What the label lists and what reports show
Norethindrone side effects
Norethindrone's FDA label: “Menstrual irregularity is the most frequently reported side effect.” FAERS holds 5,466 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (460 reports).
- Generic listed
Check it at the source: the norethindrone FDA label on DailyMed (effective January 31, 2026, Glenmark Pharmaceuticals Inc., USA); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMenstrual irregularity is the most frequently reported side effect.
From the label: adverse reactions, continuedAdverse reactions reported with the use of POPs include: • Menstrual irregularity is the most frequently reported side effect. • Frequent and irregular bleeding are common, while long duration of bleeding episodes and amenorrhea are less likely. • Headache, breast tenderness, nausea, and dizziness are increased among progestin-only oral contraceptive users in some studies. • Androgenic side effects such as acne, hirsutism, and weight gain occur rarely. The following adverse reactions were also reported in clinical trials or during post-marketing experience: Gastrointestinal Disorders: vomiting, abdominal pain; General Disorders and Administration Site Conditions: fatigue, edema; Psychiatric Disorders: depression, nervousness; Musculoskeletal and Connective Tissue Disorders: pain in extremity; Reproductive System and Breast Disorders: genital discharge; breast pain, menstruation delayed, suppressed lactation, vaginal hemorrhage, menorrhagia, withdrawal bleed when product is stopped; Immune System Disorders: anaphylactic/anaphylactoid reaction, hypersensitivity; Hepatobiliary Disorders: hepatitis, jaundice cholestatic; Skin and Subcutaneous Tissue Disorders: alopecia, rash, rash pruritic.
Source: FDA drug label, Glenmark Pharmaceuticals Inc., USA, effective January 31, 2026 (SPL set 0d2f8fea-3675-40d2-afd9-9fcb148dbd4b), via openFDA; the full label on DailyMed
What do FAERS reports show?
5,466 reports list norethindrone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 83 are coded as a death and 971 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 6 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Norethindrone: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions