Side effects of Mini-Pill in details
Throughout this section, adverse reactions are presented. Adverse reactions are adverse events that were considered to be reasonably associated with the use of Mini-Pill based on the comprehensive assessment of the available adverse event information. A causal relationship with Mini-Pill usually cannot be reliably established in individual cases. Further, because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Clinical Trial Data: The safety of Mini-Pill was evaluated in 3099 subjects in 2 clinical trials. Of these, 2925 subjects participated in a clinical trial of Mini-Pill 0.35 mg administered daily and 174 subjects participated in a clinical trial of Mini-Pill 0.35 mg/day administered on 21 days/cycle. Adverse reactions reported for ≥1% of Mini-Pill-treated subjects are shown in the table.
Adverse reactions reported by <1% of Mini-Pill-treated subjects (N=3099) in the previously stated clinical trials are as follows: Psychiatric Disorders: Depression, nervousness. Gastrointestinal Disorders: Gastrointestinal disorder. Skin and Subcutaneous Tissue Disorders: Acne, hirsutism. Musculoskeletal and Connective Tissue Disorders: Pain in extremity. Reproductive System and Breast Disorders: Genital discharge. General Disorders and Administration Site Conditions: Edema.
Post-Marketing Data: Adverse reactions 1st identified during post-marketing experience with Mini-Pill are included as follows. The frequencies are provided according to the following convention: Very common ≥1/10; common ≥1/100 and <1/10; uncommon ≥1/1000 and <1/100; rare ≥1/10,000, <1/1000; very rare <1/10,000, including isolated reports; unknown (cannot be estimated from the available data).
Adverse reactions are presented by frequency category based on spontaneous reporting rates.
Immune System Disorders: Very rare: Anaphylactic/anaphylactoid reaction, hypersensitivity.
Gastrointestinal Disorders: Very rare: Abdominal pain.
Hepatobiliary Disorders: Very rare: Hepatitis, cholestatic jaundice.
Skin and Subcutaneous Tissue Disorders: Very rare: Alopecia, rash, pruritic rash.
Pregnancy, Puerperium and Perinatal Conditions: Very rare: Ectopic pregnancy.
Reproductive System and Breast Disorders: Very rare: Breast pain, delayed menstruation, irregular menstruation, ovarian cyst, suppressed lactation, vaginal hemorrhage, menorrhagia, withdrawal bleeding when Mini-Pill is stopped.
Mini-Pill contraindications
Hypersensitivity to any component of Mini-Pill. Known or suspected carcinoma of the breast; benign or malignant liver tumor; acute or chronic hepatocellular disease with abnormal liver function; undiagnosed abnormal genital bleeding.
Use in pregnancy: Mini-Pill is contraindicated during pregnancy.
Many studies have found no effects on fetal development associated with long-term use of contraceptive doses of oral progestins. The few studies of infant growth and development that have been conducted have not demonstrated significant adverse effects. Suspected pregnancy should be ruled out before initiating any hormonal contraceptive use.
References
- DailyMed. "NORETHINDRONE: 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).
- European Chemicals Agency - ECHA. "Norethisterone: 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).
- HSDB. "NORETHINDRONE". https://toxnet.nlm.nih.gov/cgi-bin/s... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Mini-Pill 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 Mini-Pill. 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
Consumer reported side effects
No survey data has been collected yetConsumer reviews
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Information checked by Dr. Sachin Kumar, MD Pharmacology
