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Dopey (1)
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Roxanol Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 103 

Cardiac Arrest, Completed Suicide, Respiratory Arrest (6067781-5)
on Jan 16, 2009 Female from UNITED STATES , 58 years of age, was treated with Roxanol. Directly after, patient experienced the unwanted or unexpected Roxanol side effects: cardiac arrest, completed suicide, respiratory arrest. Roxanol dosage: Po.
Associated medications used:
  • Acetaminophen And Oxycodone Hcl (Po)
  • Pregabalin (Po)


Cardiac Arrest, Completed Suicide, Respiratory Arrest (6067780-3)
Patient was taking Roxanol. Patient felt the following Roxanol side effects: cardiac arrest, completed suicide, respiratory arrest on Jan 16, 2009 from UNITED STATES Additional patient health information: Female , 59 years of age, . Roxanol dosage: Po.
Multiple prescriptions taken:
  • Acetaminophen And Hydrocodone Bitartrate (Po)
  • Alprazolam (Po)
  • Diphenhydramine Hcl (Po)


Aspiration, Body Temperature Increased, Completed Suicide, Convulsion, Delirium, Electromechanical Dissociation, Flushing, Foreign Body Trauma (6066777-7)
Adverse event was reported on Jan 16, 2009 by a Female taking Roxanol (Dosage: N/A) . Location: UNITED STATES , 23 years of age, After Roxanol was administered, patient encountered several Roxanol side effects: aspiration, body temperature increased, completed suicide, convulsion, delirium, electromechanical dissociation, flushing, foreign body trauma.
Multiple concurrent drugs taken:
  • Methadone Hcl
  • Bupropion Hcl
  • Cocaine
  • Benzodiazepine
  • Quetiapine Fumarate
  • Cyclobenzaprine
  • Marijuana


Cardiac Arrest, Completed Suicide, Respiratory Arrest (6066772-8)
on Jan 16, 2009 Male from UNITED STATES , 43 years of age, was treated with Roxanol. Directly after, patient experienced the unwanted or unexpected Roxanol side effects: cardiac arrest, completed suicide, respiratory arrest. Roxanol dosage: ;po.
Associated medications used:
  • Amitriptyline Hcl (;po)
  • Lisinopril (;po)
  • Naproxen (;po)
  • Baclofen (;po)
  • Gabapentin (;po)
  • Venlafaxine Hcl (;po)
  • Ethanol (;po)



Completed Suicide (6066770-4)
on Jan 16, 2009 Female from UNITED STATES , 60 years of age, was treated with Roxanol. Patient felt the following Roxanol side effects: completed suicide. Roxanol dosage: ;po.
Multiple prescriptions taken:
  • Atenolol (;po)
  • Lorazepam (;po)


Cardiac Arrest, Completed Suicide, Respiratory Arrest (6066740-6)
Patient was taking Roxanol. After Roxanol was administered, patient encountered several Roxanol side effects: cardiac arrest, completed suicide, respiratory arrest on Jan 16, 2009 from UNITED STATES Additional patient health information: Male , 22 years of age, . Roxanol dosage: ;po.
Multiple concurrent drugs taken:
  • Acentaminophen/extromethorphan/doxylamine (;po)


Abdominal Pain Upper, Abnormal Behaviour, Arthralgia, Blood Albumin Decreased, Candidiasis, Cardio-respiratory Distress, Cerebrovascular Accident, Confusional State, Contusion (5842733-6)
Adverse event was reported on Jul 24, 2008 by a Male taking Roxanol (Dosage: N/A) . Location: UNITED STATES , 75 years of age, weighting 164.9 lb, Directly after, patient experienced the unwanted or unexpected Roxanol side effects: abdominal pain upper, abnormal behaviour, arthralgia, blood albumin decreased, candidiasis, cardio-respiratory distress, cerebrovascular accident, confusional state, contusion.
Associated medications used:
  • Rad001+ Erlotinib (30 Mg; Qw; Po)
  • Erlotinib (150 Mg; Qd; Po)
  • Klonopin
  • Norvasc
  • Prilosec
  • Senokot
  • Miralax
  • Reglan
Patient was hospitalized.

