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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
This is a report of a female patient (weight: NA) from UNITED STATES, suffering from the following 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). The consumer presented with:
  • Cardiac Failure Congestive
which developed 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.


This report suggests a potential Roxanol 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. Soon after starting Roxanol the patient began experiencing various side effects, including:
    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.

    Arrhythmia, Renal Failure, Haematuria, Thrombocytopenia, Dehydration, Tumour Lysis Syndrome, Neutropenia
    This Arrhythmia, Renal Failure, Haematuria, Thrombocytopenia, Dehydration, Tumour Lysis Syndrome, Neutropenia 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 commencing Roxanol, the patient experienced the following unwanted symptoms/side effects:
    • Arrhythmia
    • Renal Failure
    • Haematuria
    • Thrombocytopenia
    • Dehydration
    • Tumour Lysis Syndrome
    • Neutropenia
    The 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.

    Cardiac Arrest, Completed Suicide, Respiratory Arrest
    This is a report of a 17-year-old male patient (weight: NA) from UNITED STATES. The patient developed the following symptoms/conditions: NA and was treated with Roxanol (dosage: Po) starting NS. Concurrently used drugs:
    • Marijuana
    Soon after that, the consumer experienced the following side effects:
    • Cardiac Arrest
    • Completed Suicide
    • Respiratory Arrest
    This opens a possibility that Roxanol treatment could cause the above reactions, including cardiac arrest, and some male subjects may be more susceptible.


    Cardiac Arrest, Completed Suicide, Respiratory Arrest
    A 35-year-old male patient (weight: NA) from UNITED STATES with the following symptoms/conditions: NA started Roxanol treatment (dosage: Po) on NS. Soon after starting Roxanol treatment, the subject experienced various side effects, including:
    • Cardiac Arrest
    • Completed Suicide
    • Respiratory Arrest
    Concurrently used drugs:
    • Gabapentin (Po)
    • Roxicodone (Po)
    This finding indicates that some male patients could be more vulnerable to Roxanol.

    Respiratory Arrest, Cardiac Arrest, Completed Suicide
    A 51-year-old female patient from UNITED STATES (weight: NA) experienced symptoms, such as: NA and was treated with Roxanol(dosage: ; Po). The treatment was initiated on NS. After that a consumer reported the following side effect(s):
    • Respiratory Arrest
    • Cardiac Arrest
    • Completed Suicide
    Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Roxanol efficacy:
    • Simvastatin
    • Diphenhydramine Hcl
    • Tapazole


    Completed Suicide, Incorrect Dose Administered
    In this report, Roxanol was administered for the following condition: NA.A 54-year-old female consumer from UNITED STATES (weight: NA) started Roxanol treatment (dosage: Po) on NS.Sometime after starting the treatment, the patient complained of the following side effect(s):
    • Completed Suicide
    • Incorrect Dose Administered
    A possible interaction with other drugs could have contributed to this reaction:
    • Amitriptyline Hcl (Po)
    • Trazodone Hcl (Po)
    Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Roxanol treatment could be related to the listed above side effect(s).

    Completed Suicide
    This is a report of the following Roxanol side effect(s):
    • Completed Suicide
    A 55-year-old female patient from UNITED STATES (weight: NA) presented with the following condition: NA and received a treatment with Roxanol (dosage: ; Po) starting: NS.The following concurrently used drugs could have generated interactions:
    • Hydrocodone Bitartrate And Acetaminophen (; Po)
    • Carisoprodol (;po)
    • Alprazolam (; Po)
    • Zolpidem (;po)
    This report suggests that a Roxanol treatment could be associated with the listed above side effect(s).

    Completed Suicide
    This Roxanol report was submitted by a 53-year-old male consumer from UNITED STATES (weight: NA). The patient was diagnosed with: NA and Roxanol was administered (dosage: ;po) starting: NS. The consumer developed a set of symptoms:
    • Completed Suicide
    Other drugs used simultaneously:
    • Acetaminophen (; Po)
    • Phenobarbital Tab (;po)
    • Hydromorphone Hydrochloride (;po)
    • Carisoprodol (;po)
    • Diphenoxylate Hcl + Atropine Sulfate (;po)
    Those unexpected symptoms could be linked to a Roxanol treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

    Cardiac Arrest, Completed Suicide, Respiratory Arrest
    This is a report of a possible correlation between Roxanol use and the following symptoms/side effect(s):
    • Cardiac Arrest
    • Completed Suicide
    • Respiratory Arrest
    which could contribute to an assessment of Roxanol risk profile.A 53-year-old male consumer from UNITED STATES (weight: NA) was suffering from NA and was treated with Roxanol (dosage: Po) starting NS.Other concurrent medications: NA.

