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Zomig Nasal Spray

  • Generic Name: zolmitriptan nasal spray
  • Brand Name: Zomig Nasal Spray

Zomig Nasal Spray (Zolmitriptan Nasal Spray) side effects drug center

 

PROFESSIONAL

CONSUMER

SIDE EFFECTS

 

Zomig Nasal Spray Side Effects Center

What Is Zomig Nasal Spray?

Zomig (zolmitriptan) Nasal Spray is a headache medicine that narrows blood vessels around the brain used to treat migraine headaches. Zomig Nasal Spray will only treat a headache that has already begun. Zomig Nasal Spray will not prevent headaches or reduce the number of attacks.

What Are Side Effects of Zomig Nasal Spray?

Common side effects of Zomig Nasal Spray include:

  • unusual or unpleasant taste in your mouth,
  • discomfort in the nose or throat after using the nasal spray,
  • warmth/redness/tingling/numbness under the skin,
  • nausea,
  • dry mouth,
  • weakness,
  • drowsiness,
  • dizziness, or
  • pressure or heavy feeling in any part of your body.

Dosage for Zomig Nasal Spray

The initial dose of Zomig is 2.5 mg or less. The dose can be repeated after 2 hours if symptoms persist. The maximum dose is 10 mg per day.

What Drugs, Substances, or Supplements Interact with Zomig Nasal Spray?

Zomig may interact with other migraine headache medicines, cimetidine, or antidepressants. Tell your doctor all medications you are taking.

Zomig Nasal Spray During Pregnancy and Breastfeeding

During pregnancy, Zomig should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Additional Information

Our Zomig (zolmitriptan) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Zomig Nasal Spray Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

  • feeling of pain or tightness in your jaw, neck, or throat;
  • sudden and severe stomach pain and bloody diarrhea;
  • bowel problems, weight loss, fever, stomach pain after meals;
  • cramps or pain in your legs or hips;
  • numbness, tingling, burning pain, coldness, and a pale or blue-colored appearance in your fingers or toes;
  • irregular heartbeats;
  • heart attack symptoms--chest pain or pressure, pain spreading to your shoulder, nausea, sweating;
  • signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance; or
  • high levels of serotonin in the body--agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.

Common side effects may include:

  • unusual or unpleasant taste in your mouth;
  • numbness;
  • dizziness; or
  • skin being more sensitive than usual.

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)

 

Zomig Nasal Spray Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in more detail in other sections of labeling:

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
(N=228)		 Zomig 2.5 mg
(N=224)		 Zomig 5mg
(N=236)
Atypical Sensations
Hyperesthesia 0% 1% 5%
Paraesthesia 6% 5% 10%
Sensation warm 2% 4% 0%
Ear/Nose/Throat
Disorder/Discomfort of nasal cavity 2% 1% 3%
Pain and Pressure Sensations
Pain Location Specified 1% 2% 4%
Pain Throat 1% 4% 4%
Tightness Throat 1% < 1% 2%
Digestive
Dry Mouth < 1% 3% 2%
Nausea 1% 1% 4%
Neurological
Dizziness 4% 6% 3%
Somnolence 2% 1% 4%
Other
Unusual Taste 3% 17% 21%
Asthenia 1% 3% 3%

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.

Cardiovascular: Infrequent: arrhythmias, hypertension, syncope and tachycardia. Rare: angina pectoris and myocardial infarct.

Digestive: Rare: stomatitis.

Neurological: Infrequent: agitation, amnesia, anxiety, depression, insomnia, and nervousness. Rare: convulsions.

Respiratory: Infrequent: bronchitis, increased cough, dyspnea, epistaxis, laryngeal edema, pharyngitis, rhinitis, and sinusitis.

Skin: Infrequent: pruritus, rash, and urticaria.

Urogenital: Infrequent: polyuria and urinary urgency. Rare: urinary frequency.

Special senses: Infrequent: tinnitus. Rare: conjunctivitis, dry eye, and visual field defect.

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).

Postmarketing Experience

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.

Hypersensitivity Reactions

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)

&Copy; Zomig Nasal Spray Patient Information is supplied by Cerner Multum, Inc. and Zomig Nasal Spray Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.