Common Femibion Side Effects


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

Premature Baby (5)
Ventricular Septal Defect (4)
Hyperbilirubinaemia Neonatal (4)
Haemangioma Congenital (4)
Atrial Septal Defect (2)
Foetal Exposure During Pregnancy (2)
Maternal Exposure During Pregnancy (2)
Small For Dates Baby (2)
Pregnancy (1)
Pyelonephritis (1)
Neonatal Respiratory Distress Syndrome (1)
Neonatal Disorder (1)
Anaphylactic Shock (1)
Inguinal Hernia (1)
Congenital Aortic Valve Stenosis (1)
Cyanosis Neonatal (1)
Congenital Aortic Valve Incompetence (1)
Cardiac Murmur (1)
Abortion Missed (1)
Anaemia Neonatal (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.

Femibion Side Effects Reported to FDA



Femibion Side Effect Report#8450225-3
Ventricular Septal Defect
This is a report of a 0-year-old male patient (weight: NA) from Germany, suffering from the following health symptoms/conditions: NA, who was treated with Femibion (dosage: NA, start time: NS), combined with:
  • Clozapine
and developed a serious reaction and side effect(s): Ventricular Septal Defect after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Femibion treatment in male patients, resulting in Ventricular Septal Defect side effect.
Femibion Side Effect Report#8426759-4
Ventricular Septal Defect, Cardiac Murmur
This report suggests a potential Femibion Ventricular Septal Defect side effect(s) that can have serious consequences. A male patient (weight: NA) from Germany was diagnosed with the following symptoms/conditions: NA and used Femibion (dosage: Maternal Exposure:0.8 Mg Per Day) starting NS. After starting Femibion the patient began experiencing various side effects, including: Ventricular Septal Defect, Cardiac MurmurAdditional drugs used concurrently:
  • Clozapine (Maternal Exposure :50mg Per Day)
Although Femibion demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Ventricular Septal Defect, may still occur.
Femibion Side Effect Report#8424006-0
Ventricular Septal Defect, Foetal Exposure During Pregnancy
This Ventricular Septal Defect problem was reported by a physician from Germany. A male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Femibion (dosage: Maternal Dose: 0.8 Mg/day). The following drugs were being taken at the same time:
  • Clozapine (Maternal Dose: 50 Mg/day)
When using Femibion, the patient experienced the following unwanted symptoms/side effects: Ventricular Septal Defect, Foetal Exposure During PregnancyAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Ventricular Septal Defect, may become evident only after a product is in use by the general population.
Femibion Side Effect Report#8421354-5
Ventricular Septal Defect, Foetal Exposure During Pregnancy
This Ventricular Septal Defect side effect was reported by a health professional from Germany. A male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Femibion (drug dosage: Maternal Dose: 0.8 Mg/day), which was initiated on NS. Concurrently used drugs:
  • Clozapine (Maternal Dose: 50 Mg/day)
.After starting to take Femibion the consumer reported adverse symptoms, such as: Ventricular Septal Defect, Foetal Exposure During PregnancyThese side effects may potentially be related to Femibion.
Femibion Side Effect Report#8393525-8
Maternal Exposure During Pregnancy, Hypospadias, Hydrocele, Small For Dates Baby
This is a report of a 0-year-old male patient (weight: NA) from Germany, suffering from the following health symptoms/conditions: prophylaxis of neural tube defect, who was treated with Femibion (dosage: NA, start time:
Jul 02, 2011), combined with:
  • Cetirizine Hcl
  • Prednisolone
  • Metoprolol Tartrate (47.5 [mg/d ]/ + Precon, Since Several Years 2x23.75 Mg/d)
  • Arixtra
  • Monurol
  • Progesterone
  • Fragmin
  • Enoxaparin Sodium
and developed a serious reaction and side effect(s): Maternal Exposure During Pregnancy, Hypospadias, Hydrocele, Small For Dates Baby after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Femibion treatment in male patients, resulting in Maternal Exposure During Pregnancy side effect.
Femibion Side Effect Report#8288160-6
Pregnancy, Pyelonephritis
