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

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Incorrect Dose Administered, Product Adhesion Issue (7480515-2)
on May 03, 2011 Female from FRANCE , 51 years of age, was treated with Actiskenan. Directly after, patient experienced the unwanted or unexpected Actiskenan side effects: incorrect dose administered, product adhesion issue. Actiskenan dosage: N/A.
Associated medications used:
  • Duragesic-100


Muscular Weakness (7476738-9)
Patient was taking Actiskenan. Patient felt the following Actiskenan side effects: muscular weakness on May 11, 2011 from FRANCE Additional patient health information: Male , 75 years of age, weighting 143.3 lb, was diagnosed with
  • pain
  • ascites
  • constipation
and. Actiskenan dosage: N/A.
Multiple prescriptions taken:
  • Aldactone
  • Debridat (1df=3 Tablets)
  • Duragesic-100 (Transdermal Patch)
  • Yervoy (Infusion)
  • Forlax (1df=3 Sachets.)
  • Imovane (1df=1 Tablet)
Patient was hospitalized.

Bradycardia, Intentional Overdose, Pneumonia Aspiration, Coma, Renal Failure Acute (7426421-0)
Adverse event was reported on Apr 12, 2011 by a Male taking Actiskenan (Dosage: 20 Df, Single) . Location: FRANCE , 47 years of age, After Actiskenan was administered, patient encountered several Actiskenan side effects: bradycardia, intentional overdose, pneumonia aspiration, coma, renal failure acute.
Multiple concurrent drugs taken:
  • Effexor Xr (750 Mg, Single)
  • Stilnox (14 Df, Single)
  • Zyprexa (140 Mg, Single)
Patient was hospitalized.

Hypothyroidism, Pneumoperitoneum, Peritonitis (7277104-1)
on Feb 02, 2011 Female from FRANCE , 57 years of age, weighting 110.2 lb, was treated with Actiskenan. Directly after, patient experienced the unwanted or unexpected Actiskenan side effects: hypothyroidism, pneumoperitoneum, peritonitis. Actiskenan dosage: N/A.
Associated medications used:
  • Acetaminophen
  • Nexium
  • Levothyrox
  • Sutent (50 Mg, Daily, 4-week Cycles With 2-week Discontinuation)
  • Morphine Sulfate
  • Lyrica
Patient was hospitalized.


Muscle Disorder, Quadriplegia, Rash, Rhabdomyolysis, Monoplegia (7229106-9)
on Jan 11, 2011 Female from JAPAN , 51 years of age, was treated with Actiskenan. Patient felt the following Actiskenan side effects: muscle disorder, quadriplegia, rash, rhabdomyolysis, monoplegia. Actiskenan dosage: N/A.
Multiple prescriptions taken:
  • Stilnox
  • Claforan
  • Effexor
  • Morphine Sulfate
  • Xyzal
  • Tavanic
  • Seglor
  • Lysanxia
Patient was hospitalized.

Faecaloma (7014822-4)
Patient was taking Actiskenan Caps 10 Mg. After Actiskenan was administered, patient encountered several Actiskenan side effects: faecaloma on Sep 22, 2010 from FRANCE Additional patient health information: Male , 65 years of age, was diagnosed with
  • pain
  • colon cancer
and. Actiskenan Caps 10 Mg dosage: N/A.
Multiple concurrent drugs taken:
  • Paraplatin
  • Etoposide
  • Duragesic-100 (8.4 Mg/21 Cm2.durogesic (fentanyl) 50 Microgram/hour .1 Df: 1 Patch)
Patient was hospitalized.

Confusional State, Constipation, Dysuria, Extrapyramidal Disorder, Malaise, Nightmare, Orthostatic Hypotension, Psychomotor Retardation (6660564-4)
Adverse event was reported on Mar 16, 2010 by a Female taking Actiskenan Caps 10 Mg (Dosage: N/A) . Location: UNITED STATES , 82 years of age, Directly after, patient experienced the unwanted or unexpected Actiskenan side effects: confusional state, constipation, dysuria, extrapyramidal disorder, malaise, nightmare, orthostatic hypotension, psychomotor retardation.
Associated medications used:
  • Sinemet (1df=3.5(no Units Mentioned). Sinemet100mg.)
  • Duragesic-100 (For Every 3days.)
  • Ketoprofen
  • Stilnox (1tab)
  • Lexomil
  • Lamaline (1 Df = 2intakes(dose).)
  • Deroxat
  • Requip
Patient was hospitalized.

