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Alepsal Side Effects

Common Alepsal Side Effects


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

Pyrexia (3)
Pulmonary Embolism (3)
Bladder Catheterisation (3)
Urine Analysis Abnormal (2)
Sperm Concentration Decreased (1)
Skin Atrophy (1)
Semen Analysis Abnormal (1)
Varicocele (1)
Vitamin K Deficiency (1)
Renal Failure (1)
Thrombosis (1)
Spermatozoa Abnormal (1)
Leukocytosis (1)
Oedema (1)
Pancreatic Insufficiency (1)
Normochromic Normocytic Anaemia (1)
Movement Disorder (1)
Intestinal Villi Atrophy (1)
Malabsorption (1)
Photosensitivity Reaction (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.

Alepsal Side Effects Reported to FDA

The following Alepsal 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 Alepsal 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.
Aplastic Anaemia, Condition Aggravated
This is a report of a 82-year-old male patient (weight: NA) from FRANCE, suffering from the following symptoms/conditions: epilepsy, who was treated with Alepsal (dosage: NA, start time: Sep 01, 2011), combined with:
  • Atacand
  • Bisoprolol Fumarate
  • Nitroderm
  • Nexium
  • Aspirin
  • Ezetimibe (10/40 Mg)
  • Depakene
  • Plavix
and developed a serious reaction and side effect(s). The consumer presented with:
  • Aplastic Anaemia
  • Condition Aggravated
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Alepsal treatment in male patients, resulting in aplastic anaemia side effect. The patient was hospitalized.

Cushing's Syndrome, Skin Atrophy, Weight Increased, Arthralgia, Cardiac Failure, Movement Disorder, Erythrosis, Fluid Retention, Oedema
This report suggests a potential Alepsal Cushing's Syndrome, Skin Atrophy, Weight Increased, Arthralgia, Cardiac Failure, Movement Disorder, Erythrosis, Fluid Retention, Oedema side effect(s) that can have serious consequences. A male patient (weight: NA) from FRANCE was diagnosed with the following symptoms/conditions: NA and used Alepsal (dosage: 100mg At Night) starting Jan 01, 2010. Soon after starting Alepsal the patient began experiencing various side effects, including:
  • Cushing's Syndrome
  • Skin Atrophy
  • Weight Increased
  • Arthralgia
  • Cardiac Failure
  • Movement Disorder
  • Erythrosis
  • Fluid Retention
  • Oedema
Drugs used concurrently:
  • Levothyroxine Sodium (25mcg In The Morning)
  • Tranxene (5mg Twice Per Day)
  • Aldactone (50mg In The Morning)
  • Alfuzosin Hcl (10mg At Night)
  • Clobetasol Propionate
  • Lasix (40mg Twice Per Day)
  • Nexium (40mg At Night)
  • Amiodarone Hcl (200mg See Dosage Text)
The patient was hospitalized. Although Alepsal demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as cushing's syndrome, may still occur.

Infertility Male, Semen Analysis Abnormal, Varicocele, Spermatozoa Abnormal, Sperm Concentration Decreased
This Infertility Male, Semen Analysis Abnormal, Varicocele, Spermatozoa Abnormal, Sperm Concentration Decreased problem was reported by a consumer or non-health professional from FRANCE. A 31-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Alepsal (dosage: Unk Ukn, Qd). The following drugs were being taken at the same time:
  • Ventolin (Occasionally)
  • Tegretol (1 Tsp (one Spoon ), Bid)
When commencing Alepsal, the patient experienced the following unwanted symptoms/side effects:
  • Infertility Male
  • Semen Analysis Abnormal
  • Varicocele
  • Spermatozoa Abnormal
  • Sperm Concentration Decreased
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as infertility male, may become evident only after a product is in use by the general population.

