Florbetapir f 18 side effects

What does the label list?

From the label: adverse reactions

Most common adverse reactions (incidence ≥ 0.4%) were headache, musculoskeletal pain, increased blood pressure, nausea, fatigue, injection site reaction, anxiety, back pain, claustrophobia, dizziness, feeling cold, insomnia, and neck pain.

Table 2: Adverse Reactions Reported in ≥ 0.4% of Adult Subjects Who Received AMYVID in Clinical Trials

Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.

From the label: adverse reactions, continued

Most common adverse reactions (incidence ≥ 0.4%) were headache, musculoskeletal pain, increased blood pressure, nausea, fatigue, injection site reaction, anxiety, back pain, claustrophobia, dizziness, feeling cold, insomnia, and neck pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-545-5979 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of AMYVID was evaluated in 555 adult subjects who received AMYVID by intravenous injection in clinical trials. Table 2 shows adverse reactions reported in ≥ 0.4% of subjects from the clinical trials. Table 2: Adverse Reactions Reported in ≥ 0.4% of Adult Subjects Who Received AMYVID in Clinical Trials a Includes the terms blood pressure increased and hypertension. b Includes the terms injection site hemorrhage, injection site irritation, and injection site pain. c Includes the terms feeling cold and chills. …

What do FAERS reports show?

113 reports list florbetapir f 18 among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 12 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 23 reactions below, 7 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

The 25 most reported reactions

• Amyloid Related Imaging Abnormality-Oedema/Effusion28
• Amyloid Related Imaging Abnormality-Microhaemorrhages And Haemosiderin Deposits27
• Headache (named in the label)14
• Superficial Siderosis Of Central Nervous System9
• Injection Site Pain (named in the label)7
• Chest Pain4
• Fall4
• Fatigue (named in the label)4
• Nausea (named in the label)4
• Balance Disorder3
• Burning Sensation3
• Confusional State3
• Drug Ineffective (a use or a product term, not a reaction)3
• Erythema3
• False Negative Investigation Result3
• Flushing (named in the label)3
• Migraine3
• Pain In Extremity3
• Rash Macular3
• Vomiting3
• Wrong Technique In Product Usage Process (a use or a product term, not a reaction)3
• Blood Pressure Decreased2
• Blood Pressure Increased (named in the label)2
• Dehydration2
• Dizziness (named in the label)2

What next?

Florbetapir f 18: the full record

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