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
Imitrex Side Effects, and Drug Interactions - Sumatriptan Succinate (intranasal)
Imitrex Side Effects, and Drug Interactions - Sumatriptan Succinate (intranasal)
SIDE EFFECTS
Serious cardiac events,
including some that have been fatal, have occurred following the use of
sumatriptan succinate injection
or tablets. These events are extremely rare and most have been reported
in patients with risk factors
predictive of CAD. Events reported have included coronary artery vasospasm,
transient myocardial
ischemia, myocardial infarction,
ventricular tachycardia, and ventricular
fibrillation (see CONTRAINDICATIONS,
WARNINGS, and PRECAUTIONS).
Significant hypertensive
episodes, including hypertensive
crises, have been reported on rare occasions in patients with or without
a history of hypertension (see WARNINGS).
Incidence in Controlled Clinical Trials
Among 3653 patients treated with sumatriptan nasal
spray in active- and placebo-controlled clinical
trials, less than 0.4% of patients withdrew for reasons related to adverse
events. TABLE 8 lists adverse events that occurred in worldwide placebo-controlled
trials in 3419 migraineurs. The events cited reflect experience
gained under closely monitored conditions of clinical
trials in a highly selected patient
population. In actual clinical
practice or other clinical
trials, these frequency estimates may not apply, as the conditions of
use, reporting behavior, and the kinds of patients treated may differ.
Only events that occurred at a frequency of 1% or more in the sumatriptan
nasal spray 20-mg treatment
group and were more frequent
in that group than in the placebo
group are included in TABLE
8 .
| TABLE 8 Treatment-Emergent Adverse Events
Reported by at Least 1% of Patients in Controlled Migraine Trials |
| Adverse Event Type |
Percent of Patients Reporting |
| Placebo |
Sumatriptan |
| 5 mg |
10 mg |
20 mg |
| (n=704) |
(n=496) |
(n=1007) |
(n=1212) |
| Atypical Sensations |
| Burning sensation |
0.1% |
0.4% |
0.6% |
1.4% |
| Ear, Nose, and Throat |
| Disorder/discomfort of nasal
cavity/sinuses |
2.4% |
2.8% |
2.5% |
3.8% |
| Throat discomfort |
0.9% |
0.8% |
1.8% |
2.4% |
| Gastrointestinal |
| Nausea and/or vomiting |
11.3% |
12.2% |
11.0% |
13.5% |
| Neurological |
| Bad/unusual taste |
1.7% |
13.5% |
19.3% |
24.5% |
| Dizziness/vertigo |
0.9% |
1.0% |
1.7% |
1.4% |
Phonophobia also occurred in more than 1% of patients but was more frequent
on placebo.
Sumatriptan nasal spray is
generally well tolerated. Across all doses, most adverse reactions were
mild and transient and did
not lead to long-lasting effects.
The incidence of adverse
events in controlled clinical
trials was not affected by gender, weight, or age
of the patients; use of prophylactic medications; or presence of aura.
There were insufficient data to assess the impact of race
on the incidence of adverse
events.
Other Events Observed in Association With the Administration of Sumatriptan
Nasal Spray
In the paragraphs that follow, the frequencies of less commonly reported
adverse clinical events are
presented. Because the reports include events observed in open
and uncontrolled studies, the role
of sumatriptan nasal spray in their causation cannot be reliably determined.
Furthermore, variability associated with adverse event reporting, the
terminology used to describe the adverse events, etc., limit
the value of the quantitative
frequency estimates provided. Event frequencies are calculated as the
number of patients who used
sumatriptan nasal spray (5,
10, or 20 mg in controlled and uncontrolled trials) and reported an event
divided by the total number
of patients (n=3711) exposed to sumatriptan nasal
spray. All reported events are included except those already listed in
TABLE 8, those too general to be informative, and those not reasonably
associated with the use of the drug. Events are further classified within
body system categories and
enumerated in order of decreasing
frequency using the following definitions: Infrequent Adverse events
are those occurring in 1/100 to 1/1000 patients and Rare Adverse
events are those occurring in fewer than 1/1000 patients.
Atypical Sensations: Infrequent: Tingling, warm/hot
sensation, numbness, pressure
sensation, feeling strange,
feeling of heaviness, feeling
of tightness, paresthesia, cold
sensation, and tight feeling
in head. Rare: Dysesthesia and prickling sensation.
Cardiovascular: Infrequent: Flushing and hypertension
(See WARNINGS), palpitations,
tachycardia, changes in ECG, and arrhythmia
(See WARNINGS and PRECAUTIONS).
Rare: Abdominal aortic
aneurysm, hypotension, bradycardia, pallor, and phlebitis.
Chest Symptoms: Infrequent: Chest tightness, chest
discomfort, and chest pressure/heaviness
(See PRECAUTIONS, General).
Ear, Nose, and Throat: Infrequent: Disturbance of
hearing and ear
infection. Rare: otalgia
and Meniere's disease.
Endocrine and Metabolic: Infrequent: Thirst. Rare:
Galactorrhea, hypothyroidism, and weight
loss.
Eye: Infrequent: Irritation of eyes and visual disturbance.
Gastrointestinal: Infrequent: Abdominal discomfort,
diarrhea, dysphagia, and gastroesophogeal reflux. Rare: Constipation,
flatulence/eructation, hematemesis, intestinal
obstruction, melena, gastroenteritis, colitis, hemorrhage
of gastrointestinal
tract, and pancreatitis.
Mouth and Teeth: Infrequent: Disorder of mouth and
tongue (e.g., burning
of tongue, numbness of tongue,
dry mouth).
Musculoskeletal: Infrequent: Neck pain/stiffness,
backache, weakness, joint symptoms,
arthritis, and myalgia. Rare: Muscle cramps, tetany, intervertebral
disc disorder, and muscle
stiffness.
