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Embeda (Morphine / Naltrexone) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Embeda (Morphine / Naltrexone) 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 (25)
Death (2)
Life Threatening Events (3)
Disability (2)

Reports by Reaction Type

Intentional Overdose (4)Migraine (4)Drug Ineffective (3)Pain (3)Convulsion (3)Pruritus (2)Lymphoma Operation (2)Speech Disorder (2)Completed Suicide (2)Posterior Reversible Encephalopathy Syndrome (2)Brain Oedema (2)Musculoskeletal Stiffness (2)

Possible Embeda side effects in female

Reported by a physician from United States on 2012-07-11

Patient: female, weighing 41.7 kg (91.8 pounds)

Reactions: Migraine, Myalgia, Myositis, Musculoskeletal Stiffness, Lower Limb Fracture

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Embeda
    Indication: Myositis

Embeda
    Indication: Back Pain

Embeda
    Dosage: unk, 1x/day
    Administration route: Oral
    Indication: Migraine
    Start date: 2009-01-01
    End date: 2009-01-01

Embeda
    Indication: Pain

Other drugs received by patient: Zoloft



Possible Embeda side effects in male

Reported by a individual with unspecified qualification from United States on 2012-06-29

Patient: male, weighing 99.3 kg (218.5 pounds)

Reactions: Intentional Overdose, Adverse Drug Reaction, Completed Suicide

Adverse event resulted in: death

Drug(s) suspected as cause:
Avinza
    Dosage: 60 mg, 1x/day
    Administration route: Oral
    Start date: 2009-09-24
    End date: 2009-09-27

Avinza
    Dosage: 60 mg, 2x/day
    Administration route: Oral
    Indication: Back Pain
    Start date: 2009-09-28

Embeda
    Dosage: 60 mg, 2x/day
    Administration route: Oral
    Indication: Back Pain
    Start date: 2009-09-28

Other drugs received by patient: Alprazolam; Advair Diskus 100 / 50; Seroquel; Lomotil; Lithium; Nexium; Albuterol; Cyclobenzaprine Hydrochloride; Neurontin; Clarinex; Cymbalta; Oxycodone and Acetaminophen; Allegra-D 12 Hour; Benzonatate; Ibuprofen; Fluticasone



Possible Embeda side effects in 60 year old male

Reported by a consumer/non-health professional from United States on 2012-06-29

Patient: 60 year old male

Reactions: Cardio-Respiratory Arrest, Intentional Overdose, Completed Suicide, Coma, Sluggishness, Convulsion

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Embeda

Other drugs received by patient: Lortab; Diazepam; Acetylsalicylic Acid / Carisoprodol / Codeine Phosphate; Pregabalin; Ambien; Hydromorphone



Possible Embeda side effects in 77 year old male

Reported by a physician from United States on 2012-06-28

Patient: 77 year old male

Reactions: Pneumonia, Overdose, Unresponsive To Stimuli

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Embeda
    Dosage: 150 mg, single
    Indication: Pain
    Start date: 2010-06-01

Embeda
    Dosage: 50 mg am and 30 mg pm

Embeda
    Dosage: 40 mg, 2x/day

Embeda
    Dosage: 20 mg, 2x/day



Possible Embeda side effects in female

Reported by a physician from United States on 2012-06-28

Patient: female

Reactions: Intentional Overdose, Suicide Attempt

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Embeda

Other drugs received by patient: Milnacipran (Sevella); Oxycodone Hydrochloride; Flexeril; Klonopin



Possible Embeda side effects in male

Reported by a individual with unspecified qualification from United States on 2012-06-28

Patient: male

Reactions: Cyanosis, Intentional Overdose, Coma, Respiratory Depression, Drug Abuse

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Embeda



Possible Embeda side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-05

Patient: female, weighing 86.6 kg (190.6 pounds)

Reactions: Concussion, Fatigue, Head Injury, Drug Ineffective, Fall

Drug(s) suspected as cause:
Embeda



Possible Embeda side effects in 56 year old male

Reported by a consumer/non-health professional from United States on 2012-06-04

Patient: 56 year old male

Reactions: Pruritus

Drug(s) suspected as cause:
Embeda



Possible Embeda side effects in female

Reported by a consumer/non-health professional from United States on 2012-04-26

Patient: female, weighing 41.7 kg (91.8 pounds)

Reactions: Myositis, Migraine, Myalgia, Musculoskeletal Stiffness, Lower Limb Fracture

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Embeda
    Dosage: unk, 1x/day
    Administration route: Oral
    Indication: Migraine
    Start date: 2009-01-01
    End date: 2009-01-01

Embeda
    Indication: Myositis

Embeda
    Indication: Back Pain

Embeda
    Indication: Pain

Other drugs received by patient: Zoloft



Possible Embeda side effects in 41 year old female

Reported by a consumer/non-health professional from United States on 2012-03-28

Patient: 41 year old female, weighing 100.0 kg (220.0 pounds)