Homicide, Overdose (5701780-5)
on Mar 27, 2008 Male from UNITED STATES , 61 years of age, was treated with Roxanol. Patient felt the following Roxanol side effects: homicide, overdose. Roxanol dosage: N/A.

Blister, Feeling Abnormal, Hallucination, Nausea, Nightmare, Oedema Peripheral, Tremor, Urine Output Decreased, Vomiting (5623002-6)
on Jan 23, 2008 Male from UNITED STATES , 41 years of age, was diagnosed with
  • pain
and was treated with Roxanol. After Roxanol was administered, patient encountered several Roxanol side effects: blister, feeling abnormal, hallucination, nausea, nightmare, oedema peripheral, tremor, urine output decreased, vomiting. Roxanol dosage: 10 Mg;prn;po.
Multiple concurrent drugs taken:
  • Lithium Carbonate
  • Synthroid
  • Ativan
  • Bactrim
  • Lexapro
  • Valproic Acid
  • Vicodin
  • Dilantin


Completed Suicide (5613627-6)
Patient was taking Roxanol. Directly after, patient experienced the unwanted or unexpected Roxanol side effects: completed suicide on Jan 14, 2008 from UNITED STATES Additional patient health information: Female , 59 years of age, . Roxanol dosage: Po.
Associated medications used:
  • Lorazepam (Po)
  • Alprazolam (Po)
  • Meperidine (Po)


Cardiac Arrest, Completed Suicide, Respiratory Arrest (5613549-0)
Adverse event was reported on Jan 14, 2008 by a Male taking Roxanol (Dosage: ; Po) . Location: UNITED STATES , 33 years of age, Patient felt the following Roxanol side effects: cardiac arrest, completed suicide, respiratory arrest.
Multiple prescriptions taken:
  • Clonazepam (; Po)


(5613539-8)
on Jan 14, 2008 Female from UNITED STATES , 59 years of age, was treated with Roxanol. . Roxanol dosage: ; Po.
Multiple concurrent drugs taken:
  • Roxicodone (; Po)
  • Butalbital Acetaminophen And Caffeine (; Po)


Completed Suicide (5613538-6)
on Jan 14, 2008 Female from UNITED STATES , 50 years of age, was treated with Roxanol. Directly after, patient experienced the unwanted or unexpected Roxanol side effects: completed suicide. Roxanol dosage: ; Po.
Associated medications used:
  • Bupropion Hcl (; Po)
  • Cocaine (; Po)
  • Opioids/opioid Antagonist (; Po)
  • Antidepressants, Tricyclic (; Po)


Completed Suicide (5613537-4)
Patient was taking Roxanol. Patient felt the following Roxanol side effects: completed suicide on Jan 14, 2008 from UNITED STATES Additional patient health information: Female , 53 years of age, . Roxanol dosage: Po.
Multiple prescriptions taken:
  • Butalbital/aspirin/cafeine (Po)
  • Hydrochlorothiazide (Po)


Cardiac Arrest, Completed Suicide, Respiratory Arrest (5613153-4)
Adverse event was reported on Jan 14, 2008 by a Male taking Roxanol (Dosage: Po) . Location: UNITED STATES , 74 years of age, After Roxanol was administered, patient encountered several Roxanol side effects: cardiac arrest, completed suicide, respiratory arrest.
Multiple concurrent drugs taken:
  • Darvon (Po)
  • Oramorph Sr (Po)
  • Amitriptyline And Perphenazine (Po)
  • Venlafaxine Hcl (Po)
  • Clonazepam (Po)
  • L-dopa And Related (Po)
  • Acetaminophen (Po)


(5613152-2)
on Jan 14, 2008 Female from UNITED STATES , 39 years of age, was treated with Roxanol. . Roxanol dosage: Po.
Associated medications used:
  • Codeine Sul Tab (Po)


Cardiac Arrest, Respiratory Arrest (5613076-0)
on Jan 14, 2008 Female from UNITED STATES , 70 years of age, was treated with Roxanol. Patient felt the following Roxanol side effects: cardiac arrest, respiratory arrest. Roxanol dosage: Po.

