Drug Safety-related Labeling Changes (SrLC)

Get Email Alerts | Guide

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.

ACTICLATE (NDA-205931)

(DOXYCYCLINE HYCLATE)

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

Download Data

Expand all

03/31/2025 (SUPPL-6)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.5 Severe Skin Reactions

Additions and revisions underlined:

Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in patients receiving doxycycline. Fixed drug eruptions have occurred with doxycycline and have been associated with worsening severity upon subsequent administrations, including generalized bullous fixed drug eruption [see Adverse Reactions (6)]. If severe skin reactions occur, discontinue ACTICLATE or ACTICLATE CAP immediately and institute appropriate therapy.

6 Adverse Reactions

Additions and revisions underlined:

Skin: Maculopapular and erythematous rashes, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, and erythema multiforme, and fixed drug eruption have been reported.

. . .

Psychiatric: Depression, anxiety, suicidal ideation, insomnia, abnormal dreams, hallucination

12/26/2019 (SUPPL-4)

Approved Drug Label (PDF)

5 Warnings and Precautions

Tooth Development

(Newly added information)

Advise the patient of the potential risk to the fetus if ACTICLATE or ACTICLATE CAP is used during pregnancy [see Use in Specific Populations (8.1, 8.4)].

Inhibition of Bone Growth

(Newly added subsection; see label for complete information)

8 Use in Specific Populations

Females and Males of Reproductive Potential

(PLLR conversion. Please refer to label for complete information.)

Lactation

(PLLR conversion. Please refer to label for complete information.)

Pregnancy

(PLLR conversion. Please refer to label for complete information.)

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

PATIENT COUNSELING INFORMATION

Tooth Discoloration and Inhibition of Bone Growth

Advise patients that ACTICLATE and ACTICLATE CAP, like other tetracycline-class drugs, may cause

permanent tooth discoloration of deciduous teeth and reversible inhibition of bone growth when

administered during pregnancy. Tell your healthcare provider right away if you become pregnant during

treatment [see Warnings and Precautions (5.1,5.2) and Use in Specific Populations (8.1, 8.4)].

Lactation

Advise women not to breastfeed during treatment with ACTICLATE or ACTICLATE CAP and for 5

days after the last dose [see Use in Specific Populations (8.2)].

11/15/2017 (SUPPL-3)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.5 Severe Skin Reactions

(Newly added subsection)

6 Adverse Reactions

(Additions and/or revisions are underlined)

Gastrointestinal: Anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, inflammatory lesions (with monilial overgrowth) in the anogenital region, and pancreatitis. Hepatotoxicity has been reported. These reactions have been caused by both the oral and parenteral administration of tetracyclines. Superficial discoloration of the adult permanent dentition, reversible upon drug discontinuation and professional dental cleaning has been reported. Permanent tooth discoloration and enamel hypoplasia may occur with drugs of the tetracycline class when used during tooth development…

Hypersensitivity reactions: Urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, serum sickness, pericarditis, exacerbation of systemic lupus erythematosus, and drug reaction with eosinophilia and systemic symptoms (DRESS).