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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
on Feb 20, 2012 Female from FRANCE , 22 years of age, weighting 121.3 lb, was diagnosed with and was treated with Spasfon. Directly after, patient experienced the unwanted or unexpected Spasfon side effects: renal colic. Spasfon dosage: N/A.
Associated medications used:
  • Humira
  • Humira
  • Acetaminophen
  • Humira
  • Claritin
  • Clobetasol Propionate (1 Application)
Patient was hospitalized.

Back Pain, Malaise, Loss Of Consciousness
Patient was taking Spasfon (phloroglucinol, Trimethylphloroglucinol). Patient felt the following Spasfon side effects: back pain, malaise, loss of consciousness on Jan 06, 2012 from ITALY Additional patient health information: Female , 37 years of age, was diagnosed with and. Spasfon (phloroglucinol, Trimethylphloroglucinol) dosage: 2 Dosage Form (2 Dosage Forms,1 In 1 D),oral.
Multiple prescriptions taken:
  • Fosfomycin (fofomycin Trometamol) (3 Gram, Granulate) ((3 Gm,once),oral)


Lung Disorder
Adverse event was reported on Nov 23, 2011 by a Female taking Spasfon (Dosage: Unk) was diagnosed with and. Location: FRANCE , 68 years of age, weighting 121.3 lb, After Spasfon was administered, patient encountered several Spasfon side effects: lung disorder.
Multiple concurrent drugs taken:
  • Valsartan (Unk)
  • Temozolomide (120 Mg, Unk)
  • Lioresal (Unk)
  • Lexomil (Unk)
  • Medrol (Unk)
  • Bevacizumab (580 Mg, Unk)
  • Irinotecan Hcl (190 Mg, Unk)
  • Motilium (Unk)
Patient was hospitalized.

Eyelid Oedema, Eyelids Pruritus, Local Swelling
on Oct 07, 2011 Female from FRANCE , weighting 143.3 lb, was diagnosed with and was treated with Spasfon. Directly after, patient experienced the unwanted or unexpected Spasfon side effects: eyelid oedema, eyelids pruritus, local swelling. Spasfon dosage: On Request If Pain.
Associated medications used:
  • Humira (Induction Dose With 160mg)
  • Xanax (If Needed)
  • Pentasa (2 In 1 Day, 4 Gram, 2 Gigabecquerels)
  • Humira
  • Diane



Vulvovaginal Discomfort, Device Dislocation, Abortion Spontaneous, Pregnancy With Contraceptive Device
on Oct 03, 2010 Female from FRANCE , 29 years of age, weighting 134.5 lb, was treated with Spasfon. Patient felt the following Spasfon side effects: vulvovaginal discomfort, device dislocation, abortion spontaneous, pregnancy with contraceptive device. Spasfon dosage: N/A.
Multiple prescriptions taken:
  • Nuvaring
  • Ketoprofen


Cognitive Disorder, Aphasia, Disorientation, Incoherent, Confusional State, Abnormal Behaviour
Patient was taking Spasfon. After Spasfon was administered, patient encountered several Spasfon side effects: cognitive disorder, aphasia, disorientation, incoherent, confusional state, abnormal behaviour on Oct 07, 2011 from FRANCE Additional patient health information: Female , 79 years of age, . Spasfon dosage: 2 Df, 3x/day.
Multiple concurrent drugs taken:
  • Paracetamol (1 G, 3x/day)
  • Lyrica (Unk)
  • Lyrica
  • Levothyroxine Sodium (75 Ug, 1x/day)
  • Zolpidem (0.5 Df, 1x/day)
Patient was hospitalized.

Abortion Spontaneous, Pregnancy On Contraceptive, Maternal Exposure During Pregnancy
Adverse event was reported on Jul 13, 2011 by a Female taking Spasfon (Dosage: N/A) . Location: FRANCE , 29 years of age, weighting 134.5 lb, Directly after, patient experienced the unwanted or unexpected Spasfon side effects: abortion spontaneous, pregnancy on contraceptive, maternal exposure during pregnancy.
Associated medications used:
  • Ketoprofen
  • Nuvaring


Stillbirth
on Aug 16, 2011 Male from FRANCE , weighting 7.28 lb, was treated with Spasfon. Patient felt the following Spasfon side effects: stillbirth. Spasfon dosage: N/A.
Multiple prescriptions taken:
  • Omeprazole
  • Triphasil-21


Jaundice Cholestatic
on Jul 28, 2011 Male from FRANCE , 77 years of age, was diagnosed with and was treated with Spasfon. After Spasfon was administered, patient encountered several Spasfon side effects: jaundice cholestatic. Spasfon dosage: 2 Df, Tid If Pain.
Multiple concurrent drugs taken:
  • 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)
Patient was hospitalized.

