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Novaminsulfon Side Effects

Common Novaminsulfon Side Effects


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

Liver Disorder (3)
Gamma-glutamyltransferase Increased (2)
Serotonin Syndrome (1)
Speech Disorder (1)
Sepsis (1)
Sudden Cardiac Death (1)
Mental Status Changes (1)
Acquired Diaphragmatic Eventration (1)
Loss Of Consciousness (1)
Lymph Node Tuberculosis (1)
Restlessness (1)
Post Procedural Complication (1)
Neoplasm (1)
Nausea (1)
Myocardial Infarction (1)
Oedema Peripheral (1)
Osteoarthritis (1)
Pneumonia (1)
Pancytopenia (1)
Pulmonary Tuberculosis (1)

➢ 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.

Novaminsulfon Side Effects Reported to FDA

The following Novaminsulfon 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 Novaminsulfon 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.
Agranulocytosis
This is a report of a 42-year-old female patient (weight: NA) from DE, suffering from the following symptoms/conditions: NA, who was treated with Novaminsulfon (dosage: 4 Gram Daily;, start time: Aug 11, 2013), combined with:
  • Pantoprazole (40 Milligram Daily;)
  • Pantoprazole (40 Milligram Daily;)
and developed a serious reaction and side effect(s). The consumer presented with:
  • Agranulocytosis
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Novaminsulfon treatment in female patients, resulting in agranulocytosis side effect.

Anaphylactic Reaction
This report suggests a potential Novaminsulfon Anaphylactic Reaction side effect(s) that can have serious consequences. A 44-year-old female patient (weight: NA) from DE was diagnosed with the following symptoms/conditions: NA and used Novaminsulfon (dosage: NA) starting Aug 23, 2011. Soon after starting Novaminsulfon the patient began experiencing various side effects, including:
  • Anaphylactic Reaction
Drugs used concurrently:
  • Prothyrid
  • Telfast
  • Levothyroxin (1-0-0)
  • Calcium Acetate (1-0-0)
  • Folsav (1.5-0-0)
  • Hydrochlorothiazide (If Needed)
  • Vitamin B12
  • Omalizumab (Date Of Most Recent Dose Prior To Sae : 10/jan/2012)
The patient was hospitalized. Although Novaminsulfon demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as anaphylactic reaction, may still occur.


This problem was reported by a physician from GERMANY. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: pain,cardiac failure,atrial fibrillation. On Oct 01, 2011 this consumer started treatment with Novaminsulfon (dosage: 500 Mg). The following drugs were being taken at the same time:
  • Torsemide (10 Mg)
  • Pradaxa (110 Mg)
  • Gingium
  • Metoprolol Succinate (47.5 Mg)
When commencing Novaminsulfon, the patient experienced the following unwanted symptoms/side effects:
    Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as death, may become evident only after a product is in use by the general population.

    Osteoarthritis
    This is a report of a male patient (weight: NA) from GERMANY. The patient developed the following symptoms/conditions: arthralgia,ulcer,diabetes mellitus and was treated with Novaminsulfon (dosage: 50 Mg, Qd) starting Jan 26, 2009. Concurrently used drugs:
    • Pantoprazole (20 Mg, Qd)
    • Actrapid (30 Iu, Qd)
    • Diclofenac (150 Mg, Qd)
    • Metformin Hcl (1700 Mg, Qd)
    • Oxazepam (10 Mg, Qd)
    • Torasemide (10 Mg, Qd)
    • Amlodipine (10 Mg, Qd)
    • Tamsulosin Hcl (0.4 Mg, Qd)
    Soon after that, the consumer experienced the following side effects:
    • Osteoarthritis
    The patient was hospitalized. This opens a possibility that Novaminsulfon treatment could cause the above reactions, including sudden cardiac death, and some male subjects may be more susceptible.


    Tinnitus
    A 22-year-old male patient (weight: NA) from GERMANY with the following symptoms/conditions: NA started Novaminsulfon treatment (dosage: NA) on NS. Soon after starting Novaminsulfon treatment, the subject experienced various side effects, including:
    • Tinnitus
    Concurrently used drugs:
    • Tramadol Hydrochloride
    • Ibuprofen
    This finding indicates that some male patients could be more vulnerable to Novaminsulfon.

    Acute Prerenal Failure, Cardiac Failure, Sepsis, Pneumonia, Pancytopenia
    A 74-year-old male patient from GERMANY (weight: NA) experienced symptoms, such as: NA and was treated with Novaminsulfon(dosage: NA). The treatment was initiated on Feb 15, 2011. After that a consumer reported the following side effect(s):
    • Acute Prerenal Failure
    • Cardiac Failure
    • Sepsis
    • Pneumonia
    • Pancytopenia
    Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Novaminsulfon efficacy:
    • Revlimid (25 Milligram)
    • Pegfilgrastim (6 Milligram)
    • Palladone
    • Revlimid (10 Milligram)
    • Biphosphonates
    • Ibandronate Sodium (6 Milligram)
    • Innohep (20000 Iu (international Unit))
    • Revlimid (15 Milligram)
    The patient was hospitalized.

    Intertrigo Candida, Oedema Peripheral
    In this report, Novaminsulfon was administered for the following condition: NA.A 51-year-old male consumer from GERMANY (weight: NA) started Novaminsulfon treatment (dosage: 1000) on Aug 25, 2010.Sometime after starting the treatment, the patient complained of the following side effect(s):
    • Intertrigo Candida
    • Oedema Peripheral
    A possible interaction with other drugs could have contributed to this reaction:
    • Pastacincimollissinelanol (Unk)
    • Palladone (8/16)
    • Omeprazole (80)
    • Lantus
    • Sorafenib (Unk)
    • Vergentan (Unk)
    • Clotrimazol (20 Mg)
    • Trimapenidat (Daily Dose 125 Mg)
    The patient was hospitalized.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Novaminsulfon treatment could be related to the listed above side effect(s).

