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Axert

Last reviewed on RxList: 6/20/2019
Axert Side Effects Center

Last reviewed on RxList 6/20/2019

Axert (almotriptan malate) is a triptan, which works by affecting a certain natural chemical (serotonin) that constricts blood vessels in the brain, used to treat migraine headaches in adults and in adolescents who are at least 12 years old. Axert will only treat a headache that has already begun. Axert will not prevent headaches or reduce the number of attacks. Common side effects of Axert include:

  • mild headache (not a migraine),
  • drowsiness,
  • dizziness,
  • nausea,
  • vomiting,
  • sensations of tingling/numbness/prickling/warmth under your skin,
  • dry mouth,
  • elevated blood pressure, or
  • pressure or heavy feeling in any part of your body.

Chest/jaw/neck tightness can commonly occur shortly after using Axert. Seek immediate medical attention if you have unlikely but very serious (rarely fatal) side effects of Axert including:

  • chest pain,
  • jaw or left arm pain,
  • fainting,
  • fast/irregular/pounding heartbeat,
  • vision changes,
  • weakness on one side of the body,
  • confusion,
  • slurred speech,
  • sudden or severe stomach or abdominal pain, bloody diarrhea, or a change in the amount of urine.

The recommended dose of Axert in adults and adolescents age 12 to 17 years is 6.25 mg to 12.5 mg, with the 12.5 mg dose tending to be a more effective dose in adults. Axert may interact with other migraine headache medications, diclofenac, isoniazid, antidepressants, antibiotics, antifungals, heart or blood pressure medications, or HIV/AIDS medicines. Tell your doctor all medications you use. Axert should be used only when prescribed during pregnancy. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Axert (almotriptan malate) 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.

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16 Surprising Headache Triggers and Tips for Pain Relief See Slideshow
Axert Consumer Information

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

Stop using almotriptan and get emergency medical help if you have heart attack symptoms: chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating, and feeling light-headed.

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

  • numbness or tingling and a pale or blue-colored appearance in your fingers or toes;
  • blood circulation problems--weakness or heavy feeling in your legs, burning pain in your feet, leg cramps, hip pain, numbness or tingling in your legs;
  • high levels of serotonin in the body--agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting; or
  • stomach or intestinal problems--severe stomach pain (especially after eating), fever, nausea, vomiting, diarrhea, constipation, bloody or tarry stools.

Common side effects may include:

  • dry mouth;
  • nausea, vomiting;
  • numbness, tingling, or burning sensation;
  • dizziness, drowsiness; or
  • mild headache (not a migraine).

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 Axert (Almotriptan Malate)

QUESTION

Who suffers more frequently from migraine headaches? See Answer
Axert Professional Information

SIDE EFFECTS

Serious cardiac reactions, including myocardial infarction, have occurred following the use of AXERTR® (almotriptan malate) 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 myocardialischemia, myocardial infarction, ventricular tachycardia, and ventricular fibrillation [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS].

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

Adverse events were assessed in controlled clinical trials that included 1840 adult patients who received one or two doses of AXERTR® and 386 adult patients who received placebo. The most common adverse reactions during treatment with AXERTR® were nausea, somnolence, headache, paresthesia, and dry mouth. In long-term open-label studies where patients were allowed to treat multiple attacks for up to 1 year, 5% (63 out of 1347 patients) withdrew due to adverse experiences.

Adverse events were assessed in controlled clinical trials that included 362 adolescent patients who received AXERTR® and 172 adolescent patients who received placebo. The most common adverse reactions during treatment with AXERTR® were dizziness, somnolence, headache, paresthesia, nausea, and vomiting. In a long-term, open-label study where patients were allowed to treat multiple attacks for up to 1 year, 2% (10 out of 420 adolescent patients) withdrew due to adverse events.

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.

Commonly-Observed Adverse Reactions In Double-Blind, Placebo- Controlled AXERTR® Clinical Trials

Adults

Table 1 lists the adverse events that occurred in at least 1% of the adult patients treated with AXERTR®, and at an incidence greater than in patients treated with placebo, regardless of drug relationship.

Table 1. Incidence of Adverse Events in Controlled Clinical Trials (Reported in at Least 1% of Adult Patients Treated with AXERTR®, and at an Incidence Greater than Placebo)

System/Organ Class
Adverse Events
AXERT® 6.25 mg
(n=527)
%
AXERT® 12.5 mg
(n=1313)
%
Placebo
(n=386)
%
Digestive Disorders
  Nausea 1 2 1
  Dry mouth 1 5 0.5
Nervous System Disorders
  Paresthesia 1 1 0.5

The incidence of adverse events in controlled clinical trials was not affected by gender, weight, age, presence of aura, or use of prophylactic medications or oral contraceptives. There were insufficient data to assess the effect of race on the incidence of adverse events.

