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Roxanol Side Effects

Common Roxanol Side Effects

The most commonly reported Roxanol side effects (click to view or check a box to report):

Respiratory Arrest (59)
Cardiac Arrest (58)
Completed Suicide (45)
Death (13)
Incorrect Dose Administered (4)
Heart Rate Increased (3)
Grimacing (3)
Heart Rate Decreased (3)
Overdose (3)
Oxygen Saturation Decreased (3)
Respiratory Rate Decreased (3)
Respiratory Rate Increased (3)
Pain (3)
Hypotension (2)
Hypertension (2)
Loss Of Consciousness (2)
Poisoning (2)
Respiratory Failure (2)
Pneumonia (2)
Nail Discolouration (2)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Roxanol Side Effects Reported to FDA

The following Roxanol reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Roxanol on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
Cardiac Failure Congestive
on Jun 18, 2012 Female from UNITED STATES , weighting 104.0 lb, was treated with Roxanol. Directly after, patient experienced the unwanted or unexpected Roxanol side effects: cardiac failure congestive. Roxanol dosage: N/A.
Associated medications used:
  • Adcirca (40 Mg, Qd)
  • Milk Of Magnesium
  • Tylenol /sch/
  • Ativan



Patient was taking Roxanol. on Aug 15, 2011 from UNITED STATES Additional patient health information: Male , 58 years of age, . Roxanol dosage: N/A.
Multiple prescriptions taken:
  • Haldol
  • Morphine
  • Phenergan Hcl
  • Zolinza


Arrhythmia, Renal Failure, Haematuria, Thrombocytopenia, Dehydration, Tumour Lysis Syndrome, Neutropenia
Adverse event was reported on Jul 07, 2011 by a Male taking Roxanol (Dosage: Unk) . Location: UNITED STATES , weighting 148.8 lb, After Roxanol was administered, patient encountered several Roxanol side effects: arrhythmia, renal failure, haematuria, thrombocytopenia, dehydration, tumour lysis syndrome, neutropenia.
Multiple concurrent drugs taken:
  • Clofarabine (25 Mg, Qdx5)
  • Sodium Bicarbonate
  • Vicodin (Unk)
  • Benadryl (Unk)
  • Acetaminophen (Unk)
  • Compazine (Unk)
Patient was hospitalized.

Cardiac Arrest, Completed Suicide, Respiratory Arrest
on Jan 24, 2011 Male from UNITED STATES , 17 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:
  • Marijuana



Cardiac Arrest, Completed Suicide, Respiratory Arrest
on Jan 24, 2011 Male from UNITED STATES , 35 years of age, was treated with Roxanol. Patient felt the following Roxanol side effects: cardiac arrest, completed suicide, respiratory arrest. Roxanol dosage: Po.
Multiple prescriptions taken:
  • Gabapentin (Po)
  • Roxicodone (Po)


Respiratory Arrest, Cardiac Arrest, Completed Suicide
Patient was taking Roxanol. After Roxanol was administered, patient encountered several Roxanol side effects: respiratory arrest, cardiac arrest, completed suicide on Jan 24, 2011 from UNITED STATES Additional patient health information: Female , 51 years of age, . Roxanol dosage: ; Po.
Multiple concurrent drugs taken:
  • Simvastatin
  • Diphenhydramine Hcl
  • Tapazole


Completed Suicide, Incorrect Dose Administered
Adverse event was reported on Jan 24, 2011 by a Female taking Roxanol (Dosage: Po) . Location: UNITED STATES , 54 years of age, Directly after, patient experienced the unwanted or unexpected Roxanol side effects: completed suicide, incorrect dose administered.
Associated medications used:
  • Amitriptyline Hcl (Po)
  • Trazodone Hcl (Po)


