01What should I tell the clinician on day one?
Name sexual changes, breast changes, and mood changes when they start. The Year 1 table is the common list. The postmarketing list is the persistence and mood list. Do not double the 1 mg tablet to 'push through' a sexual change. The dose page stays one tablet once daily. Stopping or staying on is a chart decision, and stopping also reverses the hair effect within 12 months on the stay-on ask.
02Is priapism the first listed reaction?
No. The hair label leads with decreased libido, erectile dysfunction, and ejaculation disorder. Priapism is not the Year 1 table. A painful erection that will not go down is still an emergency anywhere, but it is not the lead reaction on the hair label. Hypersensitivity after approval includes rash, pruritus, urticaria, and angioedema of lips, tongue, throat, or face. Those allergy reports sit beside the sexual list, not above it. Year 1 still opens with libido 1.8 percent versus 1.3, erection trouble 1.3 versus 0.7, and ejaculation disorder 1.2 versus 0.7.
03What percentages sat in Year 1?
Table 1 is Year 1, drug-related, in male pattern hair loss. Propecia N=945, placebo N=934. Decreased libido 1.8 percent versus 1.3. Erectile dysfunction 1.3 percent versus 0.7. Ejaculation disorder 1.2 percent versus 0.7, with decreased volume of ejaculate 0.8 percent versus 0.4. Discontinuation due to drug-related sexual experiences was 1.2 percent versus 0.9.
During treatment, 36 of 945 men (3.8 percent) reported one or more of those sexual experiences, compared with 20 of 934 (2.1 percent) on placebo. Resolution occurred in men who discontinued because of these effects and in most of those who continued therapy.
04Did those sexual reports stay at the same rate every year?
The incidence of each of those Year 1 sexual experiences decreased to 0.3 percent or less by the fifth year of treatment with Propecia. That is a later-year incidence, not a promise that a first-year symptom vanishes on a calendar. In healthy men on 1 mg, a median decrease in ejaculate volume of 0.3 mL (11 percent) versus 0.2 mL (8 percent) on placebo was seen after 48 weeks. A sexual function questionnaire in the vertex trials found differences favoring placebo at month 12 in sexual interest, erections, and perception of problems. Overall satisfaction with sex life did not differ.
05What about breast tenderness or enlargement?
In the Propecia clinical studies, the incidences of breast tenderness and enlargement, hypersensitivity reactions, and testicular pain were not different from placebo. After approval, breast tenderness and enlargement were reported, and male breast cancer is listed among neoplasms of uncertain frequency. Physicians should tell patients to report breast lumps, pain, or nipple discharge promptly. The relationship between long-term finasteride use and male breast neoplasia is currently unknown. That unknown is why the lump gets a look, not a wait. Report pain or nipple discharge the same week you notice it, not at the next hair visit only.
06What did postmarketing reports add after the tablet stopped?
Postmarketing reports include sexual dysfunction that continued after discontinuation: erectile dysfunction, libido disorders, ejaculation disorders, and orgasm disorders. Male infertility and poor seminal quality were reported; normalization or improvement of seminal quality has been reported after stopping. Depression, suicidal ideation, and behavior are listed under nervous system and psychiatric reports. Those reports come from a population of uncertain size, so frequency is not pinned down. Testicular pain and hematospermia are also on that after-approval reproductive list. Tell the clinician when a sexual change does not leave after the last tablet.