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Trinessa Side Effects

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Common Trinessa Side Effects


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

Nausea (7)
Metrorrhagia (6)
Pregnancy On Oral Contraceptive (6)
Depression (6)
Cholelithiasis (6)
Abortion Spontaneous (5)
Acne (5)
Pulmonary Embolism (5)
Menorrhagia (4)
Off Label Use (4)
Dizziness (4)
Headache (4)
Abdominal Pain Upper (4)
Abdominal Pain (3)
Cerebrovascular Accident (3)
Loss Of Consciousness (3)
Vomiting (3)
Mood Swings (2)
Injury (2)
Menstruation Irregular (2)

➢ 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.

Trinessa Side Effects Reported to FDA



Trinessa Side Effect Report#9858168
Deep Vein Thrombosis
This is a report of a 31-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: contraception, who was treated with Trinessa (dosage: NA, start time: 201101), combined with: NA. and developed a serious reaction and side effect(s): Deep Vein Thrombosis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Trinessa treatment in female patients, resulting in Deep Vein Thrombosis side effect. The patient was hospitalized.
Trinessa Side Effect Report#9820231
Pulmonary Embolism
This report suggests a potential Trinessa Pulmonary Embolism side effect(s) that can have serious consequences. A 20-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: contraception and used Trinessa (dosage: 1 Pill) starting
Sep 04, 2013. After starting Trinessa the patient began experiencing various side effects, including: Pulmonary EmbolismAdditional drugs used concurrently:
  • Multivitamin
The patient was hospitalized. Although Trinessa demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pulmonary Embolism, may still occur.
Trinessa Side Effect Report#9802855
Depression
This Depression problem was reported by a consumer or non-health professional from US. A 35-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: acne,ear infection. On
Dec 25, 2013 this consumer started treatment with Trinessa (dosage: 1 Pill). The following drugs were being taken at the same time:
  • Amoxicillin (1 Pill)
When using Trinessa, the patient experienced the following unwanted symptoms/side effects: DepressionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Depression, may become evident only after a product is in use by the general population.
Trinessa Side Effect Report#9360402
Nausea, Vomiting, Haemorrhage
This Nausea side effect was reported by a physician from US. A 38-year-old female patient (weight:NA) experienced the following symptoms/conditions: menopause.The patient was prescribed Trinessa (drug dosage: NA), which was initiated on
Jun 25, 2010. Concurrently used drugs:
  • Loestrin
.After starting to take Trinessa the consumer reported adverse symptoms, such as: Nausea, Vomiting, HaemorrhageThese side effects may potentially be related to Trinessa.
Trinessa Side Effect Report#9341488
Hemiparesis, Dyspnoea, Speech Disorder, Abasia, Headache, Hyperhidrosis, Off Label Use, Dizziness, Decreased Appetite
This is a report of a 13-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: menstrual cycle management,dyspnoea,dry skin, who was treated with Trinessa 28 (dosage: NA, start time: 201301), combined with:
  • Procrin (Whenever Required)
  • Elidel (Whenever Required)
and developed a serious reaction and side effect(s): Hemiparesis, Dyspnoea, Speech Disorder, Abasia, Headache, Hyperhidrosis, Off Label Use, Dizziness, Decreased Appetite after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Trinessa 28 treatment in female patients, resulting in Hemiparesis side effect.
Trinessa Side Effect Report#9282907
Pulmonary Embolism, Menorrhagia, Pain In Extremity
This report suggests a potential Trinessa Pulmonary Embolism side effect(s) that can have serious consequences. A 37-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: menorrhagia,diabetes mellitus,type 2 diabetes mellitus,hypertension,hypothyroidism and used Trinessa (dosage: For 10 Day And Then Discontinued) starting
Dec 01, 2010. After starting Trinessa the patient began experiencing various side effects, including: Pulmonary Embolism, Menorrhagia, Pain In ExtremityAdditional drugs used concurrently:
  • Glipizide
  • Metformin
  • Lisinopril
  • Levothyroxine
  • Anti-hypertensive
The patient was hospitalized. Although Trinessa demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pulmonary Embolism, may still occur.
Trinessa Side Effect Report#9280429
