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Spasfon Side Effects

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Common Spasfon Side Effects


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

Abortion Spontaneous (2)
Disorientation (2)
Renal Failure Acute (2)
Confusional State (2)
Pregnancy With Contraceptive Device (1)
Pregnancy On Contraceptive (1)
Vulvovaginal Discomfort (1)
Stillbirth (1)
Shoulder Dystocia (1)
Peripheral Nerve Palsy (1)
Superinfection (1)
Transaminases Increased (1)
Loss Of Consciousness (1)
Neoplasm Malignant (1)
Oedema Peripheral (1)
Maternal Exposure During Pregnancy (1)
Malaise (1)
Local Swelling (1)
Lung Disorder (1)
Large For Dates Baby (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.

Spasfon Side Effects Reported to FDA



Spasfon Side Effect Report#8178033-1
Renal Colic
This is a report of a 22-year-old female patient (weight: NA) from France, suffering from the following health symptoms/conditions: abdominal pain,crohn's disease, who was treated with Spasfon (dosage: NA, start time:
Jun 01, 2010), combined with:
  • Humira
  • Humira
  • Acetaminophen
  • Humira
  • Claritin
  • Clobetasol Propionate (1 Application)
and developed a serious reaction and side effect(s): Renal Colic after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Spasfon treatment in female patients, resulting in Renal Colic side effect. The patient was hospitalized.
Spasfon Side Effect Report#8068933-5
Back Pain, Malaise, Loss Of Consciousness
This report suggests a potential Spasfon (phloroglucinol, Trimethylphloroglucinol) Back Pain side effect(s) that can have serious consequences. A 37-year-old female patient (weight: NA) from Italy was diagnosed with the following symptoms/conditions: pain,urinary tract infection and used Spasfon (phloroglucinol, Trimethylphloroglucinol) (dosage: 2 Dosage Form (2 Dosage Forms,1 In 1 D),oral) starting
Jan 05, 2012. After starting Spasfon (phloroglucinol, Trimethylphloroglucinol) the patient began experiencing various side effects, including: Back Pain, Malaise, Loss Of ConsciousnessAdditional drugs used concurrently:
  • Fosfomycin (fofomycin Trometamol) (3 Gram, Granulate) ((3 Gm,once),oral)
Although Spasfon (phloroglucinol, Trimethylphloroglucinol) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Back Pain, may still occur.
Spasfon Side Effect Report#7953512-8
Lung Disorder
This Lung Disorder problem was reported by a physician from France. A 68-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: prophylaxis,hypertension,glioblastoma,muscle spasticity,insomnia,brain oedema. On
Nov 01, 2010 this consumer started treatment with Spasfon (dosage: Unk). The following drugs were being taken at the same time:
  • Valsartan (Unk)
  • Temozolomide (120 Mg, Unk)
  • Lioresal (Unk)
  • Lexomil (Unk)
  • Medrol (Unk)
  • Bevacizumab (580 Mg, Unk)
  • Irinotecan Hcl (190 Mg, Unk)
  • Motilium (Unk)
When using Spasfon, the patient experienced the following unwanted symptoms/side effects: Lung DisorderThe 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 Lung Disorder, may become evident only after a product is in use by the general population.
Spasfon Side Effect Report#7815559-1
Eyelid Oedema, Eyelids Pruritus, Pruritus, Local Swelling
This Eyelid Oedema side effect was reported by a physician from France. A female patient (weight:NA) experienced the following symptoms/conditions: crohn's disease.The patient was prescribed Spasfon (drug dosage: On Request If Pain), which was initiated on
Jan 01, 2007. Concurrently used drugs:
  • Humira (Induction Dose With 160mg)
  • Xanax (If Needed)
  • Pentasa (2 In 1 Day, 4 Gram, 2 Gigabecquerels)
  • Humira
  • Diane
.After starting to take Spasfon the consumer reported adverse symptoms, such as: Eyelid Oedema, Eyelids Pruritus, Pruritus, Local SwellingThese side effects may potentially be related to Spasfon.
Spasfon Side Effect Report#7812422-7
Vulvovaginal Discomfort, Device Dislocation, Abortion Spontaneous, Pregnancy With Contraceptive Device
This is a report of a 29-year-old female patient (weight: NA) from France, suffering from the following health symptoms/conditions: NA, who was treated with Spasfon (dosage: NA, start time:
Dec 03, 2010), combined with:
  • Nuvaring
  • Ketoprofen
and developed a serious reaction and side effect(s): Vulvovaginal Discomfort, Device Dislocation, Abortion Spontaneous, Pregnancy With Contraceptive Device after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Spasfon treatment in female patients, resulting in Vulvovaginal Discomfort side effect.
Spasfon Side Effect Report#7809878-2
Cognitive Disorder, Aphasia, Disorientation, Incoherent, Confusional State, Abnormal Behaviour
