Zomig Nasal Spray
Migraines' Brain Changes Not Linked to Mental Harm »
"Nov. 13, 2012 -- Women who get migraines are more likely than those who don't to develop small areas of tissue changes in their brains, a new study shows. At the same time, these changes do not seem to affect the women's thinking or memory.
"...Read the Migraines' Brain Changes Not Linked to Mental Harm article »
Zomig Nasal Spray
Zomig Nasal Spray Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Zomig (zolmitriptan) Nasal spray is used to treat migraine headaches. It will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks. It is a headache medicine that narrows blood vessels around the brain. Common side effects include unusual taste, discomfort in the nose, tingling/numbness, nausea, dry mouth, weakness, drowsiness, or dizziness.
Administer one dose of Zomig Nasal Spray 5 mg for the treatment of acute migraine. If the headache returns, the dose may be repeated after 2 hours. Zomig may interact with cimetidine, or antidepressants. Tell your doctor all medications and supplements you use. During pregnancy, Zomig should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Our Zomig (zolmitriptan) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Zomig Nasal Spray in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using zolmitriptan and call your doctor at once if you have a serious side effect such as:
- feeling of pain or tightness in your jaw, neck, or throat;
- chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
- sudden numbness or weakness, especially on one side of the body;
- sudden severe headache, confusion, problems with vision, speech, or balance;
- sudden and severe stomach pain and bloody diarrhea;
- numbness or tingling and a pale or blue-colored appearance in your fingers or toes; or
- (if you are also taking an antidepressant) -- agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.
Less serious side effects may include:
- drowsiness;
- pressure or heavy feeling in any part of your body;
- nausea, dry mouth, unusual or unpleasant taste in your mouth;
- pain or discomfort in your nose or throat after using the nasal spray; or
- warmth, redness, or mild tingling under your skin.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Zomig Nasal Spray (Zolmitriptan Nasal Spray) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Zomig Nasal Spray Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: blue fingers/toes/nails, cold feeling in the hands/feet.
Pain/pressure/tightness in the chest/neck/jaw can occur shortly after using zolmitriptan. These side effects are usually not serious. However, you may not be able to tell them apart from a rare but very serious reaction related to a lack of blood flow to the heart, brain, or other parts of the body. Therefore, seek immediate medical attention if you notice any of these unlikely side effects: chest/jaw/left arm pain, fainting, irregular/pounding heartbeat, vision changes, severe nausea, weakness on one side of the body, confusion, seizures, slurred speech, sudden or severe stomach/abdominal pain, trouble swallowing, bloody diarrhea.
This medication may rarely cause a very serious condition called serotonin syndrome. The risk increases when this medication is used with certain other drugs such as other "triptans" used to treat migraine headaches (e.g., sumatriptan, eletriptan), certain antidepressants including SSRIs (e.g., citalopram, fluoxetine, paroxetine) and NSRIs (e.g., duloxetine, venlafaxine), or a certain drug to treat obesity (sibutramine). Before using this drug, tell your doctor if you take any of these medications. Serotonin syndrome may be more likely when you start or increase the dose of any of these medications. Seek immediate medical attention if you develop some of the following symptoms: hallucinations, unusual restlessness, loss of coordination, fast heartbeat, severe dizziness, high fever, severe nausea/vomiting/diarrhea, twitchy muscles.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Zomig Nasal Spray (Zolmitriptan Nasal Spray)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Zomig Nasal Spray FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
Clinical Studies Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Serious cardiac reactions, including myocardial infarction, have occurred following the use of ZOMIG (zolmitriptan nasal spray) Tablets. These reactions are extremely rare and most have been reported in patients with risk factors predictive of CAD. Reactions reported, in association with triptans, have included coronary artery vasospasm, transient myocardial ischemia, myocardial infarction, ventricular tachycardia, and ventricular fibrillation [see CONTRAINDICATIONS, and WARNINGS AND PRECAUTIONS].
Incidence in Controlled Clinical Trials
Among 464 adult patients treating single attacks with zolmitriptan nasal spray in a blinded placebo controlled trial, there was a low withdrawal rate related to adverse reactions: 5 mg (1.3%), and placebo (0.4%). None of the withdrawals were due to a serious reaction. One patient was withdrawn due to abnormal ECG changes from baseline that was incidentally found 23 days after the last dose of ZOMIG (zolmitriptan nasal spray) Nasal Spray. The most common adverse reactions in clinical trials for ZOMIG (zolmitriptan nasal spray) Nasal Spray were: unusual taste, paresthesia, hyperesthesia, and dizziness.