Blood Immunoglobulin E Increased, Cholestasis, Eosinophilia, Leukocytosis, Normochromic Normocytic Anaemia, Photosensitivity Reaction
This is a report of a 83-year-old male patient (weight: NA) from FRANCE. The patient developed the following symptoms/conditions: epilepsy,hypertension and was treated with Alepsal (dosage: NA) starting NS. Concurrently used drugs:
  • Isobar
  • Plavix
Soon after that, the consumer experienced the following side effects:
  • Blood Immunoglobulin E Increased
  • Cholestasis
  • Eosinophilia
  • Leukocytosis
  • Normochromic Normocytic Anaemia
  • Photosensitivity Reaction
The patient was hospitalized. This opens a possibility that Alepsal treatment could cause the above reactions, including blood immunoglobulin e increased, and some male subjects may be more susceptible.


Bacteria Urine Identified, Bladder Catheterisation, Pulmonary Embolism, Pyrexia
A 67-year-old female patient (weight: NA) from FRANCE with the following symptoms/conditions: NA started Alepsal treatment (dosage: 2 Tablets Daily) on Jun 23, 2006. Soon after starting Alepsal treatment, the subject experienced various side effects, including:
  • Bacteria Urine Identified
  • Bladder Catheterisation
  • Pulmonary Embolism
  • Pyrexia
Concurrently used drugs:
  • Amlor (5 Mg, Qd)
  • Lamictal (100 Mg, Qd)
  • Tegretol (800 Mg, Daily)
The patient was hospitalized. This finding indicates that some female patients could be more vulnerable to Alepsal.

Colitis, Dehydration, Diarrhoea, Hypokalaemia, Intestinal Villi Atrophy, Malabsorption, Pancreatic Insufficiency, Renal Failure, Vitamin K Deficiency
A 67-year-old male patient from FRANCE (weight: NA) experienced symptoms, such as: NA and was treated with Alepsal(dosage: 1 Df, Bid). The treatment was initiated on NS. After that a consumer reported the following side effect(s):
  • Colitis
  • Dehydration
  • Diarrhoea
  • Hypokalaemia
  • Intestinal Villi Atrophy
  • Malabsorption
  • Pancreatic Insufficiency
  • Renal Failure
  • Vitamin K Deficiency
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Alepsal efficacy:
  • Zyloric
  • Tegretol (400 Mg, Q48h)
The patient was hospitalized.

Bladder Catheterisation, Pulmonary Embolism, Pyrexia, Urine Analysis Abnormal
In this report, Alepsal was administered for the following condition: NA.A 67-year-old female consumer from FRANCE (weight: NA) started Alepsal treatment (dosage: 2 Tablets Daily) on Jun 23, 2006.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Bladder Catheterisation
  • Pulmonary Embolism
  • Pyrexia
  • Urine Analysis Abnormal
A possible interaction with other drugs could have contributed to this reaction:
  • Amlor (5 Mg, Qd)
  • Lamictal (100 Mg, Qd)
  • Tegretol (800 Mg, Daily)
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 Alepsal treatment could be related to the listed above side effect(s).

Bladder Catheterisation, Cerebral Haemorrhage, Hemiplegia, Infection, Pulmonary Embolism, Pyrexia, Thrombosis, Urine Analysis Abnormal
This is a report of the following Alepsal side effect(s):
  • Bladder Catheterisation
  • Cerebral Haemorrhage
  • Hemiplegia
  • Infection
  • Pulmonary Embolism
  • Pyrexia
  • Thrombosis
  • Urine Analysis Abnormal
A 67-year-old female patient from FRANCE (weight: NA) presented with the following condition: NA and received a treatment with Alepsal (dosage: 2 Tablets Daily) starting: Jun 13, 2006.The following concurrently used drugs could have generated interactions:
  • Amlodipine Besylate (5 Mg, Qd)
  • Lamictal (100 Mg, Qd)
  • Tegretol (800 Mg, Daily)
The patient was hospitalized.This report suggests that a Alepsal treatment could be associated with the listed above side effect(s).



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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    Alepsal Safety Alerts, Active Ingredients, Usage Information

    More About Alepsal

    Side Effects reported to FDA: 8

    Alepsal safety alerts: No

    Reported hospitalizations: 7

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