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Alepsal Side Effects

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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.

Alepsal Side Effects Reported to FDA



Alepsal Side Effect Report#8037791-7
Aplastic Anaemia, Condition Aggravated
This is a report of a 82-year-old male patient (weight: NA) from France, suffering from the following health 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): Aplastic Anaemia, Condition Aggravated 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.
Alepsal Side Effect Report#7830822-6
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 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. 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, OedemaAdditional 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.
Alepsal Side Effect Report#7629209-0
Infertility Male, Semen Analysis Abnormal, Varicocele, Spermatozoa Abnormal, Sperm Concentration Decreased
This Infertility Male 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 using Alepsal, the patient experienced the following unwanted symptoms/side effects: Infertility Male, Semen Analysis Abnormal, Varicocele, Spermatozoa Abnormal, Sperm Concentration DecreasedAlthough 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.
Alepsal Side Effect Report#5248038-9
Blood Immunoglobulin E Increased, Cholestasis, Eosinophilia, Leukocytosis, Normochromic Normocytic Anaemia, Photosensitivity Reaction
This Blood Immunoglobulin E Increased side effect was reported by a health professional from France. A 83-year-old male patient (weight:NA) experienced the following symptoms/conditions: epilepsy,hypertension.The patient was prescribed Alepsal (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Isobar
  • Plavix
.After starting to take Alepsal the consumer reported adverse symptoms, such as: Blood Immunoglobulin E Increased, Cholestasis, Eosinophilia, Leukocytosis, Normochromic Normocytic Anaemia, Photosensitivity ReactionThese side effects may potentially be related to Alepsal. The patient was hospitalized.
Alepsal Side Effect Report#5117261-6
Bacteria Urine Identified, Bladder Catheterisation, Pulmonary Embolism, Pyrexia
This is a report of a 67-year-old female patient (weight: NA) from France, suffering from the following health symptoms/conditions: NA, who was treated with Alepsal (dosage: 2 Tablets Daily, start time:
Jun 23, 2006), combined with:
  • Amlor (5 Mg, Qd)
  • Lamictal (100 Mg, Qd)
  • Tegretol (800 Mg, Daily)
and developed a serious reaction and side effect(s): Bacteria Urine Identified, Bladder Catheterisation, Pulmonary Embolism, Pyrexia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Alepsal treatment in female patients, resulting in Bacteria Urine Identified side effect. The patient was hospitalized.
Alepsal Side Effect Report#5111625-2
Colitis, Dehydration, Diarrhoea, Hypokalaemia, Intestinal Villi Atrophy, Malabsorption, Pancreatic Insufficiency, Renal Failure, Vitamin K Deficiency
This report suggests a potential Alepsal Colitis side effect(s) that can have serious consequences. A 67-year-old male patient (weight: NA) from France was diagnosed with the following symptoms/conditions: NA and used Alepsal (dosage: 1 Df, Bid) starting NS. After starting Alepsal the patient began experiencing various side effects, including: Colitis, Dehydration, Diarrhoea, Hypokalaemia, Intestinal Villi Atrophy, Malabsorption, Pancreatic Insufficiency, Renal Failure, Vitamin K DeficiencyAdditional drugs used concurrently:
  • Zyloric
  • Tegretol (400 Mg, Q48h)
The patient was hospitalized. Although Alepsal demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Colitis, may still occur.
Alepsal Side Effect Report#5106249-7
Bladder Catheterisation, Pulmonary Embolism, Pyrexia, Urine Analysis Abnormal
This Bladder Catheterisation problem was reported by a consumer or non-health professional from France. A 67-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jun 23, 2006 this consumer started treatment with Alepsal (dosage: 2 Tablets Daily). The following drugs were being taken at the same time:
  • Amlor (5 Mg, Qd)
  • Lamictal (100 Mg, Qd)
  • Tegretol (800 Mg, Daily)
When using Alepsal, the patient experienced the following unwanted symptoms/side effects: Bladder Catheterisation, Pulmonary Embolism, Pyrexia, Urine Analysis AbnormalThe 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 Bladder Catheterisation, may become evident only after a product is in use by the general population.
Alepsal Side Effect Report#5098647-5
Bladder Catheterisation, Cerebral Haemorrhage, Hemiplegia, Infection, Pulmonary Embolism, Pyrexia, Thrombosis, Urine Analysis Abnormal
This Bladder Catheterisation side effect was reported by a consumer or non-health professional from France. A 67-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Alepsal (drug dosage: 2 Tablets Daily), which was initiated on
Jun 13, 2006. Concurrently used drugs:
  • Amlodipine Besylate (5 Mg, Qd)
  • Lamictal (100 Mg, Qd)
  • Tegretol (800 Mg, Daily)
.After starting to take Alepsal the consumer reported adverse symptoms, such as: Bladder Catheterisation, Cerebral Haemorrhage, Hemiplegia, Infection, Pulmonary Embolism, Pyrexia, Thrombosis, Urine Analysis AbnormalThese side effects may potentially be related to Alepsal. The patient was hospitalized.



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.

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.

    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.

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    More About Alepsal

    Side Effects reported to FDA: 8

    Alepsal safety alerts: No

    Reported hospitalizations: 7

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