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Roxanol Side Effects

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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.

Roxanol Side Effects Reported to FDA



Roxanol Side Effect Report#8457300-8
Cardiac Failure Congestive
This is a report of a female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Roxanol (dosage: NA, start time:
Jan 01, 2012), combined with:
  • Adcirca (40 Mg, Qd)
  • Milk Of Magnesium
  • Tylenol /sch/
  • Ativan
and developed a serious reaction and side effect(s): Cardiac Failure Congestive after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Roxanol treatment in female patients, resulting in Cardiac Failure Congestive side effect.
Roxanol Side Effect Report#7692521-3
This report suggests a potential Roxanol Death side effect(s) that can have serious consequences. A 58-year-old male patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Roxanol (dosage: NA) starting
Jun 23, 2011. After starting Roxanol the patient began experiencing various side effects, including:Additional drugs used concurrently:
  • Haldol
  • Morphine
  • Phenergan Hcl
  • Zolinza
Although Roxanol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Death, may still occur.
Roxanol Side Effect Report#7620976-9
Arrhythmia, Renal Failure, Haematuria, Thrombocytopenia, Dehydration, Tumour Lysis Syndrome, Neutropenia
This Arrhythmia problem was reported by a physician from United States. A male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Oct 27, 2010 this consumer started treatment with Roxanol (dosage: Unk). The following drugs were being taken at the same time:
  • Clofarabine (25 Mg, Qdx5)
  • Sodium Bicarbonate
  • Vicodin (Unk)
  • Benadryl (Unk)
  • Acetaminophen (Unk)
  • Compazine (Unk)
When using Roxanol, the patient experienced the following unwanted symptoms/side effects: Arrhythmia, Renal Failure, Haematuria, Thrombocytopenia, Dehydration, Tumour Lysis Syndrome, NeutropeniaThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Arrhythmia, may become evident only after a product is in use by the general population.
Roxanol Side Effect Report#7306395-3
Cardiac Arrest, Completed Suicide, Respiratory Arrest
This Cardiac Arrest side effect was reported by a physician from United States. A 17-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Roxanol (drug dosage: Po), which was initiated on NS. Concurrently used drugs:
  • Marijuana
.After starting to take Roxanol the consumer reported adverse symptoms, such as: Cardiac Arrest, Completed Suicide, Respiratory ArrestThese side effects may potentially be related to Roxanol.
Roxanol Side Effect Report#7306361-8
Cardiac Arrest, Completed Suicide, Respiratory Arrest
This is a report of a 35-year-old male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Roxanol (dosage: Po, start time: NS), combined with:
  • Gabapentin (Po)
  • Roxicodone (Po)
and developed a serious reaction and side effect(s): Cardiac Arrest, Completed Suicide, Respiratory Arrest after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Roxanol treatment in male patients, resulting in Cardiac Arrest side effect.
Roxanol Side Effect Report#7299845-2
Respiratory Arrest, Cardiac Arrest, Completed Suicide
This report suggests a potential Roxanol Respiratory Arrest side effect(s) that can have serious consequences. A 51-year-old female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Roxanol (dosage: ; Po) starting NS. After starting Roxanol the patient began experiencing various side effects, including: Respiratory Arrest, Cardiac Arrest, Completed SuicideAdditional drugs used concurrently:
  • Simvastatin
  • Diphenhydramine Hcl
  • Tapazole
Although Roxanol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Respiratory Arrest, may still occur.
Roxanol Side Effect Report#7299840-3
Completed Suicide, Incorrect Dose Administered
This Completed Suicide problem was reported by a physician from United States. A 54-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Roxanol (dosage: Po). The following drugs were being taken at the same time:
  • Amitriptyline Hcl (Po)
  • Trazodone Hcl (Po)
When using Roxanol, the patient experienced the following unwanted symptoms/side effects: Completed Suicide, Incorrect Dose AdministeredAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Completed Suicide, may become evident only after a product is in use by the general population.
Roxanol Side Effect Report#6578665-8
Completed Suicide
This Completed Suicide side effect was reported by a physician from United States. A 55-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Roxanol (drug dosage: ; Po), which was initiated on NS. Concurrently used drugs:
  • Hydrocodone Bitartrate And Acetaminophen (; Po)
  • Carisoprodol (;po)
  • Alprazolam (; Po)
  • Zolpidem (;po)
.After starting to take Roxanol the consumer reported adverse symptoms, such as: Completed SuicideThese side effects may potentially be related to Roxanol.
Roxanol Side Effect Report#6578663-4
Completed Suicide
This is a report of a 53-year-old male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Roxanol (dosage: ;po, start time: NS), combined with:
  • Acetaminophen (; Po)
  • Phenobarbital Tab (;po)
  • Hydromorphone Hydrochloride (;po)