Cardiac Arrest, Respiratory Arrest (5613069-3)
Patient was taking Roxanol. After Roxanol was administered, patient encountered several Roxanol side effects: cardiac arrest, respiratory arrest on Jan 14, 2008 from UNITED STATES Additional patient health information: Female , 46 years of age, . Roxanol dosage: Po.
Multiple concurrent drugs taken:
  • Darvocet-n 100 (Po)
  • Pregabalin (Po)
  • Clonazepam (Po)


Cardiac Arrest, Respiratory Arrest (5613068-1)
Adverse event was reported on Jan 14, 2008 by a Female taking Roxanol (Dosage: Po) . Location: UNITED STATES , 52 years of age, Directly after, patient experienced the unwanted or unexpected Roxanol side effects: cardiac arrest, respiratory arrest.
Associated medications used:
  • Losartin (Po)
  • Citalopram Hydrobromide (Po)
  • Bactrim (Po)


(5613067-X)
on Jan 14, 2008 Female from UNITED STATES , 50 years of age, was treated with Roxanol. . Roxanol dosage: Po.
Multiple prescriptions taken:
  • Benzodiazepine (Po)
  • Thiazolidenedione (Po)
  • Thyroid Preparation (Po)
  • Furosemide (Po)
  • Quinapril Hcl (Po)
  • Pravastatin (Po)
  • Pregabalin (Po)
  • Baclofen (Po)


Cardiac Arrest, Respiratory Arrest (5613066-8)
on Jan 14, 2008 Male from UNITED STATES , 52 years of age, was treated with Roxanol. After Roxanol was administered, patient encountered several Roxanol side effects: cardiac arrest, respiratory arrest. Roxanol dosage: Po.
Multiple concurrent drugs taken:
  • Amitriptyline Hcl (Po)
  • Diazepam (Po)
  • Naproxen (Po)


Cardiac Arrest, Completed Suicide, Respiratory Arrest (5613065-6)
Patient was taking Roxanol. Directly after, patient experienced the unwanted or unexpected Roxanol side effects: cardiac arrest, completed suicide, respiratory arrest on Jan 14, 2008 from UNITED STATES Additional patient health information: Female , 52 years of age, . Roxanol dosage: Po.
Associated medications used:
  • Cocaine (Po)


Cardiac Arrest, Respiratory Arrest (5613064-4)
Adverse event was reported on Jan 14, 2008 by a Male taking Roxanol (Dosage: N/A) . Location: UNITED STATES , 50 years of age, Patient felt the following Roxanol side effects: cardiac arrest, respiratory arrest.

Cardiac Arrest, Completed Suicide, Respiratory Arrest (5613059-0)
on Jan 14, 2008 Female from UNITED STATES , 43 years of age, was treated with Roxanol. After Roxanol was administered, patient encountered several Roxanol side effects: cardiac arrest, completed suicide, respiratory arrest. Roxanol dosage: Po.
Multiple concurrent drugs taken:
  • Methadone Hcl (Po)


(5613058-9)
on Jan 14, 2008 Male from UNITED STATES , 39 years of age, was treated with Roxanol. . Roxanol dosage: Po.
Associated medications used:
  • Alprazolam (Po)


Showing 1-25 of 103 

Roxanol Health Episodes

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Roxanol Information

More About Roxanol

Side Effects reported to FDA: 103. View Roxanol Adverse Reports

Roxanol safety alerts: 2003

Reported deaths: 64

Reported hospitalizations: 4

Roxanol (morphine sulfate) Concentrated Oral Solution

Audience: Pharmacists and other healthcare professionals

NOTE: A corrected "Dear Healthcare Professional" letter was issued October 22, 2003.

Elan Pharmaceuticals issued a "Dear Healthcare Professional" October 6, 2003 reporting serious adverse events and deaths resulting from accidental overdose of high concentration morphine sulfate oral solutions. In most of these cases, morphine oral solutions ordered in milligrams (mg) were mistakenly interchanged for milliliters (mL) of the product, resulting in 20-fold overdoses. Procedures for proper ordering and dispensing were included in the "Dear Healthcare Professional" letter.

UPDATE

[October 22, 2003 - Corrected Letter - Elan Pharmaceuticals] PDF Format
[June 13, 2003 - Letter - Elan Pharmaceuticals]

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