Table 1 lists the adverse reactions that occurred in ≥ 2% of the 236 patients in the 5 mg dose group of the controlled clinical trial.
Table 1: Adverse reactions with an incidence of ≥ 2% of
patients in the zolmitriptan 5 mg nasal spray treatment group by body system
and greater than placebo.
| Body system and adverse reaction | Placebo (N=228) |
5.0 mg (N=236) |
| Atypical Sensations | ||
| Hyperesthesia | 0% | 5% |
| Paraesthesia | 6% | 10% |
| Ear/Nose/Throat | ||
| Disorder/Discomfort of nasal cavity | 2% | 3% |
| Pain and Pressure Sensations | ||
| Pain Location Specified | 1% | 4% |
| Pain Throat | 1% | 4% |
| Tightness Throat | 1% | 2% |
| Digestive | ||
| Dry Mouth | 0% | 2% |
| Nausea | 1% | 4% |
| Neurological | ||
| Somnolence | 2% | 4% |
| Unusual Taste | 3% | 21% |
| Other | ||
| Asthenia | 1% | 3% |
Adverse clinical reactions occurring in ≥ 1% and < 2% of patients in all attacks of the controlled clinical trial were pain abdominal, pressure throat, vomiting, headache, tightness chest, dysphagia, insomnia, palpitation and reaction aggravation.
The incidence of adverse reactions in controlled clinical trials was not affected by gender, weight, or age of the patients (18-39 vs. 40-65 years of age), or presence of aura. There were insufficient data to assess the impact of race on the incidence of adverse reactions.
Local Adverse Reactions
Among 922 patients using the zolmitriptan nasal spray to treat 2311 attacks in the controlled clinical study who were exposed, across all doses (0.5 to 5 mg), approximately 3% noted local irritation or soreness at the site of administration. Adverse reactions of any kind, perceived in the nasopharynx (which may include systemic effects of triptans) were severe in about 1% of patients and approximately 60% resolved in 1 hour. Nasopharyngeal examinations, in a subset of patients participating in two long term trials of up to one year duration, failed to demonstrate any clinically significant changes with repeated use of ZOMIG (zolmitriptan nasal spray) Nasal Spray.
All nasopharyngeal adverse reactions with an incidence of ≥ 2% of patients in any zolmitriptan nasal spray dose groups are included in ADVERSE REACTIONS Table 1.
Other Adverse Reactions
In the paragraphs that follow, the frequencies of less commonly reported adverse clinical reactions are presented. Because the reports include reactions observed in open and uncontrolled studies, the role of ZOMIG (zolmitriptan nasal spray) in their causation cannot be reliably determined. Furthermore, variability associated with adverse reaction reporting, the terminology used to describe adverse reactions, etc., limit the value of the quantitative frequency estimates provided. Reaction frequencies are calculated as the number of patients who used ZOMIG (zolmitriptan nasal spray) Nasal Spray and reported a reaction divided by the total number of patients exposed to ZOMIG (zolmitriptan nasal spray) Nasal Spray (n=3059). All reported reactions are included except those already listed in the previous table, those too general to be informative, and those not reasonably associated with the use of the drug. Reactions are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: infrequent adverse reactions are those occurring in 1/100 to 1/1,000 patients and rare adverse reactions are those occurring in fewer than 1/1,000 patients.