    Cardiac Arrest, Completed Suicide, Respiratory Arrest
    A 51-year-old female patient from UNITED STATES (weight: NA) presented with the following symptoms: NA and after a treatment with Roxanol (dosage: Po) experienced the following side effect(s):
    • Cardiac Arrest
    • Completed Suicide
    • Respiratory Arrest
    The treatment was started on NS. Roxanol was used in combination with the following drugs:
    • Benzodiazepine (Po)
    This report could alert potential Roxanol consumers.

    Cardiac Arrest, Completed Suicide, Respiratory Arrest
    In this report, a 50-year-old male patient from UNITED STATES (weight: NA) was affected by a possible Roxanol side effect.The patient was diagnosed with NA. After a treatment with Roxanol (dosage: Po, start date: NS), the patient experienced the following side effect(s):
    • Cardiac Arrest
    • Completed Suicide
    • Respiratory Arrest
    The following simultaneously used drugs could have led to this reaction:
    • Benzodiazepine (Po)
    The findings here stress that side effects should be taken into consideration when evaluating a Roxanol treatment.

    Cardiac Arrest, Respiratory Arrest
    This is a report of a 41-year-old male patient from UNITED STATES (weight: NA), who used Roxanol (dosage: ; Po) for a treatment of NA. After starting a treatment on NS, the patient experienced the following side effect(s):
    • Cardiac Arrest
    • Respiratory Arrest
    The following drugs could possibly have interacted with the Roxanol treatment
    • Ethanol (; Po)
    • Benzodiazepine (; Po)
    • Phenobarbital Tab (; Po)
    Taken together, these observations suggest that a Roxanol treatment could be related to side effect(s), such as Cardiac Arrest, Respiratory Arrest.

    Alanine Aminotransferase Increased, Apnoea, Aspartate Aminotransferase Increased, Aspiration, Blood Bicarbonate Decreased, Blood Glucose Increased, Blood Potassium Increased, Body Temperature Decreased
    This alanine aminotransferase increased side effect was reported by a physician from UNITED STATES. A 51-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA. The patient was prescribed Roxanol (dosage: Po), which was started on NS. Concurrently used drugs:
    • Benzodiazepine (Po)
    • Pregabalin (Po)
    • Duloxetine Hydrochloride (Po)
    • Hydrocodone Bitartrate And Acetaminophen
    • Topiramate
    When starting to take Roxanol the consumer reported the following symptoms:
    • Alanine Aminotransferase Increased
    • Apnoea
    • Aspartate Aminotransferase Increased
    • Aspiration
    • Blood Bicarbonate Decreased
    • Blood Glucose Increased
    • Blood Potassium Increased
    • Body Temperature Decreased
    These side effects may potentially be related to Roxanol.

    Completed Suicide
    This is a Roxanol side effect report of a 81-year-old female patient (weight:NA) from UNITED STATES, suffering from the following symptoms/conditions: NA, who was treated with Roxanol (dosage:Po, start time: NS), combined with:
    • Diltiazem (Po)
    • Amiodarone (Po)
    , and developed a serious reaction and a completed suicide side effect. The patient presented with:
    • Completed Suicide
    which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Roxanol treatment in female patients suffering from NA, resulting in completed suicide.

    Cardiac Arrest, Completed Suicide, Respiratory Arrest
    This report suggests a potential Roxanol cardiac arrest side effect(s) that can have serious consequences. A 59-year-old male patient from UNITED STATES (weight:NA) was diagnosed with the following health condition(s): NA and used Roxanol (dosage: Po) starting NS. Soon after starting Roxanol the patient began experiencing various side effects, including:
    • Cardiac Arrest
    • Completed Suicide
    • Respiratory Arrest
    Drugs used concurrently:
    • Roxicodone (Po)
    Although Roxanol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as cardiac arrest, may still occur.