Completed Suicide
on Jan 18, 2010 Female from UNITED STATES , 55 years of age, was treated with Roxanol. Patient felt the following Roxanol side effects: completed suicide. Roxanol dosage: ; Po.
Multiple prescriptions taken:
  • Hydrocodone Bitartrate And Acetaminophen (; Po)
  • Carisoprodol (;po)
  • Alprazolam (; Po)
  • Zolpidem (;po)


Completed Suicide
on Jan 18, 2010 Male from UNITED STATES , 53 years of age, was treated with Roxanol. After Roxanol was administered, patient encountered several Roxanol side effects: completed suicide. Roxanol dosage: ;po.
Multiple concurrent drugs taken:
  • Acetaminophen (; Po)
  • Phenobarbital Tab (;po)
  • Hydromorphone Hydrochloride (;po)
  • Carisoprodol (;po)
  • Diphenoxylate Hcl + Atropine Sulfate (;po)


Cardiac Arrest, Completed Suicide, Respiratory Arrest
Patient was taking Roxanol. Directly after, patient experienced the unwanted or unexpected Roxanol side effects: cardiac arrest, completed suicide, respiratory arrest on Jan 18, 2010 from UNITED STATES Additional patient health information: Male , 53 years of age, . Roxanol dosage: Po.

Cardiac Arrest, Completed Suicide, Respiratory Arrest
Adverse event was reported on Jan 18, 2010 by a Female taking Roxanol (Dosage: Po) . Location: UNITED STATES , 51 years of age, Patient felt the following Roxanol side effects: cardiac arrest, completed suicide, respiratory arrest.
Multiple prescriptions taken:
  • Benzodiazepine (Po)


Cardiac Arrest, Completed Suicide, Respiratory Arrest
on Jan 18, 2010 Male from UNITED STATES , 50 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:
  • Benzodiazepine (Po)


Cardiac Arrest, Respiratory Arrest
on Jan 18, 2010 Male from UNITED STATES , 41 years of age, was treated with Roxanol. Directly after, patient experienced the unwanted or unexpected Roxanol side effects: cardiac arrest, respiratory arrest. Roxanol dosage: ; Po.
Associated medications used:
  • Ethanol (; Po)
  • Benzodiazepine (; Po)
  • Phenobarbital Tab (; Po)


Alanine Aminotransferase Increased, Apnoea, Aspartate Aminotransferase Increased, Aspiration, Blood Bicarbonate Decreased, Blood Glucose Increased, Blood Potassium Increased, Body Temperature Decreased
Patient was taking Roxanol. Patient felt the following Roxanol side effects: alanine aminotransferase increased, apnoea, aspartate aminotransferase increased, aspiration, blood bicarbonate decreased, blood glucose increased, blood potassium increased, body temperature decreased on Jan 18, 2010 from UNITED STATES Additional patient health information: Female , 51 years of age, . Roxanol dosage: Po.
Multiple prescriptions taken:
  • Benzodiazepine (Po)
  • Pregabalin (Po)
  • Duloxetine Hydrochloride (Po)
  • Hydrocodone Bitartrate And Acetaminophen
  • Topiramate


Completed Suicide
Adverse event was reported on Jan 18, 2010 by a Female taking Roxanol (Dosage: Po) . Location: UNITED STATES , 81 years of age, After Roxanol was administered, patient encountered several Roxanol side effects: completed suicide.
Multiple concurrent drugs taken:
  • Diltiazem (Po)
  • Amiodarone (Po)


Cardiac Arrest, Completed Suicide, Respiratory Arrest
on Jan 18, 2010 Male from UNITED STATES , 59 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:
  • Roxicodone (Po)


Completed Suicide
on Jan 18, 2010 Male from UNITED STATES , 59 years of age, was treated with Roxanol. Patient felt the following Roxanol side effects: completed suicide. Roxanol dosage: Po.
Multiple prescriptions taken:
  • Diltiazem (Po)
  • Alprazolam (Po)
  • Esomeprazole (Po)
  • Sotalol (Po)
  • Salicylate (Po)
  • Hydromorphone Hydrochloride (Po)


