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Actiskenan Side Effects

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Common Actiskenan Side Effects


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

Renal Failure Acute (5)
Coma (3)
Constipation (3)
Myoclonus (2)
Nervous System Disorder (2)
Malaise (2)
Extrapyramidal Disorder (2)
Anuria (2)
Intubation (2)
Orthostatic Hypotension (2)
Nightmare (2)
Psychomotor Retardation (2)
Dysuria (2)
Confusional State (2)
Blood Creatinine Increased (2)
Depressed Level Of Consciousness (2)
Muscular Weakness (1)
Nephropathy (1)
Bradycardia (1)
Pneumonia Aspiration (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.

Actiskenan Side Effects Reported to FDA



Actiskenan Side Effect Report#9533849
Renal Failure Acute, Vomiting
This is a report of a 88-year-old female patient (weight: NA) from FR, suffering from the following health symptoms/conditions: NA, who was treated with Actiskenan Caps 5 Mg (dosage: 1df:6/d, start time: 201306), combined with:
  • Paracetamol
  • Glucophage Tabs 500 Mg
  • Mono-tildiem Lp
  • Bipreterax (1df:4mg/1.25mg)
  • Thalidomide
  • Melphalan (10mg For 4 Days Then 40 Mg Every 6 Weeks)
  • Prednisone
  • Previscan (Str Previscan 20 Mg)
and developed a serious reaction and side effect(s): Renal Failure Acute, Vomiting after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Actiskenan Caps 5 Mg treatment in female patients, resulting in Renal Failure Acute side effect. The patient was hospitalized.
Actiskenan Side Effect Report#7480515-2
Incorrect Dose Administered, Product Adhesion Issue
This report suggests a potential Actiskenan Incorrect Dose Administered side effect(s) that can have serious consequences. A 51-year-old female patient (weight: NA) from France was diagnosed with the following symptoms/conditions: NA and used Actiskenan (dosage: NA) starting NS. After starting Actiskenan the patient began experiencing various side effects, including: Incorrect Dose Administered, Product Adhesion IssueAdditional drugs used concurrently:
  • Duragesic-100
Although Actiskenan demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Incorrect Dose Administered, may still occur.
Actiskenan Side Effect Report#7476738-9
Muscular Weakness
This Muscular Weakness problem was reported by a health professional from France. A 75-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: pain,ascites,constipation. On
Apr 29, 2011 this consumer started treatment with Actiskenan (dosage: NA). The following drugs were being taken at the same time:
  • Aldactone
  • Debridat (1df=3 Tablets)
  • Duragesic-100 (Transdermal Patch)
  • Yervoy (Infusion)
  • Forlax (1df=3 Sachets.)
  • Imovane (1df=1 Tablet)
When using Actiskenan, the patient experienced the following unwanted symptoms/side effects: Muscular WeaknessThe 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 Muscular Weakness, may become evident only after a product is in use by the general population.
Actiskenan Side Effect Report#7426421-0
Bradycardia, Intentional Overdose, Pneumonia Aspiration, Coma, Renal Failure Acute
This Bradycardia side effect was reported by a health professional from France. A 47-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Actiskenan (drug dosage: 20 Df, Single), which was initiated on
Jan 08, 2011. Concurrently used drugs:
  • Effexor Xr (750 Mg, Single)
  • Stilnox (14 Df, Single)
  • Zyprexa (140 Mg, Single)
.After starting to take Actiskenan the consumer reported adverse symptoms, such as: Bradycardia, Intentional Overdose, Pneumonia Aspiration, Coma, Renal Failure AcuteThese side effects may potentially be related to Actiskenan. The patient was hospitalized.
Actiskenan Side Effect Report#7277104-1
Hypothyroidism, Pneumoperitoneum, Peritonitis
This is a report of a 57-year-old female patient (weight: NA) from France, suffering from the following health symptoms/conditions: NA, who was treated with Actiskenan (dosage: NA, start time:
Apr 01, 2010), combined with:
  • Acetaminophen
  • Nexium
  • Levothyrox
  • Sutent (50 Mg, Daily, 4-week Cycles With 2-week Discontinuation)
  • Morphine Sulfate