Reactions: Withdrawal Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Embeda
    Dosage: unk
    Administration route: Oral
    Indication: Fibromyalgia
    End date: 2011-03-01

Embeda
    Indication: Back Pain

Morphine Sulfate
    Dosage: unk
    Start date: 2011-03-22

Naltrexone HCL
    Indication: Back Pain

Naltrexone HCL
    Dosage: unk
    Indication: Fibromyalgia
    Start date: 2011-03-22



Possible Embeda side effects in female

Reported by a physician from United States on 2012-03-09

Patient: female, weighing 59.0 kg (129.8 pounds)

Reactions: Lymphoma Operation

Drug(s) suspected as cause:
Embeda

Other drugs received by patient: Oxycontin



Possible Embeda side effects in 41 year old female

Reported by a consumer/non-health professional from United States on 2012-02-21

Patient: 41 year old female, weighing 100.0 kg (220.0 pounds)

Reactions: Withdrawal Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Embeda
    Indication: Back Pain

Embeda
    Dosage: unk
    Administration route: Oral
    Indication: Fibromyalgia
    End date: 2011-03-01

Morphine Sulfate
    Dosage: unk
    Indication: Fibromyalgia
    Start date: 2011-03-22

Morphine Sulfate
    Indication: Back Pain

Naltrexone Hydrochloride
    Dosage: unk
    Indication: Fibromyalgia
    Start date: 2011-03-22

Naltrexone Hydrochloride
    Indication: Back Pain



Possible Embeda side effects in 41 year old female

Reported by a consumer/non-health professional from United States on 2012-02-21

Patient: 41 year old female, weighing 99.8 kg (219.5 pounds)

Reactions: Drug Withdrawal Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Embeda
    Dosage: unk
    Administration route: Oral
    Indication: Fibromyalgia
    End date: 2011-03-01

Embeda
    Indication: Back Pain

Morphine Sulfate
    Dosage: unk
    Indication: Fibromyalgia
    Start date: 2011-03-22

Morphine Sulfate
    Indication: Back Pain

Naltrexone Hydrochloride
    Indication: Back Pain

Naltrexone Hydrochloride
    Dosage: unk
    Indication: Fibromyalgia
    Start date: 2011-03-22



Possible Embeda side effects in 41 year old female

Reported by a consumer/non-health professional from United States on 2012-02-17

Patient: 41 year old female, weighing 99.8 kg (219.5 pounds)

Reactions: Drug Withdrawal Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Embeda
    Dosage: unk
    Administration route: Oral
    Indication: Fibromyalgia
    End date: 2011-03-01

Embeda
    Indication: Back Pain

Morphine Sulfate
    Indication: Back Pain

Morphine Sulfate
    Dosage: unk
    Indication: Fibromyalgia
    Start date: 2011-03-22

Naltrexone
    Dosage: unk
    Indication: Fibromyalgia
    Start date: 2011-03-22

Naltrexone
    Indication: Back Pain



Possible Embeda side effects in male

Reported by a consumer/non-health professional from United States on 2012-02-08

Patient: male, weighing 86.2 kg (189.6 pounds)

Reactions: Blood Pressure Increased

Drug(s) suspected as cause:
Atenolol
    Dosage: 50 mg, unk
    Administration route: Oral
    Indication: Hypertension

Embeda
    Dosage: 60 unk, unk

Embeda
    Dosage: 80 mg, unk

Lisinopril
    Dosage: 20 mg, unk
    Administration route: Oral
    Indication: Hypertension

Norvasc
    Dosage: 10 mg, unk
    Administration route: Oral
    Indication: Hypertension



Possible Embeda side effects in female

Reported by a consumer/non-health professional from United States on 2012-01-04

Patient: female, weighing 59.0 kg (129.7 pounds)

Reactions: Lymphoma Operation

Drug(s) suspected as cause:
Embeda

Other drugs received by patient: Oxycontin



Possible Embeda side effects in female

Reported by a physician from United States on 2011-12-21

Patient: female, weighing 74.8 kg (164.6 pounds)

Reactions: Libido Decreased

Drug(s) suspected as cause:
Embeda
    Dosage: 20 mg, daily
    Administration route: Oral
    Indication: Anxiety
    Start date: 2010-04-01
    End date: 2010-07-01

Embeda
    Indication: Depression

Pristiq
    Indication: Depression

Pristiq
    Dosage: 150 mg, daily
    Administration route: Oral
    Indication: Anxiety
    Start date: 2011-02-01

Risperdal
    Indication: Depression

Risperdal
    Dosage: 4 mg, daily
    Administration route: Oral
    Indication: Anxiety
    Start date: 2010-07-01
    End date: 2011-02-01

Seroquel
    Indication: Depression

Seroquel
    Dosage: 600 mg, daily
    Administration route: Oral
    Indication: Anxiety

Zoloft
    Dosage: 100 mg, daily
    Administration route: Oral
    Indication: Anxiety
    Start date: 2009-11-01

Zoloft
    Indication: Depression

Other drugs received by patient: Atenolol; Pravastatin



Possible Embeda side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-16

Patient: male, weighing 85.0 kg (187.0 pounds)