Body: Infrequent: allergic reaction, back pain, chills, cyst, flu syndrome, infection, jaw pain, pressure other, jaw tightening, edema of the face, abnormal laboratory test, neck pain, neoplasm, and neck tightness, chest heaviness, chest pain, and chest pressure Rare: cellulitis, fever, jaw pressure, and neck heaviness
Cardiovascular: Infrequent: arrhythmias, hypertension, syncope, thrombophlebitis, and tachycardia
Rare: angina pectoris, bradycardia, atrial fibrillation, myocardial infarct, vasodilation, and vascular disorder
Digestive: Infrequent: diarrhea, dyspepsia, tongue edema, gastrointestinal disorder, increased saliva, and thirst Rare: increased appetite, colitis, constipation, eructation, gastritis, gastrointestinal carcinoma, gingivitis, hepatic neoplasia, intestinal obstruction, jaundice, sialadenitis, and stomatitis
Endocrine System: Rare: hyperthyroidism and thyroid edema
Hemic: Infrequent: cyanosis
Rare: ecchymosis, lymphadenopathy and leukopenia
Metabolic Nutritional: Rare: increased weight, dehydration, and peripheral edema
Musculoskeletal: Infrequent: arthralgia, joint disorder, and myalgia Rare: bone pain, osteoporosis, tenosynovitis and twitching
Nervous System: Infrequent: agitation, amnesia, anxiety, ataxia, abnormal coordination, confusion, depersonalization, depression, hypertonia, insomnia, nervousness, speech disorder, abnormal thinking, tremor, vertigo, and circumoral paresthesia Rare: apathy, convulsions, abnormal dreams, euphoria, hypertonia, irritability, tardive dyskinesia, manic reaction, neuropathy, and psychosis
Respiratory: Infrequent: bronchitis, increased cough, dyspnea, epistaxis, laryngeal edema, pharyngitis, rhinitis, sinusitis, throat discomfort, and voice alteration Rare: hiccup, hyperventilation, laryngitis, pneumonia, increased sputum, and yawning
Skin: Infrequent: pruritus, rash, skin disorder, and sweating
Rare: eczema, erythema, erythema multiform, hair disorder, and neoplasm
Special Senses: Infrequent: amblyopia, disorder of lacrimation, ear pain, eye pain, parosmia and tinnitus Rare: conjunctivitis, dry eye, photophobia, and visual field defect
Urogenital: Infrequent: polyuria and menorrhagia
Rare: breast carcinoma, dysmenorrhea, metrorrhagia, breast neoplasm, unintended pregnancy, suspicious PAP smear, uterine disorder, enlarged uterine fibroids, fibrocytic breast, vaginitis, urogenital neoplasm, cystitis, urinary tract infection, kidney pain, pyelonephritis, urinary frequency, urine impaired, and urinary tract disorder The adverse experience profile seen with ZOMIG (zolmitriptan nasal spray) Nasal Spray is similar to that seen with ZOMIG (zolmitriptan nasal spray) tablets and ZOMIG (zolmitriptan nasal spray) -ZMT tablets except for the occurrence of local adverse reactions from the nasal spray (see ZOMIG (zolmitriptan nasal spray) Tablet Prescribing Information).
Postmarketing Experience with ZOMIG (zolmitriptan nasal spray) Tablets
The following adverse reactions were identified during post approval use of ZOMIG (zolmitriptan nasal spray) . Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The following section enumerates potentially important adverse reactions that have occurred in clinical practice and which have been reported spontaneously to various surveillance systems. The reactions enumerated represent reports arising from both domestic and nondomestic use of oral zolmitriptan. The reactions enumerated include all except those already listed in the ADVERSE REACTIONS section above or those too general to be informative. Because the reports cite reactions reported spontaneously from worldwide postmarketing experience, frequency of reactions and the role of zolmitriptan in their causation cannot be reliably determined.
Cardiovascular
Coronary artery vasospasm, transient myocardial ischemia, angina pectoris, and myocardial infarction.
Digestive
Very rare gastrointestinal ischemic reactions including splenic infarction, ischemic colitis and gastrointestinal infarction or necrosis have been reported; these may present as bloody diarrhea or abdominal pain [see WARNINGS AND PRECAUTIONS].
General
As with other 5-HT1B/1D agonists, there have been very rare reports of anaphylaxis or anaphylactoid reactions in patients receiving ZOMIG (zolmitriptan nasal spray) . There have been rare reports of hypersensitivity reactions, including angioedema.
Serotonin syndrome has also been reported during the postmarketing period [see WARNINGS AND PRECAUTIONS].
Neurological
As with other acute migraine treatments including other 5-HT1 agonists, there have been rare reports of headache.
Read the entire FDA prescribing information for Zomig Nasal Spray (Zolmitriptan Nasal Spray) »
Additional Zomig Nasal Spray Information
Zomig Nasal Spray - User Reviews
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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