Cardiac Arrest, Completed Suicide, Poisoning, Respiratory Arrest
Patient was taking Roxanol. After Roxanol was administered, patient encountered several Roxanol side effects: cardiac arrest, completed suicide, poisoning, respiratory arrest on Jan 18, 2010 from UNITED STATES Additional patient health information: Female , 44 years of age, . Roxanol dosage: Po.
Multiple concurrent drugs taken:
  • Trazodone (Po)


Cardiac Arrest, Completed Suicide, Poisoning, Respiratory Arrest
Adverse event was reported on Jan 18, 2010 by a Male taking Roxanol (Dosage: Po) . Location: UNITED STATES , 28 years of age, Directly after, patient experienced the unwanted or unexpected Roxanol side effects: cardiac arrest, completed suicide, poisoning, respiratory arrest.
Associated medications used:
  • Acetaminophen (Po)


Cardiac Arrest, Completed Suicide, Respiratory Arrest
on Jan 16, 2009 Female from UNITED STATES , 16 years of age, was treated with Roxanol. Patient felt the following Roxanol side effects: cardiac arrest, completed suicide, respiratory arrest. Roxanol dosage: Inh.

Completed Suicide
on Jan 16, 2009 Male from UNITED STATES , 20 years of age, was treated with Roxanol. After Roxanol was administered, patient encountered several Roxanol side effects: completed suicide. Roxanol dosage: N/A.
Multiple concurrent drugs taken:
  • Acetaminophen And Hydrocodone Bitartrate
  • Aspirin
  • Ethanol


Cardiac Arrest, Completed Suicide, Respiratory Arrest
Patient was taking Roxanol. Directly after, patient experienced the unwanted or unexpected Roxanol side effects: cardiac arrest, completed suicide, respiratory arrest on Jan 16, 2009 from UNITED STATES Additional patient health information: Female , 44 years of age, . Roxanol dosage: Po.
Associated medications used:
  • Alprazolam (Po)
  • Amitriptyline Hcl (Po)


Cardiac Arrest, Respiratory Arrest
Adverse event was reported on Jan 16, 2009 by a Male taking Roxanol (Dosage: Po) . Location: UNITED STATES , 20 years of age, Patient felt the following Roxanol side effects: cardiac arrest, respiratory arrest.
Multiple prescriptions taken:
  • Methadone Hcl (Po)
  • Morphine (Po)


Completed Suicide
on Jan 16, 2009 Female from UNITED STATES , 49 years of age, was treated with Roxanol. After Roxanol was administered, patient encountered several Roxanol side effects: completed suicide. Roxanol dosage: Po.
Multiple concurrent drugs taken:
  • Benzodiazepine (Po)
  • Temazepam (Po)
  • Alprazolam (Po)
  • Ethanol (Po)
  • Acetaminophen (Po)
  • Diazepam (Po)


Cardiac Arrest, Completed Suicide, Respiratory Arrest
on Jan 16, 2009 Female from UNITED STATES , 50 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:
  • Diazepam (Po)
  • Gabapentin (Po)
  • Acetaminophen And Oxycodone Hcl (Po)
  • Hydromorphone Hcl (Po)


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Keep Track of Side Effects

Note Your Observations

It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:

     

    Side Effects

    Scale

    Date & Time

    Other Medicine(s) or Treatment(s)

     

     

     

     

    Scale: 1 = very mild to 10 = very bad


    Track Online

  • User Sign In
  • Register to track your side effects

  • 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.

    Discuss Roxanol Side Effects

    Did You Have a Roxanol Side Effect?

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    How Effective is Roxanol for You?

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    Effective
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    Safety Alerts, Active Ingredients, Usage Information

    More About Roxanol

    Side Effects reported to FDA: 103

    Roxanol safety alerts: 2003

    Reported deaths: 67

    Reported hospitalizations: 5

    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]

    Latest Roxanol clinical trials

    Roxanol Reviews

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