Superinfection, Anal Fistula
Patient was taking Spasfon. Directly after, patient experienced the unwanted or unexpected Spasfon side effects: superinfection, anal fistula on Jun 10, 2011 from FRANCE Additional patient health information: Female , 45 years of age, weighting 198.4 lb, was diagnosed with and. Spasfon dosage: N/A.
Associated medications used:
  • Remicade (5 Mg/kg)
  • Levothyroxine Sodium
  • Fivasa
Patient was hospitalized.

Affective Disorder, Confusional State, Disorientation
Adverse event was reported on May 18, 2011 by a Female taking Spasfon (phloroglucinol) (phloroglucinol) (Dosage: N/A) . Location: ITALY , 85 years of age, Patient felt the following Spasfon side effects: affective disorder, confusional state, disorientation.
Multiple prescriptions taken:
  • 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)
Patient was hospitalized.

Renal Failure Acute
on May 23, 2011 Male from FRANCE , 52 years of age, was treated with Spasfon. After Spasfon was administered, patient encountered several Spasfon side effects: renal failure acute. Spasfon dosage: N/A.
Multiple concurrent drugs taken:
  • Ursolvan
  • Vitamin B1 And B6
  • Paracetamol
  • Zyvox (Bid)
  • Piperacillin And Tazobactam (4 G/0.5 G Twice Per Day)
  • Phytonadione
  • Omeprazole
Patient was hospitalized.

Hypernatraemia, Transaminases Increased, Alanine Aminotransferase Increased, Blood Creatine Phosphokinase Increased
on Mar 23, 2011 Male from FRANCE , child 5 years of age, weighting 37.48 lb, was treated with Spasfon. Directly after, patient experienced the unwanted or unexpected Spasfon side effects: hypernatraemia, transaminases increased, alanine aminotransferase increased, blood creatine phosphokinase increased. Spasfon dosage: Unk.
Associated medications used:
  • Bedelix (Unk)
  • Atarax (17 Ml, Daily)
  • Eductyl (Unk)
  • Trimebutine Maleate (Unk)
  • Chloral Hydrate
  • Advil Liqui-gels (Unk)
  • Duphalac (Unk)
  • Atarax (10 Ml, Daily)
Patient was hospitalized.

Pulmonary Hypertension, Oedema Peripheral, Neoplasm Malignant, Anaemia
Patient was taking Spasfon. Patient felt the following Spasfon side effects: pulmonary hypertension, oedema peripheral, neoplasm malignant, anaemia on Mar 18, 2011 from FRANCE Additional patient health information: Female , 57 years of age, was diagnosed with and. Spasfon dosage: N/A.
Multiple prescriptions taken:
  • Acetaminophen And Tramadol Hcl
  • Revatio (20 Mg, 3x/day)
  • Ambrisentan


Cytolytic Hepatitis
Adverse event was reported on Mar 08, 2011 by a Male taking Spasfon (Dosage: 1 Unit 3 Times A Day) . Location: FRANCE , 90 years of age, After Spasfon was administered, patient encountered several Spasfon side effects: cytolytic hepatitis.
Multiple concurrent drugs taken:
  • 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)


Lactic Acidosis, Hyperkalaemia, Renal Failure Acute, Accidental Overdose
on Feb 02, 2011 Female from FRANCE , 87 years of age, was diagnosed with and was treated with Spasfon. Directly after, patient experienced the unwanted or unexpected Spasfon side effects: lactic acidosis, hyperkalaemia, renal failure acute, accidental overdose. Spasfon dosage: Unk.
Associated medications used:
  • 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)


Assisted Delivery, Brachial Plexus Injury, Large For Dates Baby, Peripheral Nerve Palsy, Shoulder Dystocia
on Sep 25, 2006 Female from FRANCE , weighting 11.02 lb, was treated with Spasfon. Patient felt the following Spasfon side effects: assisted delivery, brachial plexus injury, large for dates baby, peripheral nerve palsy, shoulder dystocia. Spasfon dosage: N/A.
Multiple prescriptions taken:
  • Syntocinon (Unk, Unk)


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


    Track Online

  • User Sign In
  • Register to track your side effects

  • 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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    Safety Alerts, Active Ingredients, Usage Information

    More About Spasfon

    Side Effects reported to FDA: 17

    Spasfon safety alerts: No

    Reported deaths: 2

    Reported hospitalizations: 7

    Latest Spasfon clinical trials