Neofollin Side effects

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What are the possible side effects of Neofollin?

Neofollin increases the risk of developing a condition (endometrial hyperplasia) that may lead to cancer of the lining of the uterus. Taking progestins, another hormone drug, while using Neofollin lowers the risk of developing this condition. Therefore, if your uterus has not been removed, your doctor may prescribe a progestin for you to take together while using Neofollin. Visit your doctor regularly and report any unusual vaginal bleeding right away.

Treatment with Neofollin long-term may increase the risk of stroke. Because of this risk, you should contact your doctor or healthcare provider to discuss your individual risks and benefits before taking Neofollin long-term. You should also talk to your doctor or healthcare provider on a regular basis (for example, every 3-6 months) about whether you should continue this treatment.

If you experience any of the following serious side effects, stop using Neofollin and seek emergency medical attention:

Other, less serious side effects may be more likely to occur. Continue to use Neofollin and talk to your doctor if you experience

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Side effects of Neofollin 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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See WARNINGS and Boxed Warning regarding the potential adverse effects on the fetus, the induction of malignant neoplasms, gallbladder disease, cardiovascular disease, elevated blood pressure, and hypercalcemia.

Skin irritation: In controlled clinical studies with Neofollin (Neofollin transdermal), the most commonly reported adverse events were topical reactions of erythema and/or pruritus at the application site. In general these reactions caused patients little or no discomfort, and led to premature discontinuation of treatment in 0.9% (3/317) of patients in these trials. The rate of application site reactions, based on 8,135 applications of the 0.025, 0.05, and 0.1 Neofollin (Neofollin transdermal) systems in these trials was 6.1 per 100 applications (4.9, 5.4, 10.7 for the 3 Neofollin (Neofollin transdermal) doses respectively) compared to 6.2 in the placebo treated patients (2,014 applications).

In a placebo-controlled trial of Neofollin (Neofollin transdermal) 0.025, 0.05, and 0.1 conducted in 196 patients in the US, the adverse events reported by at least 5% of patients in 1 or more of the treatment groups are shown in Table 5.

Table 5: Incidence of Adverse Events >5% in a Placebo-Controlled Study of Neofollin Data Are Expressed as % of Treatment Group

Placebo

Neofollin

Neofollin

Neofollin

Adverse Event

0.025 mg/day

0.05 mg/day

0.1 mg/day

(N=54)

(N=48)

(N=47)

(N=47)

Breast Pain

3.7

25.0

44.7

46.8

Headache

22.2

18.8

8.5

6.4

Infection

7.4

10.4

10.6

8.5

Injury Accident

3.7

10.4

4.3

2.1

Anxiety

0

8.3

2.1

0

Emotional Lability

1.9

8.3

2.1

6.4

Arthralgia

1.9

6.3

2.1

4.3

Flu Syndrome

7.4

6.3

6.4

8.5

Joint Disorder

0

6.3

0

0

Pruritus

1.9

6.3

12.8

0

Rhinitis

1.9

6.3

4.3

4.3

Abdominal Pain

9.3

4.2

10.6

2.1

General Edema

1.9

4.2

6.4

6.4

Monilia Vagina

5.6

4.2

8.5

4.3

Nausea

1.9

4.2

10.6

8.5

Peripheral Edema

0

4.2

2.1

6.4

Sinusitis

7.4

4.2

2.1

4.3

Asthenia

1.9

2.1

10.6

6.4

Back Pain

3.7

2.1

2.1

6.4

Diarrhea

1.9

2.1

8.5

0

Dysmenorrhea

0

2.1

2.1

6.4

Enlarged Abdomen

0

2.1

2.1

6.4

Enlarged Breast

0

2.1

2.1

8.5

Rash

5.6

2.1

4.3

2.1

Anemia

0

0

6.4

4.3

Gastroenteritis

1.9

0

0

6.4

Hyperlipemia

5.6

0

0

2.1

Leukorrhea

0

0

12.8

0

Paresthesia

1.9

0

6.4

0

Urogenital Adverse Events : In the US placebo-controlled study, 72 patients were included who had intact uteri. As expected, after 12-13 weeks of continuous unopposed therapy, findings of endometrial hyperplasia (diagnosed either by endometrial biopsy and/or ultrasonography) were increased with increasing doses of Neofollin (placebo: 0/18 patients; Neofollin (Neofollin transdermal) 0.025: 1/14 (7.1%); Neofollin (Neofollin transdermal) 0.05: 12/22 (54.5%); Neofollin (Neofollin transdermal) 0.1: 10/18 (55.6%). In the 86 patients who had not previously undergone a total hysterectomy, vaginal bleeding was also increased with increasing doses of Neofollin [placebo: 2/21 patients (9.5%); Neofollin (Neofollin transdermal) 0.025: 6/19 (31.6%); Neofollin (Neofollin transdermal) 0.05: 14/25 (56.0%); Neofollin (Neofollin transdermal) 0.1: 12/21 (57.1%)].

In 2 long-term studies involving a total of 488 patients treated for a mean duration of 618 days and up to 3.5 years, the nature and incidence of adverse events did not change with prolonged duration of treatment.

The following additional adverse reactions have been reported with estrogen therapy:

1. Genitourinary System. Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding, spotting; increase in size of uterine leiomyomata; vaginal candidiasis; change in amount of cervical secretion.

2. Breasts. Tenderness, enlargement.

3. Gastrointestinal. Nausea, vomiting; abdominal cramps, bloating; cholestatic jaundice; gallbladder disease.

4. Skin. Chloasma or melasma that may persist when drug is discontinued; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism.

5. Eyes. Steepening of corneal curvature: intolerance to contact lenses.

6. Central Nervous System. Headache, migraine, dizziness; mental depression; chorea.

7. Miscellaneous. Increase or decrease in weight; reduced carbohydrate tolerance; aggravation of porphyria; edema; changes in libido.

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

Neofollin 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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Neofollin can harm an unborn baby or cause birth defects. Do not use if you are pregnant.

You should not use this medication if you have any of the following conditions: liver disease, a bleeding disorder, unusual vaginal bleeding, a history of breast or uterine cancer, or if you have ever had a heart attack, stroke, or a blood clot.

Neofollin may increase your risk of developing a condition that may lead to uterine cancer. Your doctor may prescribe a progestin while you are using Neofollin, to help lower this risk. Report any unusual vaginal bleeding right away.

Long-term use of Neofollin may increase your risk of breast cancer, heart attack, stroke, or blood clot. Talk with your doctor about your individual risks before using Neofollin transdermal long term.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using Neofollin transdermal.

Neofollin transdermal should not be used to prevent heart disease, stroke, or dementia, because this medicine may actually increase your risk of developing these conditions.


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References

  1. DailyMed. "ESTRADIOL HEMIHYDRATE: 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. "estradiol: 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. "Estradiol: 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 Neofollin 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 Neofollin. 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.

User reports

1 consumer reported side effects

Did you experience side effects while taking Neofollin drug?
According to the report by ndrugs.com, the below mentioned statistics discuss the number of people who experienced side effects after taking Neofollin drug. Every drug produces at least minor unwanted effects, which we call side effects. The side effects can be bothersome, or they can be minor so patients do not know they are experiencing them. The side effects of the drug depend on the individual, severity of disease, symptom, and associated conditions in the patient. The most deciding factor is the drug dosage. The higher the dosage, the higher the therapeutic result, and the more side effects. Every patient need not have the same intensity of side effect. When the side effects are greater, immediately consult your health care provider.
Users%
No side effects1
100.0%


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