  • Lyrica
and developed a serious reaction and side effect(s): Hypothyroidism, Pneumoperitoneum, Peritonitis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Actiskenan treatment in female patients, resulting in Hypothyroidism side effect. The patient was hospitalized.
Actiskenan Side Effect Report#7229106-9
Muscle Disorder, Quadriplegia, Rash, Rhabdomyolysis, Monoplegia
This report suggests a potential Actiskenan Muscle Disorder side effect(s) that can have serious consequences. A 51-year-old female patient (weight: NA) from Japan was diagnosed with the following symptoms/conditions: NA and used Actiskenan (dosage: NA) starting NS. After starting Actiskenan the patient began experiencing various side effects, including: Muscle Disorder, Quadriplegia, Rash, Rhabdomyolysis, MonoplegiaAdditional drugs used concurrently:
  • Stilnox
  • Claforan
  • Effexor
  • Morphine Sulfate
  • Xyzal
  • Tavanic
  • Seglor
  • Lysanxia
The patient was hospitalized. Although Actiskenan demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Muscle Disorder, may still occur.
Actiskenan Side Effect Report#7014822-4
Faecaloma
This Faecaloma problem was reported by a physician from France. A 65-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: pain,colon cancer. On
May 01, 2010 this consumer started treatment with Actiskenan Caps 10 Mg (dosage: NA). The following drugs were being taken at the same time:
  • Paraplatin
  • Etoposide
  • Duragesic-100 (8.4 Mg/21 Cm2.durogesic (fentanyl) 50 Microgram/hour .1 Df: 1 Patch)
When using Actiskenan Caps 10 Mg, the patient experienced the following unwanted symptoms/side effects: FaecalomaThe 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 Faecaloma, may become evident only after a product is in use by the general population.
Actiskenan Side Effect Report#6660564-4
Confusional State, Constipation, Dysuria, Extrapyramidal Disorder, Malaise, Nightmare, Orthostatic Hypotension, Psychomotor Retardation
This Confusional State side effect was reported by a consumer or non-health professional from United States. A 82-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Actiskenan Caps 10 Mg (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Sinemet (1df=3.5(no Units Mentioned). Sinemet100mg.)
  • Duragesic-100 (For Every 3days.)
  • Ketoprofen
  • Stilnox (1tab)
  • Lexomil
  • Lamaline (1 Df = 2intakes(dose).)
  • Deroxat
  • Requip
.After starting to take Actiskenan Caps 10 Mg the consumer reported adverse symptoms, such as: Confusional State, Constipation, Dysuria, Extrapyramidal Disorder, Malaise, Nightmare, Orthostatic Hypotension, Psychomotor RetardationThese side effects may potentially be related to Actiskenan Caps 10 Mg. The patient was hospitalized.
Actiskenan Side Effect Report#6653235-1
Confusional State, Constipation, Dysuria, Extrapyramidal Disorder, Malaise, Nightmare, Orthostatic Hypotension, Psychomotor Retardation
This is a report of a 82-year-old female patient (weight: NA) from France, suffering from the following health symptoms/conditions: NA, who was treated with Actiskenan Caps 10 Mg (dosage: NA, start time: NS), combined with:
  • Sinemet (1df=3.5(no Units Mentioned). Sinemet100mg.)
  • Duragesic-100 (For Every 3days.)
  • Ketoprofen
  • Stilnox (1tab)
  • Lexomil
  • Lamaline (1 Df = 2intakes)
  • Deroxat
  • Requip
and developed a serious reaction and side effect(s): Confusional State, Constipation, Dysuria, Extrapyramidal Disorder, Malaise, Nightmare, Orthostatic Hypotension, Psychomotor Retardation after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Actiskenan Caps 10 Mg treatment in female patients, resulting in Confusional State side effect. The patient was hospitalized.
Actiskenan Side Effect Report#6308635-6
Anaemia, Condition Aggravated, Thrombocytopenia
This report suggests a potential Actiskenan Anaemia side effect(s) that can have serious consequences. A 69-year-old male patient (weight: NA) from France was diagnosed with the following symptoms/conditions: NA and used Actiskenan (dosage: Unk) starting
