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 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 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 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
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
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
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