Hepatic Adenoma, Blood Pressure Abnormal, Malaise, Varicose Vein, Liver Disorder
This Hepatic Adenoma problem was reported by a consumer or non-health professional from US. A 32-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: contraception. On
Apr 01, 2005 this consumer started treatment with Trinessa (dosage: NA). The following drugs were being taken at the same time: NA. When using Trinessa, the patient experienced the following unwanted symptoms/side effects: Hepatic Adenoma, Blood Pressure Abnormal, Malaise, Varicose Vein, Liver DisorderThe 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 Hepatic Adenoma, may become evident only after a product is in use by the general population.
Trinessa Side Effect Report#9028290
Fungal Infection, Disease Recurrence, Vulvovaginal Discomfort
This Fungal Infection side effect was reported by a consumer or non-health professional from US. A 23-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Trinessa (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Levothyroxine
.After starting to take Trinessa the consumer reported adverse symptoms, such as: Fungal Infection, Disease Recurrence, Vulvovaginal DiscomfortThese side effects may potentially be related to Trinessa.
Trinessa Side Effect Report#8990673
Breast Swelling
This is a report of a female patient (weight: NA) from US, suffering from the following health symptoms/conditions: contraception, who was treated with Trinessa (dosage: NA, start time:
May 01, 2012), combined with: NA. and developed a serious reaction and side effect(s): Breast Swelling after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Trinessa treatment in female patients, resulting in Breast Swelling side effect.
Trinessa Side Effect Report#8953268
Suicidal Ideation, Depression, Anxiety, Eating Disorder, Crying, Bacterial Infection, Alopecia, Fatigue, Vomiting
This report suggests a potential Trinessa Suicidal Ideation side effect(s) that can have serious consequences. A female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: oral contraception and used Trinessa (dosage: NA) starting 2010. After starting Trinessa the patient began experiencing various side effects, including: Suicidal Ideation, Depression, Anxiety, Eating Disorder, Crying, Bacterial Infection, Alopecia, Fatigue, VomitingAdditional drugs used concurrently: NA. Although Trinessa demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Suicidal Ideation, may still occur.
Trinessa Side Effect Report#8769730
Amnesia, Anxiety
This Amnesia problem was reported by a consumer or non-health professional from US. A 16-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: contraception. On
Jun 19, 2012 this consumer started treatment with Trinessa (dosage: NA). The following drugs were being taken at the same time:
  • Ethinyl Estradiol/norgestimate
When using Trinessa, the patient experienced the following unwanted symptoms/side effects: Amnesia, AnxietyAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Amnesia, may become evident only after a product is in use by the general population.
Trinessa Side Effect Report#8418933
Multiple Sclerosis
This Multiple Sclerosis side effect was reported by a consumer or non-health professional from US. A female patient (weight:NA) experienced the following symptoms/conditions: contraception.The patient was prescribed Trinessa (drug dosage: NA), which was initiated on 201008. Concurrently used drugs: NA..After starting to take Trinessa the consumer reported adverse symptoms, such as: Multiple SclerosisThese side effects may potentially be related to Trinessa.
Trinessa Side Effect Report#8214278-X
Pulmonary Embolism, Pulmonary Infarction
This is a report of a 17-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Trinessa-28 (dosage: NA, start time: NS), combined with:
  • Yaz
and developed a serious reaction and side effect(s): Pulmonary Embolism, Pulmonary Infarction after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Trinessa-28 treatment in female patients, resulting in Pulmonary Embolism side effect. The patient was hospitalized.
Trinessa Side Effect Report#8093402
Coagulopathy, Blood Urine Present, Cerebrovascular Accident, Off Label Use, Contraindication To Medical Treatment