Adolescents

Table 2 lists the adverse reactions reported by 1% or more of AXERTR®-treated adolescents age 12 to 17 years in 1 placebo-controlled, double-blind clinical trial.

Table 2. Adverse Reactions Reported by ≥1% of Adolescent Patients Treated with AXERTR® in 1 Placebo-Controlled, Double-Blind Clinical Trial

System/Organ Class
Adverse Reaction
AXERT® 6.25 mg
(n=180)
%
AXERT® 12.5 mg
(n=182)
%
Placebo
(n=172)
%
Nervous System Disorders
  Dizziness 4 3 2
  Somnolence <1 5 2
  Headache 1 2 1
  Paresthesia <1 1 <1
Gastrointestinal Disorders
  Nausea 1 3 0
  Vomiting 2 0 <1

Other Adverse Reactions Observed In AXERTR® Clinical Trials

In the paragraphs that follow, the frequencies of less commonly reported adverse clinical reactions are presented. The reports include adverse reactions in 5 adult controlled studies and 1 adolescent controlled study. 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 AXERTR® and reported a reaction divided by the total number of patients exposed to AXERTR® (n=3047, all doses). 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 system organ class and enumerated in order of decreasing frequency using the following definitions: frequent adverse reactions are those occurring in 1/100 or more patients, infrequent adverse reactions are those occurring in fewer than 1/100 to 1/1000 patients, and rare adverse reactions are those occurring in fewer than 1/1000 patients.

Body: Frequent: Headache. Infrequent: Abdominal cramp or pain, Asthenia, Chills, Back pain, Chest pain, Neck pain, Fatigue, and Rigid neck. Rare: Fever and Photosensitivity reaction.

Cardiovascular: Infrequent: Vasodilation, Palpitations, and Tachycardia. Rare: Hypertension and Syncope.

Digestive: Infrequent: Diarrhea, Vomiting, Dyspepsia, Gastroenteritis, and Increased thirst. Rare: Colitis, Gastritis, Esophageal reflux, and Increased salivation.

Metabolic: Infrequent: Hyperglycemia and Increased serum creatine phosphokinase. Rare: Increased gamma glutamyl transpeptidase and Hypercholesteremia.

Musculo-Skeletal: Infrequent: Myalgia. Rare: Arthralgia, Arthritis, Myopathy, and Muscle weakness.

Nervous: Frequent: Dizziness and Somnolence. Infrequent: Tremor, Vertigo, Anxiety, Hypoesthesia, Restlessness, CNS stimulation, and Shakiness. Rare: Change in dreams, Impaired concentration, Abnormal coordination, Depressive symptoms, Euphoria, Hyperreflexia, Hypertonia, Nervousness, Neuropathy, Nightmares, Nystagmus, and Insomnia.

Respiratory: Infrequent: Pharyngitis, Rhinitis, Dyspnea, Laryngismus, Sinusitis, and Bronchitis. Rare: Hyperventilation, Laryngitis, Sneezing, and Epistaxis.

Skin: Infrequent: Diaphoresis, Pruritus, and Rash. Rare: Dermatitis and Erythema.

Special Senses: Infrequent: Ear pain and Tinnitus. Rare: Diplopia, Dry eyes, Eye pain, Otitis media, Parosmia, Scotoma, Conjunctivitis, Eye irritation, Hyperacusis, and Taste alteration.

Urogenital: Infrequent: Dysmenorrhea.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of AXERTR® . 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.

Immune System Disorders: Hypersensitivity reactions (including angioedema, anaphylactic reactions and anaphylactic shock)

Psychiatric Disorders: Confusional state, Restlessness

Nervous System Disorders: Hemiplegia, Hypoesthesia, Seizures

Eye Disorders: Blepharospasm, Visual impairment, Vision blurred

Ear and Labyrinth Disorders: Vertigo

Cardiac Disorders: Acute myocardial infarction, Coronary artery vasospasm, Angina pectoris, Tachycardia

Gastrointestinal Disorders: Abdominal discomfort, Abdominal pain, Abdominal pain upper, Colitis, Hypoesthesia oral, Swollen tongue

Skin and Subcutaneous Tissue Disorders: Cold sweat, Erythema, Hyperhidrosis

Musculoskeletal, Connective Tissue, and Bone Disorders: Arthralgia, Myalgia, Pain in extremity

Reproductive System and Breast Disorders: Breast pain

General Disorders: Malaise, Peripheral coldness.

Read the entire FDA prescribing information for Axert (Almotriptan Malate)

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