This report suggests a potential Femibion Pregnancy side effect(s) that can have serious consequences. A 28-year-old female patient (weight: NA) from Denmark was diagnosed with the following symptoms/conditions: vitamin supplementation,depression and used Femibion (dosage: 0.4 Mg) starting NS. After starting Femibion the patient began experiencing various side effects, including: Pregnancy, PyelonephritisAdditional drugs used concurrently:
  • Escitalopram (20 Mg)
  • Escitalopram (10 Mg)
  • Escitalopram (20 Mg)
The patient was hospitalized. Although Femibion demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pregnancy, may still occur.
Femibion Side Effect Report#8176779-2
Atrial Septal Defect, Haemangioma, Inguinal Hernia, Bradycardia Neonatal, Maternal Exposure During Pregnancy, Hyperbilirubinaemia, Premature Baby, Anaemia Neonatal, Neonatal Respiratory Distress Syndrome
This Atrial Septal Defect problem was reported by a health professional from Germany. A 0-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jan 26, 2009 this consumer started treatment with Femibion (dosage: 0-27.5 Gw). The following drugs were being taken at the same time:
  • Remicade (300 [mg/every 8 Wks ])
  • Prednisolone (15 [mg/d ])
  • Azathioprine (150 [mg/d ]/ Week 0-4.3 And 18-27.5)
  • Methylprednisolone
When using Femibion, the patient experienced the following unwanted symptoms/side effects: Atrial Septal Defect, Haemangioma, Inguinal Hernia, Bradycardia Neonatal, Maternal Exposure During Pregnancy, Hyperbilirubinaemia, Premature Baby, Anaemia Neonatal, Neonatal Respiratory Distress SyndromeThe 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 Atrial Septal Defect, may become evident only after a product is in use by the general population.
Femibion Side Effect Report#7981717-9
Neonatal Disorder, Heart Rate Decreased
This Neonatal Disorder side effect was reported by a health professional from Germany. A female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Femibion (femibion) (drug dosage: NA), which was initiated on
Jul 11, 2010. Concurrently used drugs:
  • Venlafaxine (75 Mg, 1 D, Transplacental, 37.5 Mg, 1 D, Transplacental)
  • Venlafaxine (75 Mg, 1 D, Transplacental, 37.5 Mg, 1 D, Transplacental)
.After starting to take Femibion (femibion) the consumer reported adverse symptoms, such as: Neonatal Disorder, Heart Rate DecreasedThese side effects may potentially be related to Femibion (femibion). The patient was hospitalized.
Femibion Side Effect Report#7610293-5
Hyperbilirubinaemia Neonatal, Haemangioma Congenital, Premature Baby
This is a report of a female patient (weight: NA) from Germany, suffering from the following health symptoms/conditions: NA, who was treated with Femibion (calcium) (dosage: NA, start time:
Jul 07, 2009), combined with:
  • Paroxetine Hcl (See Image)
and developed a serious reaction and side effect(s): Hyperbilirubinaemia Neonatal, Haemangioma Congenital, Premature Baby after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Femibion (calcium) treatment in female patients, resulting in Hyperbilirubinaemia Neonatal side effect.
Femibion Side Effect Report#7562476-0
Congenital Aortic Valve Incompetence, Small For Dates Baby, Congenital Aortic Valve Stenosis, Cyanosis Neonatal, Atrial Septal Defect
This report suggests a potential Femibion Congenital Aortic Valve Incompetence side effect(s) that can have serious consequences. A male patient (weight: NA) from Germany was diagnosed with the following symptoms/conditions: prophylaxis of neural tube defect,gastric disorder,trigeminal neuralgia,depression,pain,gestational diabetes and used Femibion (dosage: 0.4 Mg, Unk) starting
Mar 28, 2009. After starting Femibion the patient began experiencing various side effects, including: Congenital Aortic Valve Incompetence, Small For Dates Baby, Congenital Aortic Valve Stenosis, Cyanosis Neonatal, Atrial Septal DefectAdditional drugs used concurrently:
  • Omeprazole (40 Mg, Unk)
  • Lyrica (550 Mg, Unk)
  • Fluoxetine Hcl (Unk)
  • Novalgin (2250 Mg, Unk)
  • Huminsulin Normal 100 (Unk)
The patient was hospitalized. Although Femibion demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Congenital Aortic Valve Incompetence, may still occur.
Femibion Side Effect Report#7558862-5
Hyperbilirubinaemia Neonatal, Premature Baby, Haemangioma Congenital
This Hyperbilirubinaemia Neonatal problem was reported by a physician from United States. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jul 07, 2009 this consumer started treatment with Femibion (folic Acid) (dosage: NA). The following drugs were being taken at the same time:
