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

 
 



Index of reports > All Cases (25)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Embeda (Morphine / Naltrexone) all cases. The selected reports were submitted to the FDA during the sample period of about a year.

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 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 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 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 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 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 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 2012-02-21

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 2012-02-17

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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