This report suggests a potential Trinessa Coagulopathy side effect(s) that can have serious consequences. A 16-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: contraception,menstruation irregular and used Trinessa (dosage: 1-1.5 Years, T Daily) starting NS. After starting Trinessa the patient began experiencing various side effects, including: Coagulopathy, Blood Urine Present, Cerebrovascular Accident, Off Label Use, Contraindication To Medical TreatmentAdditional drugs used concurrently: NA.The patient was hospitalized and became disabled. Although Trinessa demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Coagulopathy, may still occur.
Trinessa Side Effect Report#8093402
Coagulopathy, Blood Urine Present, Cerebrovascular Accident, Off Label Use, Contraindication To Medical Treatment
This Coagulopathy problem was reported by a consumer or non-health professional from US. A 16-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: contraception,menstruation irregular. On NS this consumer started treatment with Trinessa (dosage: 1-1.5 Years, T Daily). The following drugs were being taken at the same time: NA. When using Trinessa, the patient experienced the following unwanted symptoms/side effects: Coagulopathy, Blood Urine Present, Cerebrovascular Accident, Off Label Use, Contraindication To Medical TreatmentThe 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 Coagulopathy, may become evident only after a product is in use by the general population.
Trinessa Side Effect Report#7432797-0
Abdominal Pain Upper
This Abdominal Pain Upper side effect was reported by a consumer or non-health professional from United States. A female patient (weight:NA) experienced the following symptoms/conditions: contraception,post coital contraception.The patient was prescribed Trinessa (drug dosage: NA), which was initiated on
Apr 18, 2011. Concurrently used drugs:
  • Plan B One-step (1.5 Milligram;)
.After starting to take Trinessa the consumer reported adverse symptoms, such as: Abdominal Pain UpperThese side effects may potentially be related to Trinessa.
Trinessa Side Effect Report#7429655-4
Pulmonary Embolism, Thrombosis
This is a report of a 30-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: contraception, who was treated with Trinessa (dosage: 1 Tab Qd, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Pulmonary Embolism, Thrombosis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Trinessa treatment in female patients, resulting in Pulmonary Embolism side effect. The patient was hospitalized.
Trinessa Side Effect Report#7409437-X
Depression, Cholelithiasis, Injury, Emotional Distress, Cholecystitis, Nervousness
This report suggests a potential Trinessa Fear Of Death side effect(s) that can have serious consequences. A 21-year-old female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Trinessa (dosage: NA) starting
Dec 01, 2007. After starting Trinessa the patient began experiencing various side effects, including: Depression, Cholelithiasis, Injury, Emotional Distress, Cholecystitis, NervousnessAdditional drugs used concurrently:
  • Yaz (Unk)
Although Trinessa demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Fear Of Death, may still occur.
Trinessa Side Effect Report#7409388-0
Emotional Distress, Cholelithiasis, Injury, Depression, Cholecystitis, Nervousness
This Emotional Distress problem was reported by a health professional from United States. A 21-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Dec 01, 2007 this consumer started treatment with Trinessa (dosage: NA). The following drugs were being taken at the same time:
  • Yaz (Unk)
When using Trinessa, the patient experienced the following unwanted symptoms/side effects: Emotional Distress, Cholelithiasis, Injury, Depression, Cholecystitis, NervousnessAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Emotional Distress, may become evident only after a product is in use by the general population.
Trinessa Side Effect Report#7354534-0
Cholecystitis Chronic, Cholelithiasis, Abdominal Pain Upper, Nausea, Abdominal Pain, Gallbladder Cholesterolosis
This Cholecystitis Chronic side effect was reported by a consumer or non-health professional from United States. A female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Trinessa (drug dosage: Unk), which was initiated on
Nov 10, 2009. Concurrently used drugs:
  • Singulair
  • Ipratropium Bromide
  • Ivega [immunoglobulin Human Normal]
  • Paxil
  • Tetracycline
  • Claritin
  • Wal-itin D Nos (uncodeable ^unclassifiable^)
  • Yaz (Unk)
.After starting to take Trinessa the consumer reported adverse symptoms, such as: Cholecystitis Chronic, Cholelithiasis, Abdominal Pain Upper, Nausea, Abdominal Pain, Gallbladder CholesterolosisThese side effects may potentially be related to Trinessa. The patient was hospitalized.