Reactions: Migraine, Drug Ineffective, Epilepsy, Amnesia, Convulsion, Loss of Consciousness, Speech Disorder, Renal Failure, Posterior Reversible Encephalopathy Syndrome, Brain Oedema, Depression, Disability

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Embeda
    Dosage: 60 mg, 1x/day
    Indication: Neck Pain
    Start date: 2010-12-01
    End date: 2011-03-01

Embeda
    Dosage: 80 mg, 1x/day
    Administration route: Oral
    Indication: Back Pain
    Start date: 2011-03-04

Embeda
    Indication: Arthritis

Other drugs received by patient: Lantus; Amlodipine; Lisinopril; Atenolol; Glipizide; Topamax



Possible Embeda side effects in female

Reported by a consumer/non-health professional from United States on 2011-12-06

Patient: female, weighing 74.8 kg (164.6 pounds)

Reactions: Libido Decreased

Drug(s) suspected as cause:
Embeda
    Dosage: 20 mg, daily
    Administration route: Oral
    Indication: Anxiety
    Start date: 2010-04-01
    End date: 2010-07-01

Embeda
    Indication: Depression

Pristiq
    Dosage: 150 mg, daily
    Administration route: Oral
    Indication: Anxiety
    Start date: 2011-02-01

Pristiq
    Indication: Depression

Risperdal
    Indication: Depression

Risperdal
    Dosage: 4 mg, daily
    Administration route: Oral
    Indication: Anxiety
    Start date: 2010-07-01
    End date: 2011-02-01

Seroquel
    Indication: Depression

Seroquel
    Dosage: 600 mg, daily
    Administration route: Oral
    Indication: Anxiety

Zoloft
    Dosage: 100 mg, daily
    Administration route: Oral
    Indication: Anxiety
    Start date: 2009-11-01

Zoloft
    Indication: Depression

Other drugs received by patient: Pravastatin; Atenolol



Possible Embeda side effects in

Reported by a consumer/non-health professional from United States on 2011-11-22

Patient:

Reactions: Pain

Drug(s) suspected as cause:
Embeda
    Dosage: 100 mg, 3x/day
    Administration route: Oral
    Indication: Pain
    End date: 2011-03-01

Embeda
    Indication: Spinal Operation



Possible Embeda side effects in male

Reported by a consumer/non-health professional from United States on 2011-11-22

Patient: male, weighing 87.1 kg (191.6 pounds)

Reactions: Bone Pain, Pain, Feeling Abnormal, Crying

Drug(s) suspected as cause:
Embeda
    Indication: Spinal Operation

Embeda
    Dosage: 100 mg, 3x/day
    Administration route: Oral
    Indication: Pain
    Start date: 2010-01-01
    End date: 2011-03-01

Other drugs received by patient: Xanax



Possible Embeda side effects in male

Reported by a consumer/non-health professional from United States on 2011-11-01

Patient: male, weighing 86.2 kg (189.6 pounds)

Reactions: Blood Pressure Increased

Drug(s) suspected as cause:
Atenolol
    Dosage: 50 mg, unk
    Administration route: Oral
    Indication: Hypertension

Embeda
    Dosage: 60 unk, unk

Embeda
    Dosage: 80 mg, unk

Lisinopril
    Dosage: 20 mg, unk
    Administration route: Oral
    Indication: Hypertension

Norvasc
    Dosage: 10 mg, unk
    Administration route: Oral
    Indication: Hypertension



Possible Embeda side effects in 51 year old female

Reported by a consumer/non-health professional from United States on 2011-10-18

Patient: 51 year old female

Reactions: Rash Generalised, Dyspnoea, Hypersensitivity, Chest Discomfort, Pruritus, Nausea, Headache, Tremor, Insomnia, DRY Mouth, Nervous System Disorder, Vision Blurred

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Embeda

Other drugs received by patient: Topamax; Levothyroxine Sodium



Possible Embeda side effects in male

Reported by a consumer/non-health professional from United States on 2011-10-17

Patient: male, weighing 84.8 kg (186.6 pounds)

Reactions: Migraine, Drug Ineffective, Amnesia, Epilepsy, Convulsion, Loss of Consciousness, Speech Disorder, Renal Failure, Posterior Reversible Encephalopathy Syndrome, Brain Oedema, Depression, Disability

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Embeda
    Dosage: 60 mg, qd
    Indication: Neck Pain
    Start date: 2010-12-01
    End date: 2011-03-01

Embeda
    Dosage: 80 mg, qd
    Administration route: Oral
    Indication: Back Pain
    Start date: 2011-03-04

Embeda
    Indication: Arthritis

Other drugs received by patient: Atenolol; Amlodipine; Topamax; Lisinopril; Glipizide; Lantus



Possible Embeda side effects in

Reported by a consumer/non-health professional from United States on 2011-10-17

Patient:

Reactions: Pain, Suicidal Ideation

Drug(s) suspected as cause:
Embeda

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