Diabex Side Effects

Common Diabex Side Effects

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

Hepatic Steatosis (2)
Haemangioma Of Liver (2)
Convulsion (2)
Loss Of Consciousness (2)
Hepatitis (2)
Palpitations (2)
Pruritus (2)
Syncope (2)
Panic Attack (2)
Hypertension (1)
Epigastric Discomfort (1)
Coordination Abnormal (1)
Hypoaesthesia (1)
Diarrhoea (1)
Pancreatitis (1)
Paraesthesia (1)
Renal Impairment (1)
Somnolence (1)
Treatment Noncompliance (1)
Tremor (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.

Diabex Side Effects Reported to FDA

The following Diabex 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 Diabex 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.
Pruritus, Syncope, Loss Of Consciousness
This is a report of a 69-year-old male patient (weight: NA) from AUSTRALIA, suffering from the following symptoms/conditions: NA, who was treated with Diabex S.r. (dosage: 1000 Mg, start time: Oct 27, 2009), combined with:
  • Verpamil Hcl (240 Mg)
  • Crestor (10 Mg)
  • Novolog (78 U, Qd (25-28-25))
and developed a serious reaction and side effect(s). The consumer presented with:
  • Pruritus
  • Syncope
  • Loss Of Consciousness
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Diabex S.r. treatment in male patients, resulting in pruritus side effect. The patient was hospitalized.

Syncope, Loss Of Consciousness, Pruritus
This report suggests a potential Diabex S.r. Syncope, Loss Of Consciousness, Pruritus side effect(s) that can have serious consequences. A 69-year-old male patient (weight: NA) from AUSTRALIA was diagnosed with the following symptoms/conditions: NA and used Diabex S.r. (dosage: 1000 Mg) starting Oct 27, 2009. Soon after starting Diabex S.r. the patient began experiencing various side effects, including:
  • Syncope
  • Loss Of Consciousness
  • Pruritus
Drugs used concurrently:
  • Novorapid (15 U, Qd Before Evening Meal)
  • Novolog (78 U, Qd (25-28-25))
  • Verpamil Hcl (240 Mg)
  • Crestor (10 Mg)
The patient was hospitalized. Although Diabex S.r. demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as syncope, may still occur.

Epigastric Discomfort, Bile Duct Stone, Pancreatitis
This Epigastric Discomfort, Bile Duct Stone, Pancreatitis problem was reported by a consumer or non-health professional from COUNTRY NOT SPECIFIED. A 66-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus,rheumatoid arthritis. On 2002 this consumer started treatment with Diabex (dosage: NA). The following drugs were being taken at the same time:
  • Gliclazide
When commencing Diabex, the patient experienced the following unwanted symptoms/side effects:
  • Epigastric Discomfort
  • Bile Duct Stone
  • Pancreatitis
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 epigastric discomfort, may become evident only after a product is in use by the general population.

Haemangioma Of Liver, Hepatic Steatosis, Hepatitis
This is a report of a 58-year-old male patient (weight: NA) from AUSTRALIA. The patient developed the following symptoms/conditions: diabetes mellitus and was treated with Diabex Xr (dosage: NA) starting Aug 17, 2006. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Haemangioma Of Liver
  • Hepatic Steatosis
  • Hepatitis
This opens a possibility that Diabex Xr treatment could cause the above reactions, including haemangioma of liver, and some male subjects may be more susceptible.

Haemangioma Of Liver, Hepatic Steatosis, Hepatitis
A 58-year-old male patient (weight: NA) from AUSTRALIA with the following symptoms/conditions: diabetes mellitus started Diabex Xr treatment (dosage: NA) on Aug 17, 2006. Soon after starting Diabex Xr treatment, the subject experienced various side effects, including:
  • Haemangioma Of Liver
  • Hepatic Steatosis
  • Hepatitis
Concurrently used drugs: NA. This finding indicates that some male patients could be more vulnerable to Diabex Xr.

Hypertension, Palpitations, Panic Attack
A 52-year-old female patient from AUSTRALIA (weight: NA) experienced symptoms, such as: type 2 diabetes mellitus and was treated with Diabex Xr (metformin) (500 Mg)(dosage: 500 Mg; At Bedtime; Oral). The treatment was initiated on Apr 01, 2008. After that a consumer reported the following side effect(s):
  • Hypertension
  • Palpitations
  • Panic Attack
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Diabex Xr (metformin) (500 Mg) efficacy:
  • Thyroxine
  • Crestor

Blood Pressure Increased, Palpitations, Panic Attack, Treatment Noncompliance
In this report, Diabex Xr (metformin) was administered for the following condition: type 2 diabetes mellitus.A 52-year-old female consumer from AUSTRALIA (weight: NA) started Diabex Xr (metformin) treatment (dosage: 500 Mg; At Bedtime Oral, 500 Mg; Modified-release Tablet; Oral; At Bedtime) on Apr 01, 2008.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Blood Pressure Increased
  • Palpitations
  • Panic Attack
  • Treatment Noncompliance
A possible interaction with other drugs could have contributed to this reaction:
  • Levothyroxine Sodium
  • Crestor
Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Diabex Xr (metformin) treatment could be related to the listed above side effect(s).

Condition Aggravated, Convulsion
This is a report of the following Diabex (metformin Hydrochloride) side effect(s):
  • Condition Aggravated
  • Convulsion
A 30-year-old male patient from (weight: NA) presented with the following condition: NA and received a treatment with Diabex (metformin Hydrochloride) (dosage: Oral) starting: Jan 01, 2007.The following concurrently used drugs could have generated interactions:
  • Epilim
This report suggests that a Diabex (metformin Hydrochloride) treatment could be associated with the listed above side effect(s).

This Diabex (metformin Hydrochloride) report was submitted by a 30-year-old male consumer from AUSTRALIA (weight: NA). The patient was diagnosed with: NA and Diabex (metformin Hydrochloride) was administered (dosage: Oral) starting: Jan 01, 2007. The consumer developed a set of symptoms:
  • Convulsion
Other drugs used simultaneously:
  • Valproate Sodium
Those unexpected symptoms could be linked to a Diabex (metformin Hydrochloride) treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Coordination Abnormal, Diarrhoea, Hypoaesthesia, Paraesthesia, Renal Impairment, Somnolence, Tremor, Vomiting
This is a report of a possible correlation between Diabex use and the following symptoms/side effect(s):
  • Coordination Abnormal
  • Diarrhoea
  • Hypoaesthesia
  • Paraesthesia
  • Renal Impairment
  • Somnolence
  • Tremor
  • Vomiting
which could contribute to an assessment of Diabex risk profile.A 46-year-old male consumer from GERMANY (weight: NA) was suffering from metabolic disorder,gout,oedema,essential hypertension and was treated with Diabex (dosage: NA) starting Nov 11, 2005.Other concurrent medications:
  • Progout
  • Amizide
  • Atacand
  • Lasix
  • Celebrex
  • Nexium
  • Lipitor
  • Calcium Chloride
The patient was hospitalized.

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 Diabex Side Effects

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