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Roxanol Side Effects

Report Roxanol Side Effects

If you experienced any harmful or unwanted effects of Roxanol, please share your experience. This could help to raise awareness about Roxanol side effects, identify uknown risks and inform health professionals and patients taking Roxanol.

Examples: headache, dizziness


The most commonly reported Roxanol side effects are:
Blister (2 reports)
Sleepy (2 reports)
Dopey (1 reports)
Dopey, Sleepy (1 reports)

If you have experienced a side effect listed above, you can check a box to report it.


To view a complete list of submitted side effects, please follow the link Roxanol side effects . You can also compare Roxanol side effects or view FDA reports.

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).
The 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 identified a causal relationship between the drug and the listed risk.

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Cardiac Arrest, Completed Suicide, Respiratory Arrest
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:

Cardiac Arrest, Completed Suicide, Respiratory Arrest
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:

Aspiration, Body Temperature Increased, Completed Suicide, Convulsion, Delirium, Electromechanical Dissociation, Flushing, Foreign Body Trauma
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
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
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:

Cardiac Arrest, Completed Suicide, Respiratory Arrest
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:

Abdominal Pain Upper, Abnormal Behaviour, Arthralgia, Blood Albumin Decreased, Candidiasis, Cardio-respiratory Distress, Cerebrovascular Accident, Confusional State, Contusion
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: Patient was hospitalized.

Homicide, Overdose
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
on Jan 23, 2008 Male from UNITED STATES , 41 years of age, was diagnosed with 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:

Completed Suicide
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
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:


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
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
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:

Cardiac Arrest, Completed Suicide, Respiratory Arrest
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)



on Jan 14, 2008 Female from UNITED STATES , 39 years of age, was treated with Roxanol. . Roxanol dosage: Po.
Associated medications used:

Cardiac Arrest, Respiratory Arrest
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
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:

Cardiac Arrest, Respiratory Arrest
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)



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
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:

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 14, 2008 from UNITED STATES Additional patient health information: Female , 52 years of age, . Roxanol dosage: Po.
Associated medications used:

Cardiac Arrest, Respiratory Arrest
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
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:


on Jan 14, 2008 Male from UNITED STATES , 39 years of age, was treated with Roxanol. . Roxanol dosage: Po.
Associated medications used:

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Record and Track Your Side Effects

It is very important to keep track of all side effects and discuss them with your doctor. If you think you may have a medical emergency, call your doctor or 911 immediately.

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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.

Tips for Taking Medicines Properly

Before Taking Roxanol

Find Out How to Take Roxanol

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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JustAnswer.com

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

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