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Novynette Side Effects

Common Novynette Side Effects


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

Fatigue (2)
Local Swelling (2)
Thrombosis (2)
Limb Discomfort (2)
Somnolence (1)
Skin Discolouration (1)
Splenomegaly (1)
Vena Cava Filter Insertion (1)
Visual Acuity Reduced (1)
Sensation Of Heaviness (1)
Vasodilatation (1)
Syncope (1)
Mesenteric Artery Thrombosis (1)
Oesophageal Varices Haemorrhage (1)
Pain In Extremity (1)
Nausea (1)
Myocardial Rupture (1)
Hepatic Vein Thrombosis (1)
Migraine (1)
Pulmonary Embolism (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.

Novynette Side Effects Reported to FDA

The following Novynette 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 Novynette 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.
Splenomegaly, Vasodilatation, Oesophageal Varices Haemorrhage, Gastrointestinal Perforation, Gastrointestinal Ischaemia, Gallbladder Obstruction, Hepatic Function Abnormal, Mesenteric Artery Thrombosis, Hepatic Vein Thrombosis
This is a report of a 18-year-old female patient (weight: NA) from DK, suffering from the following symptoms/conditions: contraception, who was treated with Novynette (dosage: 1 Df, Qd, start time: Apr 02, 2009), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Splenomegaly
  • Vasodilatation
  • Oesophageal Varices Haemorrhage
  • Gastrointestinal Perforation
  • Gastrointestinal Ischaemia
  • Gallbladder Obstruction
  • Hepatic Function Abnormal
  • Mesenteric Artery Thrombosis
  • Hepatic Vein Thrombosis
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Novynette treatment in female patients, resulting in splenomegaly side effect. The patient was hospitalized.

Vena Cava Filter Insertion, Back Pain, Thrombosis, Limb Discomfort, Local Swelling, Skin Discolouration
This report suggests a potential Novynette Vena Cava Filter Insertion, Back Pain, Thrombosis, Limb Discomfort, Local Swelling, Skin Discolouration side effect(s) that can have serious consequences. A 17-year-old female patient (weight: NA) from DK was diagnosed with the following symptoms/conditions: contraception and used Novynette (dosage: NA) starting 201101. Soon after starting Novynette the patient began experiencing various side effects, including:
  • Vena Cava Filter Insertion
  • Back Pain
  • Thrombosis
  • Limb Discomfort
  • Local Swelling
  • Skin Discolouration
Drugs used concurrently: NA.The patient was hospitalized. Although Novynette demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as vena cava filter insertion, may still occur.

Hemiparesis, Dehydration, Apathy, Diarrhoea, Fatigue, Cerebral Thrombosis, Somnolence, Headache, Asthenia
This Hemiparesis, Dehydration, Apathy, Diarrhoea, Fatigue, Cerebral Thrombosis, Somnolence, Headache, Asthenia problem was reported by a health professional from DK. A 15-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: menstruation irregular. On 200904 this consumer started treatment with Novynette (dosage: NA). The following drugs were being taken at the same time: NA. When commencing Novynette, the patient experienced the following unwanted symptoms/side effects:
  • Hemiparesis
  • Dehydration
  • Apathy
  • Diarrhoea
  • Fatigue
  • Cerebral Thrombosis
  • Somnolence
  • Headache
  • Asthenia
The patient was hospitalized and became disabled.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as hemiparesis, may become evident only after a product is in use by the general population.

Syncope, Thrombosis, Pulmonary Embolism, Pain In Extremity, Local Swelling, Dyspnoea, Limb Discomfort, Sensation Of Heaviness, Fatigue
This is a report of a 26-year-old female patient (weight: NA) from DK. The patient developed the following symptoms/conditions: contraception,dysmenorrhoea and was treated with Novynette (dosage: NA) starting NS. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Syncope
  • Thrombosis
  • Pulmonary Embolism
  • Pain In Extremity
  • Local Swelling
  • Dyspnoea
  • Limb Discomfort
  • Sensation Of Heaviness
  • Fatigue
The patient was hospitalized and became disabled. This opens a possibility that Novynette treatment could cause the above reactions, including syncope, and some female subjects may be more susceptible.


Acute Myocardial Infarction, Cardiac Tamponade, Myocardial Rupture, Coronary Artery Thrombosis, Chest Pain, Migraine, Dizziness, Nausea
A 32-year-old female patient (weight: NA) from COUNTRY NOT SPECIFIED with the following symptoms/conditions: contraception started Novynette treatment (dosage: 1 Df, Qd) on Jan 04, 2008. Soon after starting Novynette treatment, the subject experienced various side effects, including:
  • Acute Myocardial Infarction
  • Cardiac Tamponade
  • Myocardial Rupture
  • Coronary Artery Thrombosis
  • Chest Pain
  • Migraine
  • Dizziness
  • Nausea
Concurrently used drugs: NA. This finding indicates that some female patients could be more vulnerable to Novynette.

Depression, Visual Acuity Reduced, Weight Increased
A 16-year-old female patient from DENMARK (weight: NA) experienced symptoms, such as: oral contraception and was treated with Novynette(dosage: 1 Tab(s), 21d/28d). The treatment was initiated on Jul 12, 2006. After that a consumer reported the following side effect(s):
  • Depression
  • Visual Acuity Reduced
  • Weight Increased
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Novynette efficacy:
  • Yasmin (1 Tab(s), 21d/28d)




Top 10 Novynette Side Effects for Men

Men Side EffectsReports

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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