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Alepsal Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Aplastic Anaemia, Condition Aggravated (8037791-7)
on Jan 02, 2012 Male from FRANCE , 82 years of age, was diagnosed with
  • epilepsy
and was treated with Alepsal. Directly after, patient experienced the unwanted or unexpected Alepsal side effects: aplastic anaemia, condition aggravated. Alepsal dosage: N/A.
Associated medications used:
  • Atacand
  • Bisoprolol Fumarate
  • Nitroderm
  • Nexium
  • Aspirin
  • Ezetimibe (10/40 Mg)
  • Depakene
  • Plavix
Patient was hospitalized.

Cushing's Syndrome, Skin Atrophy, Weight Increased, Arthralgia, Cardiac Failure, Movement Disorder, Erythrosis, Fluid Retention, Oedema (7830822-6)
Patient was taking Alepsal. Patient felt the following Alepsal side effects: cushing's syndrome, skin atrophy, weight increased, arthralgia, cardiac failure, movement disorder, erythrosis, fluid retention, oedema on Oct 13, 2011 from FRANCE Additional patient health information: Male , weighting 242.5 lb, . Alepsal dosage: 100mg At Night.
Multiple prescriptions taken:
  • 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)
Patient was hospitalized.

Infertility Male, Semen Analysis Abnormal, Varicocele, Spermatozoa Abnormal, Sperm Concentration Decreased (7629209-0)
Adverse event was reported on Jul 11, 2011 by a Male taking Alepsal (Dosage: Unk Ukn, Qd) . Location: FRANCE , 31 years of age, After Alepsal was administered, patient encountered several Alepsal side effects: infertility male, semen analysis abnormal, varicocele, spermatozoa abnormal, sperm concentration decreased.
Multiple concurrent drugs taken:
  • Ventolin (Occasionally)
  • Tegretol (1 Tsp (one Spoon ), Bid)


Blood Immunoglobulin E Increased, Cholestasis, Eosinophilia, Leukocytosis, Normochromic Normocytic Anaemia, Photosensitivity Reaction (5248038-9)
on Feb 15, 2007 Male from FRANCE , 83 years of age, was diagnosed with
  • epilepsy
  • hypertension
and was treated with Alepsal. Directly after, patient experienced the unwanted or unexpected Alepsal side effects: blood immunoglobulin e increased, cholestasis, eosinophilia, leukocytosis, normochromic normocytic anaemia, photosensitivity reaction. Alepsal dosage: N/A.
Associated medications used:
  • Isobar
  • Plavix
Patient was hospitalized.


Bacteria Urine Identified, Bladder Catheterisation, Pulmonary Embolism, Pyrexia (5117261-6)
on Aug 28, 2006 Female from FRANCE , 67 years of age, was treated with Alepsal. Patient felt the following Alepsal side effects: bacteria urine identified, bladder catheterisation, pulmonary embolism, pyrexia. Alepsal dosage: 2 Tablets Daily.
Multiple prescriptions taken:
  • Amlor (5 Mg, Qd)
  • Lamictal (100 Mg, Qd)
  • Tegretol (800 Mg, Daily)
Patient was hospitalized.

Colitis, Dehydration, Diarrhoea, Hypokalaemia, Intestinal Villi Atrophy, Malabsorption, Pancreatic Insufficiency, Renal Failure, Vitamin K Deficiency (5111625-2)
Patient was taking Alepsal. After Alepsal was administered, patient encountered several Alepsal side effects: colitis, dehydration, diarrhoea, hypokalaemia, intestinal villi atrophy, malabsorption, pancreatic insufficiency, renal failure, vitamin k deficiency on Sep 18, 2006 from FRANCE Additional patient health information: Male , 67 years of age, . Alepsal dosage: 1 Df, Bid.
Multiple concurrent drugs taken:
  • Zyloric
  • Tegretol (400 Mg, Q48h)
Patient was hospitalized.

Bladder Catheterisation, Pulmonary Embolism, Pyrexia, Urine Analysis Abnormal (5106249-7)
Adverse event was reported on Aug 28, 2006 by a Female taking Alepsal (Dosage: 2 Tablets Daily) . Location: FRANCE , 67 years of age, Directly after, patient experienced the unwanted or unexpected Alepsal side effects: bladder catheterisation, pulmonary embolism, pyrexia, urine analysis abnormal.
Associated medications used:
  • Amlor (5 Mg, Qd)
  • Lamictal (100 Mg, Qd)
  • Tegretol (800 Mg, Daily)
Patient was hospitalized.

Bladder Catheterisation, Cerebral Haemorrhage, Hemiplegia, Infection, Pulmonary Embolism, Pyrexia, Thrombosis, Urine Analysis Abnormal (5098647-5)
on Aug 28, 2006 Female from FRANCE , 67 years of age, was treated with Alepsal. Patient felt the following Alepsal side effects: bladder catheterisation, cerebral haemorrhage, hemiplegia, infection, pulmonary embolism, pyrexia, thrombosis, urine analysis abnormal. Alepsal dosage: 2 Tablets Daily.
Multiple prescriptions taken:
  • Amlodipine Besylate (5 Mg, Qd)
  • Lamictal (100 Mg, Qd)
  • Tegretol (800 Mg, Daily)
Patient was hospitalized.

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

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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