A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Parlodel Side Effects, and Drug Interactions - Bromocriptine
Parlodel Side Effects, and Drug Interactions - Bromocriptine
SIDE EFFECTS
Hyperprolactinemic Indications
The incidence of adverse effects is quite high (69%) but these are generally
mild to moderate in degree. Therapy was discontinued in approximately
5% of patients because of adverse effects. These in decreasing order of
frequency are: nausea (49%), headache (19%), dizziness (17%), fatigue
(7%), lightheadedness (5%), vomiting (5%), abdominal cramps (4%), nasal
congestion (3%), constipation (3%), diarrhea (3%) and drowsiness (3%).
A slight hypotensive effect may accompany bromocriptine mesylate treatment.
The occurrence of adverse reactions may be lessened by temporarily reducing
dosage to 1,2 tablet 2 or 3 times daily. A few cases of cerebrospinal
fluid rhinorrhea have been reported in patients receiving bromocriptine
mesylate for treatment of large prolactinomas. This has occurred rarely,
usually only in patients who have received previous transsphenoidal surgery,
pituitary radiation, or both, and who were receiving bromocriptine mesylate
for tumor recurrence. It may also occur in previously untreated patients
whose tumor extends into the sphenoid sinus.
Acromegaly
The most frequent adverse reactions encountered in acromegalic patients
treated with bromocriptine mesylate were: nausea (18%), constipation (14%),
postural/orthostatic hypotension (6%), anorexia (4%), dry mouth/nasal
stuffiness (4%), indigestion/dyspepsia (4%), digital vasospasm (3%), drowsiness/tiredness
(3%) and vomiting (2%).
Less frequent adverse reactions (less than 2%) were: gastrointestinal
bleeding, dizziness, exacerbation of Raynaud’s Syndrome, headache and
syncope. Rarely (less than 1 %) hair loss, alcohol potentiation, faintness,
lightheadedness, arrhythmia, ventricular tachycardia, decreased sleep
requirement, visual hallucinations, lassitude, shortness of breath, bradycardia,
vertigo, paresthesia, sluggishness, vasovagal attack, delusional psychosis,
paranoia, insomnia, heavy headedness, reduced tolerance to cold, tingling
of ears, facial pallor and muscle cramps have been reported.
Parkinson’s Disease
In clinical trials in which bromocriptine was administered with concomitant
reduction in the dose of levodopa/carbidopa, the most common newly appearing
adverse reactions were: nausea, abnormal involuntary movements, hallucinations,
confusion, “on-off” phenomenon, dizziness, drowsiness, faintness/fainting,
vomiting, asthenia, abdominal discomfort, visual disturbance, ataxia,
insomnia, depression, hypotension, shortness of breath, constipation,
and vertigo.
Less common adverse reactions which may be encountered include: anorexia,
anxiety, blepharospasm, dry mouth, dysphagia, edema of the feet and ankles,
erythromelalgia, epileptiform seizure, fatigue, headache, lethargy, mottling
of skin, nasal stuffiness, nervousness, nightmares, paresthesia, skin
rash, urinary frequency, urinary incontinence, urinary retention, and
rarely, signs and symptoms of ergotism such as tingling of fingers, cold
feet, numbness, muscle cramps of feet and legs or exacerbation of Raynaud’s
Syndrome.
Abnormalities in laboratory tests may include elevations in blood urea
nitrogen, SGOT, SGPT, GGPT, CPK, alkaline phosphatase and uric acid, which
are usually transient and not of clinical significance.
Adverse Events Observed in Other Conditions
Postpartum Patients
In postpartum studies with bromocriptine mesylate 23 percent of postpartum
patients treated had at least 1 side effect, but they were generally mild
to moderate in degree. Therapy was discontinued in approximately 3% of
patients. The most frequently occurring adverse reactions were: headache
(10%), dizziness (8%), nausea (7%), vomiting (3%), fatigue (1.0%), syncope
(0.7%), diarrhea (0.4%) and cramps (0.4%). Decreases in blood pressure
(³20
mm Hg systolic and ³10
mm Hg diastolic) occurred in 28% of patients at least once during the
first 3 postpartum days; these were usually of a transient nature. Reports
of fainting in the puerperium may possibly be related to this effect.
In postmarketing experience in the U.S. serious adverse reactions reported
include 72 cases of seizures (including 4 cases of status epilepticus),
30 cases of stroke, and 9 cases of myocardial infarction among postpartum
patients. Seizure cases were not necessarily accompanied by the development
of hypertension. An unremitting and often progressively severe headache,
sometimes accompanied by visual disturbance, often preceded by hours to
days many cases of seizure and/or stroke. Most patients had shown no evidence
of any of the hypertensive disorders of pregnancy including eclampsia.
preeclampsia or pregnancy induced hypertension. One stroke case was associated
with sagittal sinus thrombosis, and another was associated with cerebral
and cerebellar vasculitis. One case of myocardial infarction was associated
with unexplained disseminated intravascular coagulation and a second occurred
in conjunction with use of another ergot alkaloid. The relationship of
these adverse reactions to bromocriptine mesylate administration has not
been established.
DRUG INTERACTIONS
The risk of using bromocriptine mesylate in combination with other drugs
has not been systematically evaluated, but alcohol may potentiate the
side effects of bromocriptine mesylate. Bromocriptine mesylate may interact
with dopamine antagonists, butyrophenones, and certain other agents. Compounds
in these categories result in a decreased efficacy of bromocriptine mesylate:
phenothiazines, haloperidol, metoclopramide, pimozide. Concomitant use
of bromocriptine mesylate with other ergot alkaloids is not recommended.
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