  • Carisoprodol (;po)
  • Diphenoxylate Hcl + Atropine Sulfate (;po)
and developed a serious reaction and side effect(s): Completed Suicide after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Roxanol treatment in male patients, resulting in Completed Suicide side effect.
Roxanol Side Effect Report#6578662-2
Cardiac Arrest, Completed Suicide, Respiratory Arrest
This report suggests a potential Roxanol Cardiac Arrest side effect(s) that can have serious consequences. A 53-year-old male patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Roxanol (dosage: Po) starting NS. After starting Roxanol the patient began experiencing various side effects, including: Cardiac Arrest, Completed Suicide, Respiratory ArrestAdditional drugs used concurrently: NA. Although Roxanol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cardiac Arrest, may still occur.
Roxanol Side Effect Report#6578657-9
Cardiac Arrest, Completed Suicide, Respiratory Arrest
This Cardiac Arrest problem was reported by a physician from United States. A 51-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Roxanol (dosage: Po). The following drugs were being taken at the same time:
  • Benzodiazepine (Po)
When using Roxanol, the patient experienced the following unwanted symptoms/side effects: Cardiac Arrest, Completed Suicide, Respiratory ArrestAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Cardiac Arrest, may become evident only after a product is in use by the general population.
Roxanol Side Effect Report#6575867-1
Cardiac Arrest, Completed Suicide, Respiratory Arrest
This Cardiac Arrest side effect was reported by a physician from United States. A 50-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Roxanol (drug dosage: Po), which was initiated on NS. Concurrently used drugs:
  • Benzodiazepine (Po)
.After starting to take Roxanol the consumer reported adverse symptoms, such as: Cardiac Arrest, Completed Suicide, Respiratory ArrestThese side effects may potentially be related to Roxanol.
Roxanol Side Effect Report#6575866-X
Cardiac Arrest, Respiratory Arrest
This is a report of a 41-year-old male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Roxanol (dosage: ; Po, start time: NS), combined with:
  • Ethanol (; Po)
  • Benzodiazepine (; Po)
  • Phenobarbital Tab (; Po)
and developed a serious reaction and side effect(s): Cardiac Arrest, Respiratory Arrest after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Roxanol treatment in male patients, resulting in Cardiac Arrest side effect.
Roxanol Side Effect Report#6575862-2
Alanine Aminotransferase Increased, Apnoea, Aspartate Aminotransferase Increased, Aspiration, Blood Bicarbonate Decreased, Blood Glucose Increased, Blood Potassium Increased, Body Temperature Decreased
This report suggests a potential Roxanol Alanine Aminotransferase Increased side effect(s) that can have serious consequences. A 51-year-old female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Roxanol (dosage: Po) starting NS. After starting Roxanol the patient began experiencing various side effects, including: Alanine Aminotransferase Increased, Apnoea, Aspartate Aminotransferase Increased, Aspiration, Blood Bicarbonate Decreased, Blood Glucose Increased, Blood Potassium Increased, Body Temperature DecreasedAdditional drugs used concurrently:
  • Benzodiazepine (Po)
  • Pregabalin (Po)
  • Duloxetine Hydrochloride (Po)
  • Hydrocodone Bitartrate And Acetaminophen
  • Topiramate
Although Roxanol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Alanine Aminotransferase Increased, may still occur.
Roxanol Side Effect Report#6575861-0
Completed Suicide
This Completed Suicide problem was reported by a physician from United States. A 81-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Roxanol (dosage: Po). The following drugs were being taken at the same time:
  • Diltiazem (Po)
  • Amiodarone (Po)
When using Roxanol, the patient experienced the following unwanted symptoms/side effects: Completed SuicideAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Completed Suicide, may become evident only after a product is in use by the general population.
Roxanol Side Effect Report#6575856-7
Cardiac Arrest, Completed Suicide, Respiratory Arrest
This Cardiac Arrest side effect was reported by a physician from United States. A 59-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Roxanol (drug dosage: Po), which was initiated on NS. Concurrently used drugs:
  • Roxicodone (Po)
.After starting to take Roxanol the consumer reported adverse symptoms, such as: Cardiac Arrest, Completed Suicide, Respiratory ArrestThese side effects may potentially be related to Roxanol.
Roxanol Side Effect Report#6575855-5
Completed Suicide
This is a report of a 59-year-old male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Roxanol (dosage: Po, start time: NS), combined with:
  • Diltiazem (Po)
  • Alprazolam (Po)
  • Esomeprazole (Po)
  • Sotalol (Po)
  • Salicylate (Po)
  • Hydromorphone Hydrochloride (Po)
and developed a serious reaction and side effect(s): Completed Suicide after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Roxanol treatment in male patients, resulting in Completed Suicide side effect.
Roxanol Side Effect Report#6575154-1
Cardiac Arrest, Completed Suicide, Poisoning, Respiratory Arrest
