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Typhim

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Typhim

Typhim

Typhim Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Typhim (typhoid vi polysaccharide vaccine) is used to help prevent typhoid fever in adults and children who are at least 2 years old. Typhoid is a serious disease caused by Salmonella typhi bacteria and can be fatal if left untreated. The vaccine is recommended for people who are traveling to areas where the infection is common (e.g., Africa, Asia, Central/South America), those who are in close contact to someone with persistent typhoid infection, and those who work with the bacteria in a laboratory. It is an immunization.

Common side effects include redness, tenderness, hardening skin, and pain at the injection site. Headache or muscle pain may also occur. The immunizing dose of Typhim for adults and children is a single injection of 0.5 mL. Typhim may interact with blood thinners. Other drugs may affect this vaccine. Tell your doctor all medications you use, and all other vaccines you have recently received. During pregnancy, Typhim should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Typhim (typhoid vi polysaccharide vaccine) 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.

Typhim in Detail - Patient Information: Side Effects

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with typhoid is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

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.

Call your doctor at once if you have any of these serious side effects:

  • fever, swollen glands, rash or itching, joint pain, or general ill feeling;
  • tremors or shaking; or
  • feeling like you might pass out.

Less serious side effects include:

  • pain, tenderness, redness, swelling, or a hard lump where the shot was given;
  • low fever;
  • headache;
  • muscle or joint pain;
  • nausea, diarrhea, stomach pain; or
  • weakness.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Typhim (Typhoid Vi Polysaccharide Vaccine) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Typhim Overview - Patient Information: Side Effects

SIDE EFFECTS: Redness, tenderness, hardening skin, and pain at the injection site may occur. Headache or muscle pain may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Infrequently, temporary symptoms such as fainting/dizziness/lightheadedness, vision changes, numbness/tingling, or seizure-like movements have happened after vaccine injections. Tell your health care provider right away if you have any of these symptoms soon after receiving an injection. Sitting or lying down may relieve symptoms.

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.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US, you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Typhim (Typhoid Vi Polysaccharide Vaccine)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Typhim FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Adverse event information is derived from clinical trials and worldwide post-marketing experience.

Data From Clinical Trials

Because clinical trials are conducted under widely varying conditions, adverse reactions 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 practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

Safety of Typhim (typhoid vi polysaccharide vaccine) Vi vaccine, the US licensed liquid formulation, has been assessed in clinical trials in more than 4,000 subjects both in countries of high and low endemicity. In addition, the safety of the lyophilized formulation has been assessed in more than 6,000 individuals. The adverse reactions were predominately minor and transient local reactions. Local reactions such as injection site pain, erythema and induration almost always resolved within 48 hours of vaccination. Elevated oral temperature, above 38°C (100.4°F), were reported in these clinical trials.10,11

Adverse reactions from two trials evaluating Typhim (typhoid vi polysaccharide vaccine) Vi vaccine lots in the US (18- to 40-year-old adults) are summarized in TABLE 3. No severe or unusual side effects were observed. Most subjects reported pain and/or tenderness (pain upon direct pressure). Local adverse experiences were generally limited to the first 48 hours.10,11

TABLE 310,11: PERCENTAGE OF 18- TO 40-YEAR-OLD US ADULTS PRESENTING WITH LOCAL OR SYSTEMIC REACTIONS WITHIN 48 HOURS AFTER THE FIRST IMMUNIZATION WITH TYPHIM (typhoid vi polysaccharide vaccine) Vi VACCINE

REACTION Trial 1
Placebo
N = 54
Trial 1
Typhim (typhoid vi polysaccharide vaccine) Vi vaccine
N = 54
(1 Lot)
Trial 2
Typhim (typhoid vi polysaccharide vaccine) Vi vaccine
N = 98
(2 Lots combined)
Local
  Tenderness 7 (13.0%) 53 (98.0%) 95 (96.9%)
  Pain 4 (7.4%) 22 (40.7%) 26 (26.5%)
  Induration 0 8 (14.8%) 5 (5.1%)
  Erythema 0 2 (3.7%) 5 (5.1%)
Systemic
  Malaise 8 (14.8%) 13 (24.0%) 4 (4.1%)
  Headache 7 (13.0%) 11 (20.4%) 16 (16.3%)
  Myalgia 0 4 (7.4%) 3 (3.1%)
  Nausea 2 (3.7%) 1 (1.9%) 8 (8.2%)
  Diarrhea 2 (3.7%) 0 3 (3.1%)
  Feverish (subjective) 0 6 (11.1%) 3 (3.1%)
  Fever ≥ 100°F 0 1 (1.9%) 0
  Vomiting 0 1 (1.9%) 0

No studies were conducted in US children. Adverse reactions from a trial in Indonesia in children one to twelve years of age are summarized in TABLE 4.10,11 No severe or unusual side effects were observed.

