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Spasfon Side Effects

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.

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.

Spasfon Side Effects Reported to FDA

The following 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.


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.
Renal Colic
This is a report of a 22-year-old female patient (weight: NA) from FRANCE, suffering from the following 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). The consumer presented with:
  • Renal Colic
which developed 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.

Back Pain, Malaise, Loss Of Consciousness
This report suggests a potential Spasfon (phloroglucinol, Trimethylphloroglucinol) Back Pain, Malaise, Loss Of Consciousness 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. Soon after starting Spasfon (phloroglucinol, Trimethylphloroglucinol) the patient began experiencing various side effects, including:
  • Back Pain
  • Malaise
  • Loss Of Consciousness
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.

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 commencing Spasfon, the patient experienced the following unwanted symptoms/side effects:
  • Lung Disorder
The 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.

Eyelid Oedema, Eyelids Pruritus, Local Swelling
This is a report of a female patient (weight: NA) from FRANCE. The patient developed the following symptoms/conditions: crohn's disease and was treated with Spasfon (dosage: On Request If Pain) starting 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
Soon after that, the consumer experienced the following side effects:
  • Eyelid Oedema
  • Eyelids Pruritus
  • Local Swelling
This opens a possibility that Spasfon treatment could cause the above reactions, including eyelid oedema, and some female subjects may be more susceptible.


Vulvovaginal Discomfort, Device Dislocation, Abortion Spontaneous, Pregnancy With Contraceptive Device
A 29-year-old female patient (weight: NA) from FRANCE with the following symptoms/conditions: NA started Spasfon treatment (dosage: NA) on Dec 03, 2010. Soon after starting Spasfon treatment, the subject experienced various side effects, including:
  • Vulvovaginal Discomfort
  • Device Dislocation
  • Abortion Spontaneous
  • Pregnancy With Contraceptive Device
Concurrently used drugs:
  • Nuvaring
  • Ketoprofen
This finding indicates that some female patients could be more vulnerable to Spasfon.

Cognitive Disorder, Aphasia, Disorientation, Incoherent, Confusional State, Abnormal Behaviour
A 79-year-old female patient from FRANCE (weight: NA) experienced symptoms, such as: NA and was treated with Spasfon(dosage: 2 Df, 3x/day). The treatment was initiated on Feb 01, 2011. After that a consumer reported the following side effect(s):
  • Cognitive Disorder
  • Aphasia
  • Disorientation
  • Incoherent
  • Confusional State
  • Abnormal Behaviour
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Spasfon efficacy:
  • Paracetamol (1 G, 3x/day)
  • Lyrica (Unk)
  • Lyrica
  • Levothyroxine Sodium (75 Ug, 1x/day)
  • Zolpidem (0.5 Df, 1x/day)
The patient was hospitalized.

Abortion Spontaneous, Pregnancy On Contraceptive, Maternal Exposure During Pregnancy
In this report, Spasfon was administered for the following condition: NA.A 29-year-old female consumer from FRANCE (weight: NA) started Spasfon treatment (dosage: NA) on NS.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Abortion Spontaneous
  • Pregnancy On Contraceptive
  • Maternal Exposure During Pregnancy
A possible interaction with other drugs could have contributed to this reaction:
  • Ketoprofen
  • Nuvaring
Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Spasfon treatment could be related to the listed above side effect(s).

Stillbirth
This is a report of the following Spasfon side effect(s):
  • Stillbirth
A male patient from FRANCE (weight: NA) presented with the following condition: NA and received a treatment with Spasfon (dosage: NA) starting: Mar 26, 2011.The following concurrently used drugs could have generated interactions:
  • Omeprazole
  • Triphasil-21
This report suggests that a Spasfon treatment could be associated with the listed above side effect(s).

Jaundice Cholestatic
This Spasfon report was submitted by a 77-year-old male consumer from FRANCE (weight: NA). The patient was diagnosed with: pain,atrial fibrillation,pulmonary arterial hypertension and Spasfon was administered (dosage: 2 Df, Tid If Pain) starting: Jan 26, 2011. The consumer developed a set of symptoms:
  • Jaundice Cholestatic
Other drugs used simultaneously:
  • 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)
The patient was hospitalized.Those unexpected symptoms could be linked to a Spasfon treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Superinfection, Anal Fistula
This is a report of a possible correlation between Spasfon use and the following symptoms/side effect(s):
  • Superinfection
  • Anal Fistula
which could contribute to an assessment of Spasfon risk profile.A 45-year-old female consumer from FRANCE (weight: NA) was suffering from abdominal pain,colitis ulcerative,hypothyroidism and was treated with Spasfon (dosage: NA) starting Sep 29, 2003.Other concurrent medications:
  • Remicade (5 Mg/kg)
  • Levothyroxine Sodium
  • Fivasa
The patient was hospitalized.