Neurological: Infrequent: Drowsiness/sedation, anxiety,
sleep disturbances, tremors,
syncope, shivers, chills, depression, agitation, sensation
of lightness, and mental confusion.
Rare: Difficulty concentrating, hunger, lacrimation, memory disturbances,
monoplegia/diplegia, apathy, disturbance
of smell, disturbance
of emotions, dysarthria, facial pain, intoxication, stress, decreased
appetite, difficulty coordinating, euphoria, and neoplasm
of pituitary.
Respiratory: Infrequent: Dyspnea and lower respiratory
tract infection. Rare: Asthma.
Skin: Infrequent: Rash/skin eruption, pruritis,
and erythema. Rare: Herpes, swelling
of face, sweating, and peeling of skin.
Urogenital: Infrequent: Dysuria, disorder
of breasts, and dysmenorrhea. Rare: Endometriosis and increased
urination.
Miscellaneous: Infrequent: Cough, edema, and fever.
Rare: Hypersensitivity, swelling
of extremities, voice disturbances,
difficulty in walking, and lymphadenopathy.
Other Events Observed in the Clinical Development of Sumatriptan
The following adverse events occurred in clinical
trials with sumatriptan succinate injection
and tablets. Because the reports include events observed in open
and uncontrolled studies, the role
of sumatriptan in their causation cannot be reliably determined. All reported
events are included except those already listed, those too general to
be informative, and those not reasonably associated with the use of the
drug.
Breasts: Breast swelling, cysts, lumps, and masses of breasts;
nipple discharge; primary malignant
breast neoplasm; and tenderness.
Cardiovascular: Abnormal pulse, angina, atherosclerosis,
cerebral ischemia, cerebrovascular
lesion, heart block, peripheral
cyanosis, pulsating sensations, Raynaud syndrome, thrombosis, transient
myocardial ischemia, various transient
ECG changes (nonspecific ST
or T wave changes, prolongation
of PR or QTc intervals, sinus
arrhythmia, nonsustained ventricular premature beats, isolated junctional
ectopic beats, atrial
ectopic beats, delayed activation
of the right ventricle), and
vasodilation.
Ear, Nose, and Throat: Allergic rhinitis; ear, nose, and
throat hemorrhage; external
otitis; feeling of fullness
in the ear(s); hearing disturbances; hearing
loss; nasal inflammation; sensitivity
to noise; sinusitis; tinnitus; and upper respiratory inflammation.
Endocrine and Metabolic: Dehydration; endocrine
cysts, lumps, and masses; elevated thyrotropin
stimulating hormone (TSH)
levels; fluid disturbances; hyperglycemia; hypoglycemia; polydipsia; and
weight gain.
Eye: Accommodation disorders, blindness
and low vision, conjunctivitis, disorders of sclera, external
ocular muscle
disorders, eye edema and swelling,
eye itching, eye
hemorrhage, eye pain, keratitis,
mydriasis, and vision alterations.
Gastrointestinal: Abdominal distention, dental
pain, disturbances of liver
function tests, dyspeptic
symptoms, feelings of gastrointestinal pressure gallstones, gastric
symptoms, gastritis, gastrointestinal
pain, hypersalivation, hyposalivation, oral
itching and irritation, peptic
ulcer, retching, salivary gland
swelling, and swallowing
disorders.
Hematological Disorders: Anemia.
Injection Site Reactions.
Miscellaneous: Contusions, fluid
retention, hematoma, hypersensitivity to various agents, wjaw
discomfort, miscellaneous laboratory abnormalities, overdose, “serotonin
agonist effect”, and speech
disturbance.
Musculoskeletal: Acquired musculoskeletal
deformity, arthralgia and articular rheumatitis, muscle
atrophy, muscle tiredness,
musculoskeletal inflammation, need
to flex calf
muscles, rigidity, tightness, and various joint disturbances (pain, stiffness,
swelling, ache).
Neurological: Aggressiveness, bradylogia, cluster
headache, convulsions, detachment, disturbances of taste, drug
abuse, dystonia, facial paralysis, globus
hystericus, hallucinations, headache, heat
sensitivity, hyperesthesia, hysteria, increased alertness, malaise/fatigue,
migraine, motor dysfunction, myoclonia, neuralgia, neurotic
disorders, paralysis, personality change, phobia, photophobia, psychomotor
disorders, radiculopathy, raised intracranial
pressure, relaxation, stinging sensations, transient hemiplegia, simultaneous
hot and cold
sensations, suicide, tickling
sensations, twitching, and yawning.
Pain and Other Pressure Sensations: Chest pain, neck
tightness/pressure, throat/jaw pain/tightness/pressure, and pain
(location specified).
Respiratory: Breathing disorders, bronchitis, diseases
of the lower respiratory tract, hiccoughs, and influenza.
Skin: Dry/scaly skin, eczema, seborrheic
dermatitis, skin nodules, skin
tenderness, tightness of skin, and wrinkling of skin.
Urogenital: Abortion, abnormal
menstrual cycle, bladder inflammation, hematuria, inflammation
of fallopian tubes, intermenstrual bleeding, menstruation
symptoms, micturition
disorders, renal calculus, urethritis,
urinary frequency, and urinary infections.
Postmarketing Experience
See SIDE EFFECTS
, Postmarketing
Experience in the Oral product information.
DRUG ABUSE AND DEPENDENCE
One clinical study with
sumatriptan succinate injection
enrolling 12 patients with a history of substance
abuse failed to induce subjective
behavior and/or physiological
response ordinarily associated
with drugs that have an established potential
for abuse.
DRUG INTERACTIONS
See DRUG INTERACTIONS
in the Oral product
information.
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