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.
Orthomol Side Effects Reported to FDA
Orthomol Side Effect Report#8306135-5 Stillbirth, Maternal Exposure During Pregnancy, Cholestasis, Influenza Like Illness
Azathioprine (150 [mg/d ]/ Since June 2010. Probably Taken Until Delivery.)
Atarax (37.5 [mg/d ]/ Probably Taken Until Delivery. Dosage Was Elevated From 25 To 37.5 Mg/d On October, 12)
and developed a serious reaction and side effect(s): Stillbirth, Maternal Exposure During Pregnancy, Cholestasis, Influenza Like Illness after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Orthomol treatment in female patients, resulting in Stillbirth side effect.
Orthomol Side Effect Report#8208063-2 Premature Baby, Pierre Robin Syndrome, Cleft Palate
This report suggests a potential Orthomol NatalPremature Baby 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,depression,pre-eclampsia and used Orthomol Natal (dosage: 0.4 Mg/d) starting
Jun 01, 2009. After starting Orthomol Natal the patient began experiencing various side effects, including: Premature Baby, Pierre Robin Syndrome, Cleft PalateAdditional drugs used concurrently:
Insidon (100 Mg/d Taken Until Gw 10)
Citalopram (40 Mg/d Taken Until Gw 10)
Valdoxan (25 Mg/d)
The patient was hospitalized and became disabled. Although Orthomol Natal demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Premature Baby, may still occur.
Orthomol Side Effect Report#7407340-2 Basal Cell Carcinoma
This Basal Cell Carcinoma problem was reported by a consumer or non-health professional from Switzerland. A 83-year-old patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Aug 20, 2008 this consumer started treatment with Orthomol Product Nos (dosage: NA). The following drugs were being taken at the same time:
When using Orthomol Product Nos, the patient experienced the following unwanted symptoms/side effects: Basal Cell CarcinomaThe 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 Basal Cell Carcinoma, may become evident only after a product is in use by the general population.
The appearance of Orthomol 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.
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
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:
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.
Orthomol 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.