This report suggests a potential Spasfon Cognitive Disorder side effect(s) that can have serious consequences. A 79-year-old female patient (weight: NA) from France was diagnosed with the following symptoms/conditions: NA and used Spasfon (dosage: 2 Df, 3x/day) starting
Feb 01, 2011. After starting Spasfon the patient began experiencing various side effects, including: Cognitive Disorder, Aphasia, Disorientation, Incoherent, Confusional State, Abnormal BehaviourAdditional drugs used concurrently:
  • Paracetamol (1 G, 3x/day)
  • Lyrica (Unk)
  • Lyrica
  • Levothyroxine Sodium (75 Ug, 1x/day)
  • Zolpidem (0.5 Df, 1x/day)
The patient was hospitalized. Although Spasfon demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cognitive Disorder, may still occur.
Spasfon Side Effect Report#7802609-1
Abortion Spontaneous, Pregnancy On Contraceptive, Maternal Exposure During Pregnancy
This Abortion Spontaneous problem was reported by a physician from France. A 29-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Spasfon (dosage: NA). The following drugs were being taken at the same time:
  • Ketoprofen
  • Nuvaring
When using Spasfon, the patient experienced the following unwanted symptoms/side effects: Abortion Spontaneous, Pregnancy On Contraceptive, Maternal Exposure During PregnancyAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Abortion Spontaneous, may become evident only after a product is in use by the general population.
Spasfon Side Effect Report#7717739-2
Stillbirth
This Stillbirth side effect was reported by a pharmacist from France. A male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Spasfon (drug dosage: NA), which was initiated on
Mar 26, 2011. Concurrently used drugs:
  • Omeprazole
  • Triphasil-21
.After starting to take Spasfon the consumer reported adverse symptoms, such as: StillbirthThese side effects may potentially be related to Spasfon.
Spasfon Side Effect Report#7655671-3
Jaundice Cholestatic
This is a report of a 77-year-old male patient (weight: NA) from France, suffering from the following health symptoms/conditions: pain,atrial fibrillation,pulmonary arterial hypertension, who was treated with Spasfon (dosage: 2 Df, Tid If Pain, start time:
Jan 26, 2011), combined with:
  • Cordarone (1 Df, 5 Days Per Week)
  • Tracleer (125 Mg, 2x/day)
  • Imovane (1 Df, Daily In The Bedtime)
  • Havlane (1 Df If Awaking During The Night)
  • Domperidone (1 Df In The Midday)
  • Nexium (20 Mg, Unk)
and developed a serious reaction and side effect(s): Jaundice Cholestatic after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Spasfon treatment in male patients, resulting in Jaundice Cholestatic side effect. The patient was hospitalized.
Spasfon Side Effect Report#7563609-2
Superinfection, Anal Fistula
This report suggests a potential Spasfon Superinfection side effect(s) that can have serious consequences. A 45-year-old female patient (weight: NA) from France was diagnosed with the following symptoms/conditions: abdominal pain,colitis ulcerative,hypothyroidism and used Spasfon (dosage: NA) starting
Sep 29, 2003. After starting Spasfon the patient began experiencing various side effects, including: Superinfection, Anal FistulaAdditional drugs used concurrently:
  • Remicade (5 Mg/kg)
  • Levothyroxine Sodium
  • Fivasa
The patient was hospitalized. Although Spasfon demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Superinfection, may still occur.
Spasfon Side Effect Report#7531436-8
Affective Disorder, Confusional State, Disorientation
This Affective Disorder problem was reported by a health professional from Italy. A 85-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Feb 01, 2011 this consumer started treatment with Spasfon (phloroglucinol) (phloroglucinol) (dosage: NA). The following drugs were being taken at the same time:
  • Orocal (calcium Carbonate) (calcium Carbonate)
  • Temerit (nebivolol) (nebivolol)
  • Dafalgan (paracetamol) (paracetamol)
  • Previscan (fluindione) (fluindione)
  • Depamide (valpromide) (600 Mg (600 Mg, 1 In 1 D), Oral)
  • Xanax
  • Escitalopram Oxalate
  • Noctamide (lormetazepam) (lormetazepam)
When using Spasfon (phloroglucinol) (phloroglucinol), the patient experienced the following unwanted symptoms/side effects: Affective Disorder, Confusional State, DisorientationThe 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 Affective Disorder, may become evident only after a product is in use by the general population.
Spasfon Side Effect Report#7511585-0
Renal Failure Acute
This Renal Failure Acute side effect was reported by a health professional from France. A 52-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Spasfon (drug dosage: NA), which was initiated on
Sep 30, 2004. Concurrently used drugs:
  • Ursolvan
