J Obstet Gynecol Neonatal Nurs. 1991 Jul-Aug;20(4):321-7.
Clomiphene-induced mood swings.
Blenner JL.
School of Nursing, San Diego State University, CA 92182-0254.
A study of couples' perceptions of infertility treatment with clomiphene (clomiphene citrate) revealed mood swings in 9 out of 14 women using the drug. This paper describes the mood swings and the responses of women and their spouses. Three phases of mood swing response emerged from the data: lacking awareness of the relation of the mood swings to the drug; gaining awareness of that relation; and managing the mood swings. The results of the study provide important information for nurses counseling couples who are experiencing clomiphene-induced mood swings.
----------------------------------------------------------------
Am J Psychiatry. 1997 Aug;154(8):1169-70.
Clomiphene-induced psychosis.
Oyffe I, Lerner A, Isaacs G, Harel Y, Sigal M.
----------------------------------------------------------------
Can Med Assoc J. 1982 Jan 15;126(2):118.
Clomiphene citrate as a possible cause of psychosis.
Cashman FE, Sheppard R.
---------------------------------------------------------------------
Clomiphene citrate as a possible cause of a psychotic reaction during infertility treatment
F Siedentopf, B Horstkamp, G Stief and H Kentenich
Department of Obstetrics and Gynecology, DRK-Kliniken Westend, Berlin, Germany.
Secondary side-effects often occur in women undergoing hormonal stimulation treatment with clomiphene citrate. In general 10.4% of women experience hot flushing, 5.5% have complaints caused by enlargement of the ovaries and 3.5% experience central nervous symptoms (nervousness, sleeplessness, headaches, visual disturbances, vertigo). During ovarian stimulation with clomiphene citrate for in-vitro fertilization, a 32 year old patient developed psychotic symptoms, commencing 3 days after initiation of treatment. Hospitalization in the psychiatric ward became necessary when severe formal and rational thought disturbances arose together with perceptory and sensory delusions. Under neuroleptic treatment the symptoms improved. Nevertheless, follow-up psychiatric care on an outpatient basis was deemed necessary. The infertility treatment was continued with human menopausal gonadotrophin stimulation. Psychiatric instability occurred neither at this point nor during the 2 year follow-up observation period. Both an exogenous psychosis (ICD F23.9) as well as the exacerbation of an endogenous psychosis (ICD F29) may be considered for the differential diagnosis. The stimulation with clomiphene citrate in connection with the physical and psychic stress of the infertility therapy can be regarded as the trigger factor. For patients with evidence of psychiatric illness in their case history, ovulation- inducing substances such as clomiphene citrate should be implemented with particular care.
---------------------------------------------------------------------------
From the FDA
SIDE EFFECTS
Clinical Events
Trial Adverse: Clomiphene citrate Tablets USP at recommended dosages, is generally well tolerated. Adverse reactions usually have been mild and transient and most have disappeared promptly after treatment has been discontinued.
Includes 495 patients whose reports may have been duplicated in the event totals and could not be distinguished as such. Also, excludes 47 patients who did not report symptom data.
The following adverse events have been reported in fewer than 1% of patients in clinical trails: Acute abdomen, appetite increase, constipation, dermatitis or rash, depression, diarrhea, dizziness, fatigue, hair loss/dry hair, increased urinary frequency/volume, insomnia, light-headedness, nervous tension, vaginal dryness, vertigo, weight gain/loss.
Patients on prolonged clomiphene citrate tablets USP therapy may show elevated serum levels of desmoschol. This is most likely due to a direct interference with cholesterols synthesis. However, the serum sterols in patients receiving the recommended dose of clomiphene citrate tablets USP are not significantly altered. Ovarian cancer has been infrequently reported in patients who have received fertility drugs. Infertility is a primary risk factor for ovarian cancer; however, epidemiology data suggest that prolonged use of clomiphene citrate tablets USP may increase the risk of a borderline or invasive ovarian tumor.
Postmarketing Adverse Events
The following adverse experiences were reported spontaneously with clomiphene citrate tablets USP. The cause and effect relationship of the listed events to the administration of clomiphene citrate tablets USP is not known.
Dermatologic: Acne, allergic reaction, erythema, erythema multiforme, erythema nodosum, hypertrichosis, pruritus.
Central Nervous System: Migraine headache, paresthesia, seizure, stroke, syncope.