Apr 01, 2009. After starting Actiskenan the patient began experiencing various side effects, including: Anaemia, Condition Aggravated, ThrombocytopeniaAdditional drugs used concurrently:
  • Forlax (Unk)
The patient was hospitalized. Although Actiskenan demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Anaemia, may still occur.
Actiskenan Side Effect Report#5814473-0
Nephropathy, Renal Failure Acute, Urinary Tract Infection
This Nephropathy problem was reported by a physician from France. A 83-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
May 01, 2008 this consumer started treatment with Actiskenan Caps 5 Mg (dosage: NA). The following drugs were being taken at the same time:
  • Penicillin G Potassium
  • Pravadual
  • Pyostacine
  • Tavanic
  • Lasix
  • Kenzen
  • Tardyferon
  • Ascorbic Acid
When using Actiskenan Caps 5 Mg, the patient experienced the following unwanted symptoms/side effects: Nephropathy, Renal Failure Acute, Urinary Tract InfectionThe 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 Nephropathy, may become evident only after a product is in use by the general population.
Actiskenan Side Effect Report#5719739-0
Abdominal Pain, Arrhythmia, Atrioventricular Block First Degree, Back Pain, C-reactive Protein Increased, Constipation, Erysipelas, Feeling Cold, Flatulence
This Abdominal Pain side effect was reported by a consumer or non-health professional from France. A 95-year-old female patient (weight:NA) experienced the following symptoms/conditions: spinal compression fracture.The patient was prescribed Actiskenan (drug dosage: 5 Mg, Once/single), which was initiated on
Mar 24, 2007. Concurrently used drugs: NA..After starting to take Actiskenan the consumer reported adverse symptoms, such as: Abdominal Pain, Arrhythmia, Atrioventricular Block First Degree, Back Pain, C-reactive Protein Increased, Constipation, Erysipelas, Feeling Cold, FlatulenceThese side effects may potentially be related to Actiskenan. The patient was hospitalized.
Actiskenan Side Effect Report#4646646-7
Anuria, Blood Creatinine Increased, Coma, Depressed Level Of Consciousness, Intubation, Myoclonus, Nervous System Disorder, Renal Failure Acute
This is a report of a 69-year-old female patient (weight: NA) from , suffering from the following health symptoms/conditions: venous ulcer pain,thrombosis prophylaxis,hypertension, who was treated with Actiskenan (dosage: 10 Mg/day, start time:
Jan 01, 2005), combined with:
  • 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)
and developed a serious reaction and side effect(s): Anuria, Blood Creatinine Increased, Coma, Depressed Level Of Consciousness, Intubation, Myoclonus, Nervous System Disorder, Renal Failure Acute after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Actiskenan treatment in female patients, resulting in Anuria side effect. The patient was hospitalized.
Actiskenan Side Effect Report#4626202-7
Anuria, Blood Creatinine Increased, Coma, Depressed Level Of Consciousness, Intubation, Myoclonus, Nervous System Disorder, Renal Failure Acute
This report suggests a potential Actiskenan Anuria side effect(s) that can have serious consequences. A 69-year-old female patient (weight: NA) from was diagnosed with the following symptoms/conditions: venous ulcer pain,thrombosis prophylaxis,hypertension and used Actiskenan (dosage: 10 Mg/day) starting
Jan 01, 2004. After starting Actiskenan the patient began experiencing various side effects, including: Anuria, Blood Creatinine Increased, Coma, Depressed Level Of Consciousness, Intubation, Myoclonus, Nervous System Disorder, Renal Failure AcuteAdditional drugs used concurrently:
  • 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)
The patient was hospitalized. Although Actiskenan demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Anuria, may still occur.


The appearance of Actiskenan 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.

    Actiskenan 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 Actiskenan

    Side Effects reported to FDA: 14

    Actiskenan safety alerts: No

    Reported deaths: 1

    Reported hospitalizations: 8

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