administration route: Oral
    Indication: Back Pain
    Start date: 2011-01-01

Palladone
    Dosage: 12 mg, qd
    Administration route: Oral
    Indication: Back Pain
    Start date: 2010-09-01

Other drugs received by patient: Ramipril; Nebivolol HCL; Triamterene and Hydrochlorothiazide



Possible Palladone side effects in 79 year old female

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-06-27

Patient: 79 year old female, weighing 43.0 kg (94.6 pounds)

Reactions: Drug Interaction, Faecaloma

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Hydromorphone HCL
    Dosage: 8 mg, qd
    Administration route: Oral
    Indication: Pain
    Start date: 2009-05-01
    End date: 2009-08-24

Isoptin RR Plus
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2007-01-01

Palladone
    Dosage: 1.3 mg, qd
    Administration route: Oral
    Indication: Pain
    Start date: 2009-05-01
    End date: 2009-08-26

Losartan Potassium and Hydrochlorothiazide
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: Hypertension

Ibuprofen
    Dosage: 600 mg, qd
    Administration route: Oral
    Indication: Pain
    Start date: 2008-05-01

Other drugs received by patient: Pantoprazole; Domperidone; Falithrom; Celebrex; Pentaerythritol Tetranitrate



Possible Palladone side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-27

Patient: female, weighing 60.0 kg (132.0 pounds)

Reactions: Weight Decreased, Night Sweats, Alpha 2 Globulin Increased, Vomiting, Nausea, Chest Pain, Drug Intolerance, Depression, Hallucination

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Palladone
    Dosage: 12 mg, qd
    Administration route: Oral
    Indication: Back Pain
    Start date: 2010-09-01

Exalgo
    Dosage: 16 mg qd
    Administration route: Oral

Palladone
    Dosage: 8 mg, qd
    Administration route: Oral
    Start date: 2011-10-01

Exalgo
    Dosage: 16 mg, qd
    Administration route: Oral
    Indication: Back Pain
    Start date: 2011-01-01

Other drugs received by patient: Nebivolol HCL; Ramipril; Triamterene and Hydrochlorothiazide



Possible Palladone side effects in 31 year old female

Reported by a pharmacist from Germany on 2012-06-22

Patient: 31 year old female

Reactions: Dyspnoea

Drug(s) suspected as cause:
Palladone



Possible Palladone side effects in 81 year old male

Reported by a consumer/non-health professional from United States on 2012-02-24

Patient: 81 year old male, weighing 68.0 kg (149.6 pounds)

Reactions: Prostate Cancer, Hepatotoxicity, Dehydration, Toxicity To Various Agents

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Haldol
    Dosage: unk
    Administration route: Oral
    Indication: Nausea
    Start date: 2009-11-25
    End date: 2009-12-29

Palladone
    Dosage: 26 ug, qid
    Administration route: Oral
    Indication: Pain
    Start date: 2009-11-25
    End date: 2009-12-29

Exalgo
    Dosage: 32 mg, qd
    Administration route: Oral
    Indication: Pain
    Start date: 2009-12-13
    End date: 2009-12-29

Duragesic-100
    Dosage: unk
    Indication: Pain
    Start date: 2009-12-29

Other drugs received by patient: Furosemid / 00032601 /; Lyrica; Paroxetine; Kevatril; Zoladex; Metamizole; Omeprazole; Zometa; Lorazepam; Prednisone TAB; Movicol / 01625101 /; MCP / 00041901 /; Sunitinib Malate; Scopoderm / 00008701 /



Possible Palladone side effects in 81 year old male

Reported by a physician from Germany on 2012-02-21

Patient: 81 year old male, weighing 68.0 kg (149.6 pounds)

Reactions: Prostate Cancer, Hepatotoxicity, Dehydration, Toxicity To Various Agents

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Palladone
    Administration route: Oral
    Indication: Pain
    Start date: 2009-11-25
    End date: 2009-12-29

Haldol
    Administration route: Oral
    Indication: Nausea
    Start date: 2009-11-25
    End date: 2009-12-29

Hydromorphone HCL
    Administration route: Oral
    Indication: Pain
    Start date: 2009-12-13
    End date: 2009-12-29

Duragesic-100
    Indication: Pain
    Start date: 2009-12-29

Other drugs received by patient: Metamizole; Sunitinib Malate; Scopolamine; Moviprep; Omeprazole; Kevatril; Lyrica; Paroxetine; Metoclopramide; Zoladex; Furosemide; Lorazepam; Zometa; Prednisone



Possible Palladone side effects in male

Reported by a physician from Germany on 2012-01-11

Patient: male, weighing 90.0 kg (198.0 pounds)

Reactions: Hypotension, Somnolence, Accidental Exposure

Drug(s) suspected as cause:
Aspirin
    Dosage: one tablet
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-12-28

Torsemide
    Dosage: one tablet
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-12-28

Plavix
    Dosage: one tablet
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-12-28

Ramipril
    Dosage: one tablet
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-12-28

Clarithromycin
    Dosage: one tablet
    Indication: Pneumonia
    Start date: 2011-12-28

Albuterol Sulfate Autohaler
    Dosage: unknown amount
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-12-28

Palladone
    Dosage: unknown amount
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-12-28

Ceftriaxon
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-12-28

Pentaerythritol Tetranitate
    Dosage: one tablet
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-12-28

Amlodipine
    Dosage: one tablet
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-12-28



Possible Palladone side effects in male

Reported by a physician from Germany on 2012-01-04

Patient: male, weighing 90.0 kg (198.0 pounds)

Reactions: Hypotension, Somnolence, Accidental Exposure

Drug(s) suspected as cause:
Pentaerythritol Tetranitate
    Dosage: one tablet
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-12-28

Clarithromycin
    Dosage: one tablet
    Indication: Pneumonia
    Start date: 2011-12-28

Torsemide
    Dosage: one tablet
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-12-28

Plavix
    Dosage: one tablet
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-12-28

Albuterol Sulfate Autohaler
    Dosage: unknown amount
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-12-28

Amlodipine
    Dosage: one tablet
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-12-28

Ramipril
    Dosage: one tablet
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-12-28

Ceftriaxon
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-12-28

Aspirin
    Dosage: one tablet
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-12-28

Palladone
    Dosage: unknown amount
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-12-28



Possible Palladone side effects in 40 year old male

Reported by a physician from Germany on 2011-12-21

Patient: 40 year old male

Reactions: Arthralgia, Convulsion

Drug(s) suspected as cause:
Analgesics
    Indication: Product Used FOR Unknown Indication

Palladone
    Indication: Product Used FOR Unknown Indication

Hydromorphone HCL
    Indication: Product Used FOR Unknown Indication



Possible Palladone side effects in male

Reported by a physician from Germany on 2011-10-07

Patient: male

Reactions: Arthralgia, Convulsion

Drug(s) suspected as cause:
Hydromorphone HCL
    Indication: Product Used FOR Unknown Indication

Palladone
    Indication: Product Used FOR Unknown Indication

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