Trinessa Side Effect Report#7347934-6
Cholelithiasis, Biliary Colic
This is a report of a female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Trinessa (dosage: NA, start time:
Aug 01, 2009), combined with:
  • Midrin
  • Yasmin
  • Yasmin
  • Prevacid
and developed a serious reaction and side effect(s): Cholelithiasis, Biliary Colic after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Trinessa treatment in female patients, resulting in Cholelithiasis side effect. The patient was hospitalized.
Trinessa Side Effect Report#7347478-1
Nephrolithiasis, Abdominal Distension, Abdominal Pain, Gastrooesophageal Reflux Disease, Benign Neoplasm Of Adrenal Gland, Nausea, Abdominal Tenderness, Dyspepsia, Cholelithiasis
This report suggests a potential Trinessa Nephrolithiasis side effect(s) that can have serious consequences. A female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Trinessa (dosage: Unk) starting
Jan 01, 2003. After starting Trinessa the patient began experiencing various side effects, including: Nephrolithiasis, Abdominal Distension, Abdominal Pain, Gastrooesophageal Reflux Disease, Benign Neoplasm Of Adrenal Gland, Nausea, Abdominal Tenderness, Dyspepsia, CholelithiasisAdditional drugs used concurrently:
  • Yasmin (As Used Dose: Unk)
  • Yaz (Unk)
  • Ultram
  • Axid
  • Yasmin (As Used Dose: Unk)
  • Protonix
Although Trinessa demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Nephrolithiasis, may still occur.
Trinessa Side Effect Report#7332656-8
Back Pain, Pelvic Pain
This Back Pain problem was reported by a consumer or non-health professional from United States. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: contraception,post coital contraception. On
Feb 28, 2011 this consumer started treatment with Trinessa (dosage: NA). The following drugs were being taken at the same time:
  • Plan B One-step
When using Trinessa, the patient experienced the following unwanted symptoms/side effects: Back Pain, Pelvic PainAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Back Pain, may become evident only after a product is in use by the general population.
Trinessa Side Effect Report#7329616-X
Menstruation Irregular
This Menstruation Irregular side effect was reported by a consumer or non-health professional from United States. A female patient (weight:NA) experienced the following symptoms/conditions: contraception,post coital contraception.The patient was prescribed Trinessa (drug dosage: NA), which was initiated on
Feb 14, 2011. Concurrently used drugs:
  • Plan B One-step
.After starting to take Trinessa the consumer reported adverse symptoms, such as: Menstruation IrregularThese side effects may potentially be related to Trinessa.
Trinessa Side Effect Report#7314710-X
Abdominal Pain Upper, Diarrhoea, Nausea
This is a report of a 22-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: contraception, who was treated with Trinessa (dosage: NA, start time:
Aug 01, 2010), combined with:
  • Folic Acid
  • Amnesteem
  • Multivitamin
  • Iron
  • Topamax
and developed a serious reaction and side effect(s): Abdominal Pain Upper, Diarrhoea, Nausea after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Trinessa treatment in female patients, resulting in Abdominal Pain Upper side effect.


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The appearance of Trinessa 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 Trinessa Side Effects for Women?

Women Side EffectsReports
Nausea 7
Cholelithiasis 6
Depression 6
Metrorrhagia 6
Pregnancy On Oral Contraceptive 6
Abortion Spontaneous 5
Acne 5
Pulmonary Embolism 5
Abdominal Pain Upper 4
Dizziness 4

What are common Trinessa Side Effects for Men?

Men Side EffectsReports

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.

    Trinessa 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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    Trinessa Safety Alerts, Active Ingredients, Usage Information

    NDC21695-407
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameTriNessa
    NameNorgestimate and Ethinyl Estradiol
    Dosage FormKIT
    Route
    On market since20070817
    LabelerRebel Distributors Corp
    Active Ingredient(s)
    Strength(s)
    Unit(s)
    Pharma Class

    More About Trinessa

    Side Effects reported to FDA: 65

    Trinessa safety alerts: No

    Reported deaths: 2

    Reported hospitalizations: 12

    Latest Trinessa clinical trials