    Completed Suicide
    This completed suicide problem was reported by a physician from UNITED STATES. A 59-year-old male patient (weight: NA) was diagnosed with the following medical condition(s): NA.On NS a consumer started treatment with Roxanol (dosage: Po). The following drugs/medications were being taken at the same time:
    • Diltiazem (Po)
    • Alprazolam (Po)
    • Esomeprazole (Po)
    • Sotalol (Po)
    • Salicylate (Po)
    • Hydromorphone Hydrochloride (Po)
    When commencing Roxanol, the patient experienced the following unwanted symptoms /side effects:
    • Completed Suicide
    Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as completed suicide, may become evident only after a product is in use by the general population.

    Cardiac Arrest, Completed Suicide, Poisoning, Respiratory Arrest
    This is a Roxanol side effect report of a 44-year-old female patient (weight: NA) from UNITED STATES. The patient developed the following symptoms/conditions: NA and was treated with Roxanol (dosage: Po) starting NS. Concurrently used drugs:
    • Trazodone (Po)
    Soon after that, the consumer experienced the following of symptoms:
    • Cardiac Arrest
    • Completed Suicide
    • Poisoning
    • Respiratory Arrest
    This opens a possibility that Roxanol could cause cardiac arrest and that some female patients may be more susceptible.

    Cardiac Arrest, Completed Suicide, Poisoning, Respiratory Arrest
    A 28-year-old male patient (weight: NA) from UNITED STATES with the following symptoms: NA started Roxanol treatment (dosage: Po) on NS. Soon after starting Roxanol treatment, the consumer experienced several side effects, including:
    • Cardiac Arrest
    • Completed Suicide
    • Poisoning
    • Respiratory Arrest
    . Concurrently used drugs:
    • Acetaminophen (Po)
    This finding indicates that some patients can be more vulnerable to developing Roxanol side effects, such as cardiac arrest.

    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 (dosage: Inh), which was started on NS. Concurrently used drugs: NA..When starting to take Roxanol the consumer reported symptoms, such as:
    • Cardiac Arrest
    • Completed Suicide
    • Respiratory Arrest
    These side effects may potentially be related to Roxanol.

    Completed Suicide
    This is a report of a 20-year-old male patient (weight: NA) from UNITED STATES, suffering from the following 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). The consumer presented with:
    • Completed Suicide
    which developed 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.

    Cardiac Arrest, Completed Suicide, Respiratory Arrest
    This report suggests a potential Roxanol Cardiac Arrest, Completed Suicide, Respiratory 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. Soon after starting Roxanol the patient began experiencing various side effects, including:
    • Cardiac Arrest
    • Completed Suicide
    • Respiratory Arrest
    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.

    Cardiac Arrest, Respiratory Arrest
    This Cardiac Arrest, Respiratory 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 commencing Roxanol, the patient experienced the following unwanted symptoms/side effects:
    • Cardiac Arrest
    • Respiratory Arrest
    Although 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.

    Completed Suicide
    This is a report of a 49-year-old female patient (weight: NA) from UNITED STATES. The patient developed the following symptoms/conditions: NA and was treated with Roxanol (dosage: Po) starting NS. Concurrently used drugs:
    • Benzodiazepine (Po)
    • Temazepam (Po)
    • Alprazolam (Po)
    • Ethanol (Po)
    • Acetaminophen (Po)
    • Diazepam (Po)
    Soon after that, the consumer experienced the following side effects:
    • Completed Suicide
    This opens a possibility that Roxanol treatment could cause the above reactions, including completed suicide, and some female subjects may be more susceptible.

    Cardiac Arrest, Completed Suicide, Respiratory Arrest
    A 50-year-old female patient (weight: NA) from UNITED STATES with the following symptoms/conditions: NA started Roxanol treatment (dosage: Po) on NS. Soon after starting Roxanol treatment, the subject experienced various side effects, including:
    • Cardiac Arrest
    • Completed Suicide
    • Respiratory Arrest
    Concurrently used drugs:
    • Diazepam (Po)
    • Gabapentin (Po)
    • Acetaminophen And Oxycodone Hcl (Po)
    • Hydromorphone Hcl (Po)
    This finding indicates that some female patients could be more vulnerable to Roxanol.

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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

    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

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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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