Affective Disorder, Confusional State, Disorientation
A 85-year-old female patient from ITALY (weight: NA) presented with the following symptoms: NA and after a treatment with Spasfon (phloroglucinol) (phloroglucinol) (dosage: NA) experienced the following side effect(s):
  • Affective Disorder
  • Confusional State
  • Disorientation
The treatment was started on Feb 01, 2011. Spasfon (phloroglucinol) (phloroglucinol) was used in combination with the following drugs:
  • 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)
The patient was hospitalized.This report could alert potential Spasfon (phloroglucinol) (phloroglucinol) consumers.

Renal Failure Acute
In this report, a 52-year-old male patient from FRANCE (weight: NA) was affected by a possible Spasfon side effect.The patient was diagnosed with NA. After a treatment with Spasfon (dosage: NA, start date: Sep 30, 2004), the patient experienced the following side effect(s):
  • Renal Failure Acute
The following simultaneously used drugs could have led to this reaction:
  • Ursolvan
  • Vitamin B1 And B6
  • Paracetamol
  • Zyvox (Bid)
  • Piperacillin And Tazobactam (4 G/0.5 G Twice Per Day)
  • Phytonadione
  • Omeprazole
The patient was hospitalized.The findings here stress that side effects should be taken into consideration when evaluating a Spasfon treatment.

Hypernatraemia, Transaminases Increased, Alanine Aminotransferase Increased, Blood Creatine Phosphokinase Increased
This is a report of a 5-year-old male patient from FRANCE (weight: NA), who used Spasfon (dosage: Unk) for a treatment of NA. After starting a treatment on Jan 01, 2011, the patient experienced the following side effect(s):
  • Hypernatraemia
  • Transaminases Increased
  • Alanine Aminotransferase Increased
  • Blood Creatine Phosphokinase Increased
The following drugs could possibly have interacted with the Spasfon treatment
  • Bedelix (Unk)
  • Atarax (17 Ml, Daily)
  • Eductyl (Unk)
  • Trimebutine Maleate (Unk)
  • Chloral Hydrate
  • Advil Liqui-gels (Unk)
  • Duphalac (Unk)
  • Atarax (10 Ml, Daily)
The patient was hospitalized.Taken together, these observations suggest that a Spasfon treatment could be related to side effect(s), such as Hypernatraemia, Transaminases Increased, Alanine Aminotransferase Increased, Blood Creatine Phosphokinase Increased.

Pulmonary Hypertension, Oedema Peripheral, Neoplasm Malignant, Anaemia
This death side effect was reported by a physician from FRANCE. A 57-year-old female patient (weight:NA) experienced the following symptoms/conditions: pain. The patient was prescribed Spasfon (dosage: NA), which was started on NS. Concurrently used drugs:
  • Acetaminophen And Tramadol Hcl
  • Revatio (20 Mg, 3x/day)
  • Ambrisentan
When starting to take Spasfon the consumer reported the following symptoms:
  • Pulmonary Hypertension
  • Oedema Peripheral
  • Neoplasm Malignant
  • Anaemia
These side effects may potentially be related to Spasfon.

Cytolytic Hepatitis
This is a Spasfon side effect report of a 90-year-old male patient (weight:NA) from FRANCE, suffering from the following symptoms/conditions: NA, who was treated with Spasfon (dosage:1 Unit 3 Times A Day, start time: Jan 11, 2011), combined with:
  • 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)
, and developed a serious reaction and a cytolytic hepatitis side effect. The patient presented with:
  • Cytolytic Hepatitis
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Spasfon treatment in male patients suffering from NA, resulting in cytolytic hepatitis.

Lactic Acidosis, Hyperkalaemia, Renal Failure Acute, Accidental Overdose
This report suggests a potential Spasfon lactic acidosis side effect(s) that can have serious consequences. A 87-year-old female patient from FRANCE (weight:NA) was diagnosed with the following health condition(s): gastrointestinal disorder,hypertension,type 2 diabetes mellitus and used Spasfon (dosage: Unk) starting Nov 14, 2010. Soon after starting Spasfon the patient began experiencing various side effects, including:
  • Lactic Acidosis
  • Hyperkalaemia
  • Renal Failure Acute
  • Accidental Overdose
Drugs used concurrently:
  • 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)
Although Spasfon demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as lactic acidosis, may still occur.

Assisted Delivery, Brachial Plexus Injury, Large For Dates Baby, Peripheral Nerve Palsy, Shoulder Dystocia
This assisted delivery problem was reported by a physician from FRANCE. A female patient (weight: NA) was diagnosed with the following medical condition(s): NA.On NS a consumer started treatment with Spasfon (dosage: NA). The following drugs/medications were being taken at the same time:
  • Syntocinon (Unk, Unk)
When commencing Spasfon, the patient experienced the following unwanted symptoms /side effects:
  • Assisted Delivery
  • Brachial Plexus Injury
  • Large For Dates Baby
  • Peripheral Nerve Palsy
  • Shoulder Dystocia
Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as assisted delivery, may become evident only after a product is in use by the general population.



Keep Track of Side Effects

Note Your Observations

It is really important to keep of your 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

    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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    More About Spasfon

    Side Effects reported to FDA: 17

    Spasfon safety alerts: No

    Reported deaths: 2

    Reported hospitalizations: 7

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