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 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 = 3,711) exposed to sumatriptan nasal spray. All reported events 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. 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 1/1,000 patients and rare adverse events are those occurring in fewer than 1/1,000 patients.

Atypical Sensations: Infrequent were tingling, warm/hot sensation, numbness, pressure sensation, feeling strange, feeling of heaviness, feeling of tightness, paresthesia, cold sensation, and tight feeling in head. Rare were dysesthesia and prickling sensation. 

Cardiovascular: Infrequent were flushing and hypertension (see WARNINGS), palpitations, tachycardia, changes in ECG, and arrhythmia (see WARNINGS and PRECAUTIONS). Rare were abdominal aortic aneurysm, hypotension, bradycardia, pallor, and phlebitis.

Chest Symptoms: Infrequent were chest tightness, chest discomfort, and chest pressure/heaviness (see PRECAUTIONS: General).

Ear, Nose, and Throat: Infrequent were disturbance of hearing and ear infection. Rare were otalgia and Meniere disease.

Endocrine and Metabolic: Infrequent was thirst. Rare were galactorrhea, hypothyroidism, and weight loss.

Eye: Infrequent were irritation of eyes and visual disturbance.

Gastrointestinal: Infrequent were abdominal discomfort, diarrhea, dysphagia, and gastroesophageal reflux. Rare were constipation, flatulence/eructation, hematemesis, intestinal obstruction, melena, gastroenteritis, colitis, hemorrhage of gastrointestinal tract, and pancreatitis.

Mouth and Teeth: Infrequent was disorder of mouth and tongue (e.g., burning of tongue, numbness of tongue, dry mouth).

Musculoskeletal: Infrequent were neck pain/stiffness, backache, weakness, joint symptoms, arthritis, and myalgia. Rare were muscle cramps, tetany, intervertebral disc disorder, and muscle stiffness.

Neurological: Infrequent were drowsiness/sedation, anxiety, sleep disturbances, tremors, syncope, shivers, chills, depression, agitation, sensation of lightness, and mental confusion. Rare were 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 were dyspnea and lower respiratory tract infection. Rare was asthma. 

Skin: Infrequent were rash/skin eruption, pruritus, and erythema. Rare were herpes, swelling of face, sweating, and peeling of skin.

Urogenital: Infrequent were dysuria, disorder of breasts, and dysmenorrhea. Rare were endometriosis and increased urination.

Miscellaneous: Infrequent were cough, edema, and fever. Rare were hypersensitivity, swelling of extremities, voice disturbances, difficulty in walking, and lymphadenopathy.