Deviry Side effects

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What are the possible side effects of Deviry?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Side effects of Deviry in details

A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
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Clinical Trials Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In the 2 clinical trials with Deviry, over 3900 women, who were treated for up to 7 years, reported the following adverse reactions, which may or may not be related to the use of Deviry. The population studied ranges in from 15-51 years, of which 46% were White, 50% non-White and 4.9% Unknown race. The patients received Depo-Provera 150 mg every 3-months (90 days). The median study duration was 13 months with a range of 1-84 months. Fifty eight percent (58%) of patients remained in the study after 13 months and 34% after 24 months.

Adverse reactions that were reported by >5% of subjects are: Body as a Whole*: Headache (16.5%), abdominal pain/discomfort (11.2%).

Metabolic/Nutritional*: Increased weight >10 lbs at 24 months (37.7%).

Nervous*: Nervousness (10.8%), dizziness (5.6%), decreased libido (5.5%).

Urogenital*: Menstrual irregularities [bleeding (57.3% at 12 months, 32.1% at 24 months), amenorrhea (55% at 12 months, 68% at 24 months)].

Adverse reactions that were reported between 1% and 5% of subjects are: Body as a Whole*: Asthenia/fatigue (4.2%), backache (2.2%), dysmenorrhea (1.7%), hot flashes (1%).

Digestive*: Nausea (3.3%), bloating (2.3%).

Metabolic/Nutritional*: Edema (2.2%).

Musculoskeletal*: Leg cramps (3.7%), arthralgia (1%).

Nervous*: Depression (1.5%), insomnia (1%).

Skin and Appendages*: Acne (1.2%), no hair growth/alopecia (1.1%), rash (1.1%).

Urogenital*: Leukorrhea (2.9%), breast pain (2.8%), vaginitis (1.2%).

*Body system represented from COSTART medical dictionary.

Adverse reactions leading to study discontinuation in ≥2% subjects are bleeding (8.2%), amenorrhea (2.1%), weight gain (2%).

Post-Marketing Experience: The following adverse reactions have been identified during post approval use of Deviry.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

There have been cases of osteoporosis including osteoporotic fractures reported post-marketing in patients taking Deviry.

Adverse reactions reported during post-marketing experience are: Body as Whole*: Chest pain, Allergic reactions, fever, injection site pain, chills, axillary swelling.

Cardiovascular*: Syncope, tachycardia, thrombophlebitis, deep vein thrombosis, pulmonary embolus, varicose veins.

Digestive*: Appetite changes, gastrointestinal disturbances, jaundice, excessive thirst, rectal bleeding.

Hematologic and Lymphatic*: Anemia, blood dyscrasia.

Musculoskeletal*: Osteoporosis.

Nervous*: Paralysis, facial palsy, paresthesia, drowsiness.

Respiratory*: Dyspnea and asthma, hoarseness.

Skin and Appendages*: Hirsutism, excessive sweating and body odor, dry skin, scleroderma.

Urogenital*: Cervical and breast cancer, lack of return to fertility, unexpected pregnancy, prevention of lactation, changes in breast size, breast lumps or nipple bleeding, galactorrhea, melasma, chloasma, increased libido, uterine hyperplasia, genitourinary infections, vaginal cysts, dyspareunia.

What is the most important information I should know about Deviry?

Deviry contraindications

Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.
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Known hypersensitivity to Deviry or any other ingredients of Deviry.

Known or suspected pregnancy or as a diagnostic test for pregnancy. Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease. Known or suspected malignancy of breast. Significant liver disease. Undiagnosed vaginal bleeding.

Deviry should not be used as a long-term birth control method (ie, >2 years) unless other birth control methods are considered inadequate.

Use in pregnancy: Deviry should not be administered during pregnancy.

References

  1. DailyMed. "MEDROXYPROGESTERONE ACETATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. DTP/NCI. "Medroxyprogesterone acetate: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
  3. European Chemicals Agency - ECHA. "Medroxyprogesterone acetate: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Deviry are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Deviry. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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