Confusional State, Constipation, Dysuria, Extrapyramidal Disorder, Malaise, Nightmare, Orthostatic Hypotension, Psychomotor Retardation (6653235-1)
on Mar 16, 2010 Female from FRANCE , 82 years of age, was treated with Actiskenan Caps 10 Mg. Patient felt the following Actiskenan side effects: confusional state, constipation, dysuria, extrapyramidal disorder, malaise, nightmare, orthostatic hypotension, psychomotor retardation. Actiskenan Caps 10 Mg dosage: N/A.
Multiple prescriptions taken:
  • Sinemet (1df=3.5(no Units Mentioned). Sinemet100mg.)
  • Duragesic-100 (For Every 3days.)
  • Ketoprofen
  • Stilnox (1tab)
  • Lexomil
  • Lamaline (1 Df = 2intakes)
  • Deroxat
  • Requip
Patient was hospitalized.

Anaemia, Condition Aggravated, Thrombocytopenia (6308635-6)
on Aug 03, 2009 Male from FRANCE , 69 years of age, was treated with Actiskenan. After Actiskenan was administered, patient encountered several Actiskenan side effects: anaemia, condition aggravated, thrombocytopenia. Actiskenan dosage: Unk.
Multiple concurrent drugs taken:
  • Forlax (Unk)
Patient was hospitalized.

Nephropathy, Renal Failure Acute, Urinary Tract Infection (5814473-0)
Patient was taking Actiskenan Caps 5 Mg. Directly after, patient experienced the unwanted or unexpected Actiskenan side effects: nephropathy, renal failure acute, urinary tract infection on Jul 15, 2008 from FRANCE Additional patient health information: Female , 83 years of age, . Actiskenan Caps 5 Mg dosage: N/A.
Associated medications used:
  • Penicillin G Potassium
  • Pravadual
  • Pyostacine
  • Tavanic
  • Lasix
  • Kenzen
  • Tardyferon
  • Ascorbic Acid
Patient was hospitalized.

Abdominal Pain, Arrhythmia, Atrioventricular Block First Degree, Back Pain, C-reactive Protein Increased, Constipation, Erysipelas, Feeling Cold, Flatulence (5719739-0)
Adverse event was reported on Apr 17, 2008 by a Female taking Actiskenan (Dosage: 5 Mg, Once/single) was diagnosed with
  • spinal compression fracture
and. Location: FRANCE , 95 years of age, Patient felt the following Actiskenan side effects: abdominal pain, arrhythmia, atrioventricular block first degree, back pain, c-reactive protein increased, constipation, erysipelas, feeling cold, flatulence. Patient was hospitalized.

Anuria, Blood Creatinine Increased, Coma, Depressed Level Of Consciousness, Intubation, Myoclonus, Nervous System Disorder, Renal Failure Acute (4646646-7)
on Mar 30, 2005 Female from , 69 years of age, was diagnosed with
  • venous ulcer pain
  • thrombosis prophylaxis
  • hypertension
and was treated with Actiskenan. After Actiskenan was administered, patient encountered several Actiskenan side effects: anuria, blood creatinine increased, coma, depressed level of consciousness, intubation, myoclonus, nervous system disorder, renal failure acute. Actiskenan dosage: 10 Mg/day.
Multiple concurrent drugs taken:
  • Lovenox (40 Mg/24 Hours)
  • Nisisco (1 Df, Qd)
  • Neurontin (800 Mg, Bid)
  • Deroxat (20 Mg, Bid)
  • Rivotril (8 Drp, Qd)
  • Stilnox (10 Mg, Qd)
  • Jamylene (50 Mg, Tid2sdo)
Patient was hospitalized.

Anuria, Blood Creatinine Increased, Coma, Depressed Level Of Consciousness, Intubation, Myoclonus, Nervous System Disorder, Renal Failure Acute (4626202-7)
on Mar 30, 2005 Female from , 69 years of age, was diagnosed with
  • venous ulcer pain
  • thrombosis prophylaxis
  • hypertension
and was treated with Actiskenan. Directly after, patient experienced the unwanted or unexpected Actiskenan side effects: anuria, blood creatinine increased, coma, depressed level of consciousness, intubation, myoclonus, nervous system disorder, renal failure acute. Actiskenan dosage: 10 Mg/day.
Associated medications used:
  • Lovenox (40 Mg/24 Hours)
  • Nisisco (1 Df, Qd)
  • Neurontin (800 Mg, Bid)
  • Deroxat (20 Mg, Bid)
  • Rivotril (8 Drp, Qd)
  • Zolpidem Tartrate
  • Jamylene (50 Mg, Tid2sdo)
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.

Actiskenan Information

More About Actiskenan

Side Effects reported to FDA: 13. View Actiskenan Adverse Reports

Actiskenan safety alerts: No

Reported deaths: 1

Reported hospitalizations: 8

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