Drug Safety-related Labeling Changes (SrLC)

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Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

TERIPARATIDE (NDA-218771)

(TERIPARATIDE)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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08/03/2026 (SUPPL-2)

Approved Drug Label (PDF)

4 Contraindications

Additions and/or revisions underlined:

Teriparatide Injection is contraindicated in patients with a history of severe hypersensitivity to teriparatide or any of the inactive ingredients of Teriparatide Injection. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions (5.1), Adverse Reactions (6.2)].

5 Warnings and Precautions

5.1 Hypersensitivity Reactions

Newly added subsection:

Hypersensitivity reactions, including anaphylaxis, angioedema, and urticaria, have been reported in patients treated with parathyroid hormone (PTH) analogs, including teriparatide [see Adverse Reactions (6.2)]. If signs or symptoms of a hypersensitivity reaction occur, discontinue treatment with Teriparatide Injection, initiate appropriate supportive care, and monitor until signs and symptoms resolve. Discontinue Teriparatide Injection permanently in patients with a severe hypersensitivity reaction to Teriparatide Injection.

6 Adverse Reactions

Additions and/or revisions underlined:

The following clinically significant adverse reactions are described elsewhere in the labeling:

Hypersensitivity Reactions [see Warnings and Precautions (5.1)]
Osteosarcoma [see Warnings and Precautions (5.2)]
Hypercalcemia and Cutaneous Calcification [see Warnings and Precautions (5.3)]
Risk of Urolithiasis [see Warnings and Precautions (5.4)]
Orthostatic Hypotension [see Warnings and Precautions (5.5)]
Risk of Digoxin Toxicity [see Warnings and Precautions (5.6)]

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

MEDICATION GUIDE

Additions and/or revisions underlined:

…

What is the most important information I should know about Teriparatide Injection?

Teriparatide Injection may cause serious side effects, including:

Allergic (hypersensitivity) reactions, including anaphylaxis. Stop taking Teriparatide Injection and get medical help right away if you have any of the following symptoms of an allergic reaction:
- swelling of your face, lips, mouth, or tongue
- fast heartbeat
- breathing problems
- itching
- fainting, dizziness, feeling lightheaded (low blood pressure)
- rash
- hives

…

Who should not use Teriparatide Injection? Do not use Teriparatide Injection if you:

have had a severe allergic reaction to teriparatide or any of the ingredients in Teriparatide Injection. Ask your healthcare provider if you are not sure. See the end of this Medication Guide for a complete list of the ingredients in Teriparatide Injection.

…

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

Advise patients to read the FDA-approved patient labeling (Medication Guide and the User Manual) before starting Teriparatide Injection and each time the prescription is renewed. Failure to follow the instructions may result in inaccurate dosing.

Hypersensitivity Reactions

Advise patients that serious hypersensitivity reactions, including anaphylaxis, angioedema, and urticaria, can occur with Teriparatide Injection. Advise patients to discontinue Teriparatide Injection and promptly seek medical attention if signs or symptoms of hypersensitivity reactions occur [see Contraindications (4), Warnings and Precautions (5.1)].

…