Zomig Nasal Spray
"Today, the U.S. Food and Drug Administration approved Topamax (topiramate) for prevention (prophylaxis) of migraine headaches in adolescents ages 12 to 17. This is the first FDA approval of a drug for migraine prevention in this age group. The me"...
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:
- 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.
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 right away if you have any serious side effects, including: blue fingers/toes/nails, cold hands/feet.
Chest/jaw/neck tightness can commonly occur soon after using zolmitriptan. Only rarely are these signs of a serious condition. However, you may not be able to tell it apart from a serious reaction due to a lack of blood flow to the heart, brain, or other parts of the body. Get medical help right away if you have any very serious side effects, including: chest pain, jaw/left arm pain, fainting, fast/irregular/pounding heartbeat, vision changes, weakness on one side of the body, confusion, slurred speech, sudden or severe stomach/abdominal pain, bloody diarrhea, change in the amount of urine.
This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.
A very serious allergic reaction to this drug is rare. However, get medical help right away 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
The following adverse reactions are discussed in more detail in other sections of labeling:
- Myocardial Ischemia, Myocardial Infarction, and Prinzmetal's Angina [see WARNINGS AND PRECAUTIONS]
- Arrhythmias [see WARNINGS AND PRECAUTIONS]
- Chest and or Throat, Neck and Jaw Pain/Tightness/Pressure [see WARNINGS AND PRECAUTIONS]
- Cerebrovascular Events [see WARNINGS AND PRECAUTIONS]
- Other Vasospasm Reactions [see WARNINGS AND PRECAUTIONS]
- Medication Overuse Headache [see WARNINGS AND PRECAUTIONS]
- Serotonin Syndrome [see WARNINGS AND PRECAUTIONS]
- Increase in Blood Pressure [see WARNINGS AND PRECAUTIONS]
Clinical Trials 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.
Among 460 patients treating 1180 single attacks with zolmitriptan nasal spray in a blinded placebo controlled trial (Study 1), there was a low withdrawal rate related to adverse reactions: 5 mg (1.3%), 2.5 mg (0%), and placebo (0.4%). None of the withdrawals were due to a serious event. One patient was withdrawn due to abnormal ECG changes from baseline that were incidentally found 23 days after the last dose of ZOMIG Nasal Spray.
The most common adverse reactions ( ≥ 5% and > placebo) in any dosage strength in clinical trials for ZOMIG Nasal Spray were: unusual taste, paresthesia, hyperesthesia, and dizziness. The incidence of adverse reactions was generally dose-related.
Table 1 lists the adverse reactions from the controlled clinical trial (Study 1) that occurred in ≥ 2% of patients in either the 2.5 or 5 mg zolmitriptan nasal spray dose groups and with an incidence greater than placebo.
Table 1: Adverse reactions with an incidence of ≥ 2%
and greater than placebo of patients in each of the ZOMIG 2.5 and 5 mg nasal
spray treatment groups by body system.
|Body system and adverse reaction||Placebo
|Zomig 2.5 mg
|Disorder/Discomfort of nasal cavity||2%||1%||3%|
|Pain and Pressure Sensations|
|Pain Location Specified||1%||2%||4%|
|Tightness Throat||1%||< 1%||2%|
|Dry Mouth||< 1%||3%||2%|
In Study 1, adverse clinical reactions occurring in ≥ 1% and < 2% of patients in all attacks in either zolmitriptan nasal spray dose group and with incidence greater than that of placebo were pain abdominal, chills, pressure throat, edema face, pressure chest, palpitation, dysphagia, arthralgia, myalgia, and depersonalization.
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 460 patients using ZOMIG 2.5mg or 5mg in the controlled clinical trial, 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 57% 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 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 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 Nasal Spray and reported a reaction divided by the total number of patients exposed to ZOMIG 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.
General: Infrequent: allergic reactions.
Digestive: Rare: stomatitis.
Neurological: Infrequent: agitation, amnesia, anxiety, depression, insomnia, and nervousness. Rare: convulsions.
Urogenital: Infrequent: polyuria and urinary urgency. Rare: urinary frequency.
The adverse experience profile seen with ZOMIG Nasal Spray is similar to that seen with ZOMIG tablets and ZOMIG-ZMT tablets except for the occurrence of local adverse reactions from the nasal spray (see ZOMIG tablet/ZOMIG-ZMT oral disintegrating tablet Prescribing Information).
The following adverse reactions were identified during post approval use of ZOMIG. 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 reactions enumerated include all except those already listed in the Clinical Trials Experience section above or the Warnings and Precautions section.
As with other 5-HT1B/1D agonists, there have been reports of anaphylaxis, anaphylactoid, and hypersensitivity reactions including angioedema in patients receiving ZOMIG. ZOMIG is contraindicated in patients with a history of hypersensitivity reaction to ZOMIG.
Read the entire FDA prescribing information for Zomig Nasal Spray (Zolmitriptan Nasal Spray) »
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