Common Modulen Side Effects

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

Bacterial Test Positive (1)
Anaphylactic Reaction (1)
Anaemia (1)
Throat Irritation (1)
Chest Discomfort (1)
Crohn's Disease (1)
Tachycardia (1)
Infusion Related Reaction (1)
Diarrhoea (1)
Abdominal Pain (1)

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.

Modulen Side Effects Reported to FDA

Modulen Side Effect Report#8002479-5
Chest Discomfort, Throat Irritation, Infusion Related Reaction, Tachycardia, Anaphylactic Reaction
This is a report of a male patient (weight: NA) from France, suffering from the following health symptoms/conditions: NA, who was treated with Modulen (dosage: NA, start time:
Mar 01, 2010), combined with:
  • Prednisone Tab
  • Remicade
  • Iron Sucrose
  • Remicade
  • Azathioprine
  • Omeprazole
  • Remicade
and developed a serious reaction and side effect(s): Chest Discomfort, Throat Irritation, Infusion Related Reaction, Tachycardia, Anaphylactic Reaction after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Modulen treatment in male patients, resulting in Chest Discomfort side effect.
Modulen Side Effect Report#7594781-6
Crohn's Disease
This report suggests a potential Modulen Crohn's Disease side effect(s) that can have serious consequences. A female patient (weight: NA) from United Kingdom was diagnosed with the following symptoms/conditions: NA and used Modulen (dosage: NA) starting
Dec 08, 2008. After starting Modulen the patient began experiencing various side effects, including: Crohn's DiseaseAdditional drugs used concurrently:
  • Remicade
  • Azathioprine
  • Scopolamine
  • Ondansetron
  • Morphine
  • Humira
  • Remicade
  • Omeprazole
The patient was hospitalized. Although Modulen demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Crohn's Disease, may still occur.
Modulen Side Effect Report#7220344-8
Abdominal Pain, Anaemia, Bacterial Test Positive, Diarrhoea
This Abdominal Pain problem was reported by a consumer or non-health professional from Brazil. A male patient (weight: NA) was diagnosed with the following symptoms/conditions: malnutrition. On
May 21, 2009 this consumer started treatment with Modulen (dosage: NA). The following drugs were being taken at the same time:
  • Humira
  • Humira (Loading Dose 80mg)
  • Phenytoin
  • Humira (Loading Dose 180mg)
When using Modulen, the patient experienced the following unwanted symptoms/side effects: Abdominal Pain, Anaemia, Bacterial Test Positive, DiarrhoeaThe 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 Abdominal Pain, may become evident only after a product is in use by the general population.

The appearance of Modulen 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.

What are common Modulen Side Effects for Women?

Women Side Effects Reports
Crohn's Disease 1

What are common Modulen Side Effects for Men?

Men Side Effects Reports
Abdominal Pain 1
Anaemia 1
Anaphylactic Reaction 1
Bacterial Test Positive 1
Chest Discomfort 1
Diarrhoea 1
Infusion Related Reaction 1
Tachycardia 1
Throat Irritation 1

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.

    Modulen 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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    More About Modulen

    Side Effects reported to FDA: 3

    Modulen safety alerts: No

    Reported hospitalizations: 2

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