    Neoplasm
    This is a report of the following Novaminsulfon side effect(s):
    • Neoplasm
    A male patient from GERMANY (weight: NA) presented with the following condition: pain,multiple sclerosis and received a treatment with Novaminsulfon (dosage: NA) starting: Dec 10, 2010.The following concurrently used drugs could have generated interactions:
    • Fty 720 (0.5 Mg, Qd)
    The patient was hospitalized.This report suggests that a Novaminsulfon treatment could be associated with the listed above side effect(s).

    Nausea, Intervertebral Disc Protrusion, Acquired Diaphragmatic Eventration, Blood Calcium Increased, Lymph Node Tuberculosis, Pulmonary Tuberculosis, Post Procedural Complication, Gamma-glutamyltransferase Increased, Blood Albumin Increased
    This Novaminsulfon report was submitted by a female consumer from GERMANY (weight: NA). The patient was diagnosed with: NA and Novaminsulfon was administered (dosage: NA) starting: Nov 26, 2009. The consumer developed a set of symptoms:
    • Nausea
    • Intervertebral Disc Protrusion
    • Acquired Diaphragmatic Eventration
    • Blood Calcium Increased
    • Lymph Node Tuberculosis
    • Pulmonary Tuberculosis
    • Post Procedural Complication
    • Gamma-glutamyltransferase Increased
    • Blood Albumin Increased
    Other drugs used simultaneously:
    • Certolizumab Pegol (certolizumab Pegol) (See Image)
    • Metex
    • Dekristol
    • Calcium W/vitamin D /00188401/
    • Ranitic
    • Diclofenac Sodium
    • Folic Acid
    • Sulfasalazan
    The patient was hospitalized and became disabled.Those unexpected symptoms could be linked to a Novaminsulfon treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

    Liver Disorder
    This is a report of a possible correlation between Novaminsulfon use and the following symptoms/side effect(s):
    • Liver Disorder
    which could contribute to an assessment of Novaminsulfon risk profile.A 33-year-old female consumer from GERMANY (weight: NA) was suffering from ankylosing spondylitis,hypothyroidism and was treated with Novaminsulfon (dosage: 500 Mg, ^if Required^) starting Nov 04, 2010.Other concurrent medications:
    • Thyroxin (100 A?g, Unk)
    • Etanercept (50 Mg, Qwk)


    Liver Disorder
    A 33-year-old female patient from GERMANY (weight: NA) presented with the following symptoms: ankylosing spondylitis,hypothyroidism and after a treatment with Novaminsulfon (dosage: 500 Mg, ^if Required^) experienced the following side effect(s):
    • Liver Disorder
    The treatment was started on Nov 04, 2010. Novaminsulfon was used in combination with the following drugs:
    • Thyroxin (100 A?g, Unk)
    • Etanercept (50 Mg, Qwk)
    This report could alert potential Novaminsulfon consumers.

    Gamma-glutamyltransferase Increased, Arthralgia
    In this report, a 73-year-old female patient from GERMANY (weight: NA) was affected by a possible Novaminsulfon side effect.The patient was diagnosed with NA. After a treatment with Novaminsulfon (dosage: NA, start date: Jun 01, 2010), the patient experienced the following side effect(s):
    • Gamma-glutamyltransferase Increased
    • Arthralgia
    The following simultaneously used drugs could have led to this reaction:
    • Leflunomide
    • Torasemid
    • Trazodon
    • Symbicort (160/4.5)
    • Decortin H
    • Omeprazole
    • Marcumar
    • Monoxidin
    The patient was hospitalized.The findings here stress that side effects should be taken into consideration when evaluating a Novaminsulfon treatment.

    Liver Disorder
    This is a report of a 33-year-old female patient from GERMANY (weight: NA), who used Novaminsulfon (dosage: 500 Mg, ^if Required^) for a treatment of ankylosing spondylitis,hypothyroidism. After starting a treatment on Nov 04, 2010, the patient experienced the following side effect(s):
    • Liver Disorder
    The following drugs could possibly have interacted with the Novaminsulfon treatment
    • Thyroxin (100 A?g, Unk)
    • Etanercept (50 Mg, Qwk)
    Taken together, these observations suggest that a Novaminsulfon treatment could be related to side effect(s), such as Liver Disorder.

    Myocardial Infarction, Blood Pressure Increased, Mental Status Changes, Restlessness, Confusional State, Loss Of Consciousness, Speech Disorder, Serotonin Syndrome, Anxiety
    This myocardial infarction side effect was reported by a physician from GERMANY. A female patient (weight:NA) experienced the following symptoms/conditions: NA. The patient was prescribed Novaminsulfon (dosage: NA), which was started on NS. Concurrently used drugs:
    • Ramipril Hct
    • Mirtazapin
    • Digitoxin
    • Lyrica
    • Metoprolol Succinate
    • Omeprazole
    • Pentaerythritol Tetranitrate
    • Lactulose
    When starting to take Novaminsulfon the consumer reported the following symptoms:
    • Myocardial Infarction
    • Blood Pressure Increased
    • Mental Status Changes
    • Restlessness
    • Confusional State
    • Loss Of Consciousness
    • Speech Disorder
    • Serotonin Syndrome
    • Anxiety
    The patient was hospitalized. These side effects may potentially be related to Novaminsulfon.



    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.


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    Novaminsulfon Safety Alerts, Active Ingredients, Usage Information

    More About Novaminsulfon

    Side Effects reported to FDA: 14

    Novaminsulfon safety alerts: No

    Reported deaths: 3

    Reported hospitalizations: 8

    Latest Novaminsulfon clinical trials

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