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Enantyum Side Effects

Common Enantyum Side Effects


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

Asthenia (3)
Diarrhoea (2)
Anaemia (2)
Disease Progression (2)
Death (2)
Hypertransaminasaemia (2)
Renal Cell Carcinoma (2)
Renal Failure Acute (2)
Metrorrhagia (1)
Pneumonitis (1)
Lower Limb Fracture (1)
Hyperkalaemia (1)
Pseudomembranous Colitis (1)
Hand Fracture (1)
Speech Disorder (1)
Respiratory Failure (1)
Spinal Cord Compression (1)
Transaminases Increased (1)
Urinary Tract Infection (1)
Urosepsis (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.

Enantyum Side Effects Reported to FDA

The following Enantyum 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 Enantyum 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.
Diarrhoea, Hypertransaminasaemia, Disease Progression, Renal Cell Carcinoma, Anaemia, Asthenia
This is a report of a 65-year-old female patient (weight: NA) from SPAIN, suffering from the following symptoms/conditions: NA, who was treated with Enantyum (dosage: Unk, start time: Apr 01, 2011), combined with:
  • Torisel (Unk)
  • Tramadol Hcl (Unk)
and developed a serious reaction and side effect(s). The consumer presented with:
  • Diarrhoea
  • Hypertransaminasaemia
  • Disease Progression
  • Renal Cell Carcinoma
  • Anaemia
  • Asthenia
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Enantyum treatment in female patients, resulting in diarrhoea side effect.

Renal Cell Carcinoma, Disease Progression, Anaemia, Diarrhoea, Hypertransaminasaemia, Asthenia
This report suggests a potential Enantyum Renal Cell Carcinoma, Disease Progression, Anaemia, Diarrhoea, Hypertransaminasaemia, Asthenia side effect(s) that can have serious consequences. A 65-year-old female patient (weight: NA) from SPAIN was diagnosed with the following symptoms/conditions: NA and used Enantyum (dosage: NA) starting Apr 01, 2011. Soon after starting Enantyum the patient began experiencing various side effects, including:
  • Renal Cell Carcinoma
  • Disease Progression
  • Anaemia
  • Diarrhoea
  • Hypertransaminasaemia
  • Asthenia
Drugs used concurrently:
  • Tramadol Hcl
  • Torisel (Unk)
Although Enantyum demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as renal cell carcinoma, may still occur.

Lower Limb Fracture, Hand Fracture, Fall
This Lower Limb Fracture, Hand Fracture, Fall problem was reported by a consumer or non-health professional from ARGENTINA. A 63-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On Feb 12, 2008 this consumer started treatment with Enantyum (dosage: Unk). The following drugs were being taken at the same time:
  • Enbrel (50 Mg, Weekly)
When commencing Enantyum, the patient experienced the following unwanted symptoms/side effects:
  • Lower Limb Fracture
  • Hand Fracture
  • Fall
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as lower limb fracture, may become evident only after a product is in use by the general population.

Metrorrhagia
This is a report of a female patient (weight: NA) from SPAIN. The patient developed the following symptoms/conditions: pain,blood cholesterol,abdominal pain upper,depression,rheumatoid arthritis and was treated with Enantyum (dosage: NA) starting Sep 19, 2009. Concurrently used drugs:
  • Zocor
  • Omeprazole
  • Esertia
  • Tocilizumab
  • Prednisone
Soon after that, the consumer experienced the following side effects:
  • Metrorrhagia
This opens a possibility that Enantyum treatment could cause the above reactions, including metrorrhagia, and some female subjects may be more susceptible.


Renal Failure Acute, Vomiting, Urinary Tract Infection, Hyperkalaemia, Speech Disorder, Urosepsis, Asthenia, Blood Creatinine Increased
A 69-year-old male patient (weight: NA) from SPAIN with the following symptoms/conditions: pain started Enantyum treatment (dosage: 225 Mg, Tid) on Aug 31, 2011. Soon after starting Enantyum treatment, the subject experienced various side effects, including:
  • Renal Failure Acute
  • Vomiting
  • Urinary Tract Infection
  • Hyperkalaemia
  • Speech Disorder
  • Urosepsis
  • Asthenia
  • Blood Creatinine Increased
Concurrently used drugs:
  • Voltaren (75 Mg, Prn)
  • Ciprofloxacin (Unk)
  • Voltaren (150 Mg, Tid)
The patient was hospitalized. This finding indicates that some male patients could be more vulnerable to Enantyum.