Psychiatric: Anxiety irritability, mood changes, psychosis.
Clomiphene-induced mood swings.
Blenner JL.
School of Nursing, San Diego State University, CA 92182-0254.
A study of couples' perceptions of infertility treatment with clomiphene (clomiphene citrate) revealed mood swings in 9 out of 14 women using the drug. This paper describes the mood swings and the responses of women and their spouses. Three phases of mood swing response emerged from the data: lacking awareness of the relation of the mood swings to the drug; gaining awareness of that relation; and managing the mood swings. The results of the study provide important information for nurses counseling couples who are experiencing clomiphene-induced mood swings.
----------------------------------------------------------------
Am J Psychiatry. 1997 Aug;154(8):1169-70.
Clomiphene-induced psychosis.
Oyffe I, Lerner A, Isaacs G, Harel Y, Sigal M.
----------------------------------------------------------------
Can Med Assoc J. 1982 Jan 15;126(2):118.
Clomiphene citrate as a possible cause of psychosis.
Cashman FE, Sheppard R.
---------------------------------------------------------------------
Clomiphene citrate as a possible cause of a psychotic reaction during infertility treatment
F Siedentopf, B Horstkamp, G Stief and H Kentenich
Department of Obstetrics and Gynecology, DRK-Kliniken Westend, Berlin, Germany.
Secondary side-effects often occur in women undergoing hormonal stimulation treatment with clomiphene citrate. In general 10.4% of women experience hot flushing, 5.5% have complaints caused by enlargement of the ovaries and 3.5% experience central nervous symptoms (nervousness, sleeplessness, headaches, visual disturbances, vertigo). During ovarian stimulation with clomiphene citrate for in-vitro fertilization, a 32 year old patient developed psychotic symptoms, commencing 3 days after initiation of treatment. Hospitalization in the psychiatric ward became necessary when severe formal and rational thought disturbances arose together with perceptory and sensory delusions. Under neuroleptic treatment the symptoms improved. Nevertheless, follow-up psychiatric care on an outpatient basis was deemed necessary. The infertility treatment was continued with human menopausal gonadotrophin stimulation. Psychiatric instability occurred neither at this point nor during the 2 year follow-up observation period. Both an exogenous psychosis (ICD F23.9) as well as the exacerbation of an endogenous psychosis (ICD F29) may be considered for the differential diagnosis. The stimulation with clomiphene citrate in connection with the physical and psychic stress of the infertility therapy can be regarded as the trigger factor. For patients with evidence of psychiatric illness in their case history, ovulation- inducing substances such as clomiphene citrate should be implemented with particular care.
---------------------------------------------------------------------------
From the FDA
SIDE EFFECTS
Clinical Events
Trial Adverse: Clomiphene citrate Tablets USP at recommended dosages, is generally well tolerated. Adverse reactions usually have been mild and transient and most have disappeared promptly after treatment has been discontinued.
Includes 495 patients whose reports may have been duplicated in the event totals and could not be distinguished as such. Also, excludes 47 patients who did not report symptom data.
The following adverse events have been reported in fewer than 1% of patients in clinical trails: Acute abdomen, appetite increase, constipation, dermatitis or rash, depression, diarrhea, dizziness, fatigue, hair loss/dry hair, increased urinary frequency/volume, insomnia, light-headedness, nervous tension, vaginal dryness, vertigo, weight gain/loss.
Patients on prolonged clomiphene citrate tablets USP therapy may show elevated serum levels of desmoschol. This is most likely due to a direct interference with cholesterols synthesis. However, the serum sterols in patients receiving the recommended dose of clomiphene citrate tablets USP are not significantly altered. Ovarian cancer has been infrequently reported in patients who have received fertility drugs. Infertility is a primary risk factor for ovarian cancer; however, epidemiology data suggest that prolonged use of clomiphene citrate tablets USP may increase the risk of a borderline or invasive ovarian tumor.
Postmarketing Adverse Events
The following adverse experiences were reported spontaneously with clomiphene citrate tablets USP. The cause and effect relationship of the listed events to the administration of clomiphene citrate tablets USP is not known.
Dermatologic: Acne, allergic reaction, erythema, erythema multiforme, erythema nodosum, hypertrichosis, pruritus.
Central Nervous System: Migraine headache, paresthesia, seizure, stroke, syncope.
Psychiatric: Anxiety irritability, mood changes, psychosis.