  • Vitamin B1 And B6
  • Paracetamol
  • Zyvox (Bid)
  • Piperacillin And Tazobactam (4 G/0.5 G Twice Per Day)
  • Phytonadione
  • Omeprazole
.After starting to take Spasfon the consumer reported adverse symptoms, such as: Renal Failure AcuteThese side effects may potentially be related to Spasfon. The patient was hospitalized.
Spasfon Side Effect Report#7391666-5
Hypernatraemia, Transaminases Increased, Alanine Aminotransferase Increased, Blood Creatine Phosphokinase Increased
This is a report of a 5-year-old male patient (weight: NA) from France, suffering from the following health symptoms/conditions: NA, who was treated with Spasfon (dosage: Unk, start time:
Jan 01, 2011), combined with:
  • Bedelix (Unk)
  • Atarax (17 Ml, Daily)
  • Eductyl (Unk)
  • Trimebutine Maleate (Unk)
  • Chloral Hydrate
  • Advil Liqui-gels (Unk)
  • Duphalac (Unk)
  • Atarax (10 Ml, Daily)
and developed a serious reaction and side effect(s): Hypernatraemia, Transaminases Increased, Alanine Aminotransferase Increased, Blood Creatine Phosphokinase Increased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Spasfon treatment in male patients, resulting in Hypernatraemia side effect. The patient was hospitalized.
Spasfon Side Effect Report#7367219-1
Pulmonary Hypertension, Oedema Peripheral, Neoplasm Malignant, Anaemia
This report suggests a potential Spasfon Death side effect(s) that can have serious consequences. A 57-year-old female patient (weight: NA) from France was diagnosed with the following symptoms/conditions: pain and used Spasfon (dosage: NA) starting NS. After starting Spasfon the patient began experiencing various side effects, including: Pulmonary Hypertension, Oedema Peripheral, Neoplasm Malignant, AnaemiaAdditional drugs used concurrently:
  • Acetaminophen And Tramadol Hcl
  • Revatio (20 Mg, 3x/day)
  • Ambrisentan
Although Spasfon demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Death, may still occur.
Spasfon Side Effect Report#7353477-6
Cytolytic Hepatitis
This Cytolytic Hepatitis problem was reported by a physician from France. A 90-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jan 11, 2011 this consumer started treatment with Spasfon (dosage: 1 Unit 3 Times A Day). The following drugs were being taken at the same time:
  • Atarax (25 Mg, Unk)
  • Colchicine (1 Mg, Unk)
  • Calciparine (5000 Iu, 2x/day)
  • Kardegic (160 Mg, Unk)
  • Augmentin '125' (1 Df, 3x/day)
  • Amiodarone (100 Mg, Unk)
  • Seresta (Unk)
  • Seloken (25 Mg, 2x/day)
When using Spasfon, the patient experienced the following unwanted symptoms/side effects: Cytolytic HepatitisAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Cytolytic Hepatitis, may become evident only after a product is in use by the general population.
Spasfon Side Effect Report#7279149-4
Lactic Acidosis, Hyperkalaemia, Renal Failure Acute, Accidental Overdose
This Lactic Acidosis side effect was reported by a health professional from France. A 87-year-old female patient (weight:NA) experienced the following symptoms/conditions: gastrointestinal disorder,hypertension,type 2 diabetes mellitus.The patient was prescribed Spasfon (drug dosage: Unk), which was initiated on
Nov 14, 2010. Concurrently used drugs:
  • Amlor (5 Mg, 1x/day)
  • Glucophage (1000 Mg, 2x/day)
  • Lasix (20 Mg, 1x/day)
  • Tanakan (2 Df Daily)
  • Olmetec (40 Mg, 1x/day)
  • Aluminum Hydroxide And Magnesium Trisilicate (Unk)
.After starting to take Spasfon the consumer reported adverse symptoms, such as: Lactic Acidosis, Hyperkalaemia, Renal Failure Acute, Accidental OverdoseThese side effects may potentially be related to Spasfon.
Spasfon Side Effect Report#5151989-7
Assisted Delivery, Brachial Plexus Injury, Large For Dates Baby, Peripheral Nerve Palsy, Shoulder Dystocia
This is a report of a female patient (weight: NA) from France, suffering from the following health symptoms/conditions: NA, who was treated with Spasfon (dosage: NA, start time: NS), combined with:
  • Syntocinon (Unk, Unk)
and developed a serious reaction and side effect(s): Assisted Delivery, Brachial Plexus Injury, Large For Dates Baby, Peripheral Nerve Palsy, Shoulder Dystocia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Spasfon treatment in female patients, resulting in Assisted Delivery side effect.



The appearance of Spasfon 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.

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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.

    Spasfon 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 Spasfon

    Side Effects reported to FDA: 17

    Spasfon safety alerts: No

    Reported deaths: 2

    Reported hospitalizations: 7

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