TABLE 410,11: PERCENTAGE OF INDONESIAN CHILDREN ONE TO TWELVE YEARS OF AGE PRESENTING WITH LOCAL OR SYSTEMIC REACTIONS WITHIN 48 HOURS AFTER THE FIRST IMMUNIZATION WITH TYPHIM (typhoid vi polysaccharide vaccine) Vi VACCINE

REACTIONS N = 175
Local
  Soreness 23 (13.0%)
  Pain 25 (14.3%)
  Erythema 12 (6.9%)
  Induration 5 (2.9%)
  Impaired Limb Use 0
Systemic
  Feverishness* 5 (2.9%)
  Headache 0
  Decreased Activity 3 (1.7%)
* Subjective feeling of fever.

In the US Reimmunization Study, subjects who had received Typhim (typhoid vi polysaccharide vaccine) Vi vaccine 27 or 34 months earlier, and subjects who had never previously received a typhoid vaccination, were randomized to placebo or Typhim (typhoid vi polysaccharide vaccine) Vi vaccine, in a double-blind study. Safety data from the US Reimmunization Study are presented in TABLE 5.10,11,13 In this study 5/30 (17%) primary immunization subjects and 10/45 (22%) reimmunization subjects had a local reaction. No severe or unusual side effects were observed. Most subjects reported pain and/or tenderness (pain upon direct pressure). Local adverse experiences were generally limited to the first 48 hours.10,11,13

TABLE 510,11,13: US REIMMUNIZATION STUDY, SUBJECTS PRESENTING WITH LOCAL AND SYSTEMIC REACTIONS WITHIN 48 HOURS AFTER IMMUNIZATION WITH TYPHIM (typhoid vi polysaccharide vaccine) Vi VACCINE DATA FROM WORLDWIDE POST-MARKETING EXPERIENCE

REACTIONS PLACEBO
(N = 32)
FIRST IMMUNIZATION
(N = 30)
REIMMUNIZATION
(N = 45*)
Local
  Tenderness 2 (6%) 28 (93%) 44 (98%)
  Pain 1 (3%) 13 (43%) 25 (56%)
  Induration 0 5 (17%) 8 (18%)
  Erythema 0 1 (3%) 5 (11%)
Systemic
  Malaise 1 (3%) 11 (37%) 11 (24%)
  Headache 5 (16%) 8 (27%) 5 (11%)
  Myalgia 0 2 (7%) 1 (2%)
  Nausea 0 1 (3%) 1 (2%)
  Diarrhea 0 0 1 (2%)
  Feverish (subjective) 0 3 (10%) 2 (4%)
  Fever 1 (3%) 0 1 (2%)
  Vomiting 0 0 0
* At 27 or 34 months following a previous dose given in different studies.

The following adverse events have been reported during post-approval use of Typhim (typhoid vi polysaccharide vaccine) Vi vaccine. These events have been very rarely reported, however, because they were reported voluntarily from a population of uncertain size, it is not always possible to reliably calculate their frequencies or to establish a causal relationship to Typhim (typhoid vi polysaccharide vaccine) Vi vaccine exposure.

Data are organized by MedDRA system organ class and within system organ class, by order of descreasing frequency.

- Gastro intestinal disorders

Nausea, vomiting, diarrhea.

- General disorders and administration site condition

Local Reactions: injection site pain, injection site inflammation, injection site induration, injection site erythema, and lymphadenopathy. Fever, asthenia, malaise, flu-like episode, abdominal pain.

-Immune system disorders

Allergic-type reactions such as pruritus, rash, urticaria, difficulty breathing, hypotension. Serum sickness.

- Musculoskeletal and connective tissue disorders

Myalgia, arthralgia, cervical pain.

- Nervous system disorders

Headache, loss of consciousness, tremor.

Additional Adverse Events: Post-marketing reports of glomerulonephritis, neutropenia, bilateral retinitis, and polyarthritis have been reported in patients who had also received other vaccines; however a causal relationship has not been established.

Reporting of Adverse Events

Reporting by parents and patients of all adverse events occurring after vaccine administration should be encouraged. Adverse events following immunization with vaccine should be reported by the health-care provider to the US Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting System (VAERS). Reporting forms and information about reporting requirements or completion of the form can be obtained from VAERS through a toll-free number 1-800-822-7967 or visit the VAERS website at http//www.vaers.org.17

Health-care providers also should report these events to the Pharmocovigilance Department, Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370, or call 1-800-822-2463.

Read the entire FDA prescribing information for Typhim (Typhoid Vi Polysaccharide Vaccine) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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