  • Paroxetine Hcl (20-10mg -daily-transpla)
When using Femibion (folic Acid), the patient experienced the following unwanted symptoms/side effects: Hyperbilirubinaemia Neonatal, Premature Baby, Haemangioma CongenitalAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hyperbilirubinaemia Neonatal, may become evident only after a product is in use by the general population.
Femibion Side Effect Report#7546775-4
Premature Baby, Haemangioma Congenital, Hyperbilirubinaemia Neonatal
This Premature Baby side effect was reported by a health professional from Netherlands. A female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Femibion (drug dosage: NA), which was initiated on
Sep 01, 2009. Concurrently used drugs:
  • Paroxetine Hydrochloride (20 Mg, Qd)
  • Antihypertensives (Unk)
  • Paroxetine Hydrochloride (10 Mg, Qd)
  • Paroxetine Hydrochloride (20 Mg, Qd)
.After starting to take Femibion the consumer reported adverse symptoms, such as: Premature Baby, Haemangioma Congenital, Hyperbilirubinaemia NeonatalThese side effects may potentially be related to Femibion.
Femibion Side Effect Report#7513717-7
Haemangioma Congenital, Hyperbilirubinaemia Neonatal, Premature Baby
This is a report of a female patient (weight: NA) from Germany, suffering from the following health symptoms/conditions: prophylaxis of neural tube defect, who was treated with Femibion (dosage: Mother Dose: 0.4 Mg, Qd, start time: NS), combined with:
  • Paroxetine Hcl (20 Mg/day From Gw 9 Until Delivery)
  • Paroxetine Hcl (Mother Dose: Until Gw 6)
  • Paroxetine Hcl (10 Mg/day From Gw 7-8)
and developed a serious reaction and side effect(s): Haemangioma Congenital, Hyperbilirubinaemia Neonatal, Premature Baby after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Femibion treatment in female patients, resulting in Haemangioma Congenital side effect.
Femibion Side Effect Report#7508269-1
Abortion Missed
This report suggests a potential Femibion Abortion Missed side effect(s) that can have serious consequences. A female patient (weight: NA) from Germany was diagnosed with the following symptoms/conditions: prophylaxis of neural tube defect,borderline personality disorder,obsessive-compulsive disorder and used Femibion (dosage: 0.4 [mg/d ]) starting NS. After starting Femibion the patient began experiencing various side effects, including: Abortion MissedAdditional drugs used concurrently:
  • Lamotrigine (150 [mg/d ])
  • Fluoxetine Hcl (30 [mg/d ])
Although Femibion demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Abortion Missed, may still occur.
Femibion Side Effect Report#7269176-5
Vaginal Haemorrhage, Anaphylactic Shock
This Vaginal Haemorrhage problem was reported by a physician from Germany. A 25-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Apr 16, 2010 this consumer started treatment with Femibion (folic Acid And Methylfolate) (dosage: NA). The following drugs were being taken at the same time:
  • Wilate (3600 Iu, Iv)
When using Femibion (folic Acid And Methylfolate), the patient experienced the following unwanted symptoms/side effects: Vaginal Haemorrhage, Anaphylactic ShockAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Vaginal Haemorrhage, may become evident only after a product is in use by the general population.



The appearance of Femibion 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.

What are common Femibion Side Effects for Women?

Women Side Effects Reports
Premature Baby 5
Haemangioma Congenital 4
Hyperbilirubinaemia Neonatal 4
Abortion Missed 1
Anaemia Neonatal 1
Anaphylactic Shock 1
Atrial Septal Defect 1
Bradycardia Neonatal 1
Haemangioma 1
Heart Rate Decreased 1

What are common Femibion Side Effects for Men?

Men Side Effects Reports
Ventricular Septal Defect 4
Foetal Exposure During Pregnancy 2
Small For Dates Baby 2
Atrial Septal Defect 1
Cardiac Murmur 1
Congenital Aortic Valve Incompetence 1
Congenital Aortic Valve Stenosis 1
Cyanosis Neonatal 1
Hydrocele 1
Hypospadias 1

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.

    Femibion 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 Femibion

    Side Effects reported to FDA: 15

    Femibion safety alerts: No

    Reported hospitalizations: 3

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