This report suggests a potential Roxanol Cardiac Arrest side effect(s) that can have serious consequences. A 44-year-old female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Roxanol (dosage: Po) starting NS. After starting Roxanol the patient began experiencing various side effects, including: Cardiac Arrest, Completed Suicide, Poisoning, Respiratory ArrestAdditional drugs used concurrently:
  • Trazodone (Po)
Although Roxanol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cardiac Arrest, may still occur.
Roxanol Side Effect Report#6575153-X
Cardiac Arrest, Completed Suicide, Poisoning, Respiratory Arrest
This Cardiac Arrest problem was reported by a physician from United States. A 28-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Roxanol (dosage: Po). The following drugs were being taken at the same time:
  • Acetaminophen (Po)
When using Roxanol, the patient experienced the following unwanted symptoms/side effects: Cardiac Arrest, Completed Suicide, Poisoning, Respiratory ArrestAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Cardiac Arrest, may become evident only after a product is in use by the general population.
Roxanol Side Effect Report#6067787-6
Cardiac Arrest, Completed Suicide, Respiratory Arrest
This Cardiac Arrest side effect was reported by a physician from United States. A 16-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Roxanol (drug dosage: Inh), which was initiated on NS. Concurrently used drugs: NA..After starting to take Roxanol the consumer reported adverse symptoms, such as: Cardiac Arrest, Completed Suicide, Respiratory ArrestThese side effects may potentially be related to Roxanol.
Roxanol Side Effect Report#6067786-4
Completed Suicide
This is a report of a 20-year-old male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Roxanol (dosage: NA, start time: NS), combined with:
  • Acetaminophen And Hydrocodone Bitartrate
  • Aspirin
  • Ethanol
and developed a serious reaction and side effect(s): Completed Suicide after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Roxanol treatment in male patients, resulting in Completed Suicide side effect.
Roxanol Side Effect Report#6067785-2
Cardiac Arrest, Completed Suicide, Respiratory Arrest
This report suggests a potential Roxanol Cardiac Arrest side effect(s) that can have serious consequences. A 44-year-old female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Roxanol (dosage: Po) starting NS. After starting Roxanol the patient began experiencing various side effects, including: Cardiac Arrest, Completed Suicide, Respiratory ArrestAdditional drugs used concurrently:
  • Alprazolam (Po)
  • Amitriptyline Hcl (Po)
Although Roxanol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cardiac Arrest, may still occur.
Roxanol Side Effect Report#6067784-0
Cardiac Arrest, Respiratory Arrest
This Cardiac Arrest problem was reported by a physician from United States. A 20-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Roxanol (dosage: Po). The following drugs were being taken at the same time:
  • Methadone Hcl (Po)
  • Morphine (Po)
When using Roxanol, the patient experienced the following unwanted symptoms/side effects: Cardiac Arrest, Respiratory ArrestAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Cardiac Arrest, may become evident only after a product is in use by the general population.
Roxanol Side Effect Report#6067783-9
Completed Suicide
This Completed Suicide side effect was reported by a physician from United States. A 49-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Roxanol (drug dosage: Po), which was initiated on NS. Concurrently used drugs:
  • Benzodiazepine (Po)
  • Temazepam (Po)
  • Alprazolam (Po)
  • Ethanol (Po)
  • Acetaminophen (Po)
  • Diazepam (Po)
.After starting to take Roxanol the consumer reported adverse symptoms, such as: Completed SuicideThese side effects may potentially be related to Roxanol.
Roxanol Side Effect Report#6067782-7
Cardiac Arrest, Completed Suicide, Respiratory Arrest
This is a report of a 50-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Roxanol (dosage: Po, start time: NS), combined with:
  • Diazepam (Po)
  • Gabapentin (Po)
  • Acetaminophen And Oxycodone Hcl (Po)
  • Hydromorphone Hcl (Po)
and developed a serious reaction and side effect(s): Cardiac Arrest, Completed Suicide, Respiratory Arrest after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Roxanol treatment in female patients, resulting in Cardiac Arrest side effect.


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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.

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Track Your Side Effects

Note Your Observations

It is really important to keep track of your health 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

    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.

    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 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.

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    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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    Roxanol 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]

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