Renal Failure Acute
A 83-year-old female patient from SPAIN (weight: NA) experienced symptoms, such as: pain,hypertension,hyperlipidaemia,prophylaxis and was treated with Enantyum(dosage: NA). The treatment was initiated on Apr 01, 2006. After that a consumer reported the following side effect(s):
  • Renal Failure Acute
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Enantyum efficacy:
  • Atacand
  • Simvastatin
  • Aspirin
  • Allopurinol
The patient was hospitalized.

Pneumonitis, Respiratory Failure
In this report, Enantyum was administered for the following condition: pain.A 73-year-old male consumer from UNITED STATES (weight: NA) started Enantyum treatment (dosage: NA) on Jul 12, 2010.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Pneumonitis
  • Respiratory Failure
A possible interaction with other drugs could have contributed to this reaction:
  • Vitamin B1 Tab
  • Tiotropium Bromide
  • Enoxaparin Sodium
  • Insulin
  • Fentanyl
  • Folic Acid
  • Dexamethasone
  • Vitamin B6
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 Enantyum treatment could be related to the listed above side effect(s).

Device Related Infection
This is a report of the following Enantyum side effect(s):
  • Device Related Infection
A female patient from SPAIN (weight: NA) presented with the following condition: pain,hypertension,osteoporosis,device related infection and received a treatment with Enantyum (dosage: 25 Mg, Every 8 Hrs) starting: Jan 21, 2011.The following concurrently used drugs could have generated interactions:
  • Lisinopril (20/12.5 Mg, Daily (1/d))
  • Forteo (20 Ug, Daily (1/d))
  • Rifampicina (600 Mg, Daily (1/d))
  • Opiren (30 Mg, Daily (1/d))
  • Ciprofloxacino (500 Mg, Every 12 Hours)
The patient was hospitalized.This report suggests that a Enantyum treatment could be associated with the listed above side effect(s).

Spinal Cord Compression
This Enantyum report was submitted by a female consumer from SPAIN (weight: NA). The patient was diagnosed with: NA and Enantyum was administered (dosage: 1 D/f, 2/d) starting: Sep 20, 2010. The consumer developed a set of symptoms:
  • Spinal Cord Compression
Other drugs used simultaneously:
  • Forteo (20 Ug, Daily (1/d))
  • Ferro-gradumet (1 D/f, Daily (1/d))
  • Pariet (1 D/f, Daily (1/d))
  • Nolotil (1 D/f, Every 8 Hrs)
The patient was hospitalized.Those unexpected symptoms could be linked to a Enantyum treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Transaminases Increased
This is a report of a possible correlation between Enantyum use and the following symptoms/side effect(s):
  • Transaminases Increased
which could contribute to an assessment of Enantyum risk profile.A 61-year-old male consumer from (weight: NA) was suffering from pain,thrombosis prophylaxis,diabetes mellitus and was treated with Enantyum (dosage: Prn) starting Nov 01, 2010.Other concurrent medications:
  • Pradaxa (220 Mg)
  • Insulina
  • Tramadol Hydrochloride And Acetaminophen
The patient was hospitalized.

Pseudomembranous Colitis
A 19-year-old female patient from SPAIN (weight: NA) presented with the following symptoms: NA and after a treatment with Enantyum (dosage: 25mg Three Times Per Day) experienced the following side effect(s):
  • Pseudomembranous Colitis
The treatment was started on Nov 23, 2010. Enantyum was used in combination with the following drugs:
  • Augmentin '125' (1tab Three Times Per Day)
  • Dalacin
  • Paracetamol (1g Three Times Per Day)
  • Norgestimate (1tab Per Day)
  • Tramadol Hydrochloride And Acetaminophen
  • Buscapina (10mg Three Times Per Day)
This report could alert potential Enantyum consumers.



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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    More About Enantyum

    Side Effects reported to FDA: 11

    Enantyum safety alerts: No

    Reported deaths: 3

    Reported hospitalizations: 6

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